SIST EN ISO 15378:2018
(Main)Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP) (ISO 15378:2017)
Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP) (ISO 15378:2017)
ISO 15378:2017 specifies requirements for a quality management system when an organization:
a) needs to demonstrate its ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements, and
b) aims to enhance customer satisfaction through the effective application of the system, including processes for improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements.
All the requirements of this International Standard are generic and are intended to be applicable to any organization, regardless of its type or size, or the products and services it provides.
NOTE 1 In this International Standard, the terms "product" or "service" only apply to products and services intended for, or required by, a customer.
NOTE 2 Statutory and regulatory requirements can be expressed as legal requirements.
In addition to ISO 9001, this document specifies Good Manufacturing Practice (GMP) requirements applicable to primary packaging materials for a quality management system where an organization needs to demonstrate its ability to provide primary packaging materials for medicinal products, which consistently meet customer requirements, including regulatory requirements and International Standards.
In ISO 15378:2017 the term "if appropriate" is used several times. When a requirement is qualified by this phrase, it is deemed to be "appropriate" unless the organization can document a justification otherwise.
ISO 15378:2017 is an application standard for the design, manufacture and supply of primary packaging materials for medicinal products.
Primärpackmittel für Arzneimittel - Besondere Anforderungen für die Anwendung von ISO 9001:2015 entsprechend der Guten Herstellungspraxis (GMP) (ISO 15378:2017)
Diese Internationale Norm legt Anforderungen an ein Qualitätsmanagementsystem fest, wenn eine Organisation
a) ihre Fähigkeit darlegen muss, beständig Produkte und Dienstleistungen bereitstellen zu können, die die Anforderungen der Kunden und die zutreffenden gesetzlichen und behördlichen Anforderungen erfüllen, und
b) danach strebt, die Kundenzufriedenheit durch wirksame Anwendung des Systems zu erhöhen, ein-schließlich der Prozesse zur Verbesserung des Systems und der Zusicherung der Einhaltung von Anforderungen der Kunden und von zutreffenden gesetzlichen und behördlichen Anforderungen.
Alle in dieser Internationalen Norm festgelegten Anforderungen sind allgemeiner Natur und auf jede Organisation zutreffend, unabhängig von deren Art oder Größe oder von der Art der von ihr bereitgestellten Produkte und Dienstleistungen.
ANMERKUNG 1 In dieser Internationalen Norm bezieht sich die Benennung „Produkt“ bzw. „Dienstleistung“ nur auf solche Produkte und Dienstleistungen, die für einen Kunden vorgesehen sind oder von diesem gefordert werden.
ANMERKUNG 2 Gesetzliche und behördliche Anforderungen können auch als rechtliche Anforderungen bezeichnet werden.
Zusätzlich zu ISO 9001 legt dieses Dokument auf Primärpackmittel anwendbare Gute Herstellungspraxis (GMP)-Anforderungen für ein Qualitätsmanagementsystem fest, bei dem eine Organisation ihre Fähigkeit nachweisen muss, Primärpackmittel für Arzneimittel zu liefern, die stets den Anforderungen der Kunden, inklusive der gesetzlichen Bestimmungen und anwendbaren Internationalen Normen, entsprechen.
In diesem Dokument wird mehrfach der Begriff „falls angemessen“ verwendet. Wenn eine Anforderung auf diese Weise bezeichnet wird, wird sie als „angemessen“ betrachtet, solange die Organisation nicht eine anderweitige Begründung dokumentieren kann.
Dieses Dokument ist eine Anwendungsnorm für die Entwicklung, Herstellung und Lieferung von Primärpackmitteln für Arzneimittel.
Articles d'emballage primaire pour médicaments - Exigences particulières pour l'application de l'ISO 9001:2015 prenant en considération les Bonnes Pratiques de Fabrication (BPF) (ISO 15378:2017)
L'ISO 15378 :2017 spécifie les exigences relatives au système de management de la qualité lorsqu'un organisme:
a) doit démontrer son aptitude à fournir constamment des produits et des services conformes aux exigences des clients et aux exigences légales et réglementaires applicables, et
b) vise à accroître la satisfaction de ses clients par l'application efficace du système, y compris les processus pour l'amélioration du système et l'assurance de la conformité aux exigences des clients et aux exigences légales et réglementaires applicables.
Toutes les exigences de l'ISO 15378 :2017 sont génériques et prévues pour s'appliquer à tout organisme, quels que soient son type ou sa taille, ou les produits et services qu'il fournit.
NOTE 1 Dans l'ISO 15378 :2017, les termes «produit» ou «service» s'appliquent uniquement aux produits et services destinés à, ou exigés par, un client.
NOTE 2 L'expression «legal requirement» recouvre en anglais le concept, utilisé dans l'ISO 15378 :2017, d'exigence légale et réglementaire.
En complément de l'ISO 9001, le présent document spécifie les exigences des Bonnes Pratiques de Fabrication (BPF) applicables aux articles d'emballage primaire pour un système de management de la qualité lorsqu'un organisme doit démontrer son aptitude à fournir des articles d'emballage primaire pour médicaments satisfaisant en permanence aux exigences des clients, y compris les exigences réglementaires et les Normes internationales.
Dans le présent document, l'expression «si approprié» est utilisée plusieurs fois. Lorsqu'une exigence est qualifiée par cette expression, elle est réputée «appropriée» à moins que l'organisme ne puisse documenter une justification contraire.
Le présent document est une norme d'application destinée à la conception, à la fabrication et à la fourniture d'articles d'emballage primaire pour médicaments.
Primarni embalažni materiali za zdravila - Posebne zahteve za uporabo ISO 9001:2015 v povezavi z dobro proizvodno prakso (DPP) (ISO 15378:2017)
Ta dokument, poleg standarda ISO 9001, določa zahteve za dobro proizvodno prakso, ki se uporabljajo za primarne embalažne materiale v sistemu vodenja kakovosti v primerih, ko mora organizacija izkazati svojo zmožnost dobave primarnih embalažnih materialov za zdravila, ki dosledno izpolnjujejo zahteve strank ter zakonodajne zahteve.
V tem dokumentu je večkrat uporabljen izraz »če je primerno«. Kadar je v zahtevi dodana fraza »če je primerno«, se šteje, da je zahtevo treba upoštevati, razen če lahko organizacija dokumentira drugo utemeljitev.
Ta dokument je aplikacijski standard za načrtovanje, izdelavo in dobavo primarnih embalažnih materialov za zdravila.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-januar-2018
1DGRPHãþD
SIST EN ISO 15378:2015
Primarni embalažni materiali za zdravila - Posebne zahteve za uporabo ISO
9001:2015 v povezavi z dobro proizvodno prakso (DPP) (ISO 15378:2017)
Primary packaging materials for medicinal products - Particular requirements for the
application of ISO 9001:2015, with reference to good manufacturing practice (GMP) (ISO
15378:2017)
Primärpackmittel für Arzneimittel - Besondere Anforderungen für die Anwendung von
ISO 9001:2015 entsprechend der Guten Herstellungspraxis (GMP) (ISO 15378:2017)
Articles d'emballage primaire pour médicaments - Exigences particulières pour
l'application de l'ISO 9001:2015 prenant en considération les Bonnes Pratiques de
Fabrication (BPF) (ISO 15378:2017)
Ta slovenski standard je istoveten z: EN ISO 15378:2017
ICS:
03.120.10 Vodenje in zagotavljanje Quality management and
kakovosti quality assurance
11.040.01 Medicinska oprema na Medical equipment in general
splošno
55.040 0DWHULDOLLQSULSRPRþNL]D Packaging materials and
SDNLUDQMH accessories
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EN ISO 15378
EUROPEAN STANDARD
NORME EUROPÉENNE
October 2017
EUROPÄISCHE NORM
ICS 03.100.70; 11.040.01 Supersedes EN ISO 15378:2015
English Version
Primary packaging materials for medicinal products -
Particular requirements for the application of ISO
9001:2015, with reference to good manufacturing practice
(GMP) (ISO 15378:2017)
Articles d'emballage primaire pour médicaments - Primärpackmittel für Arzneimittel - Besondere
Exigences particulières pour l'application de l'ISO Anforderungen für die Anwendung von ISO 9001:2015
9001:2015 prenant en considération les Bonnes entsprechend der Guten Herstellungspraxis (GMP)
Pratiques de Fabrication (BPF) (ISO 15378:2017) (ISO 15378:2017)
This European Standard was approved by CEN on 13 October 2017.
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this
European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references
concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN
member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by
translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management
Centre has the same status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2017 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 15378:2017 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
European foreword
This document (EN ISO 15378:2017) has been prepared by Technical Committee ISO/TC 76
“Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical
use”.
This European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by April 2018, and conflicting national standards shall be
withdrawn at the latest by April 2018.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 15378:2015.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta,
Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.
Endorsement notice
The text of ISO 15378:2017 has been approved by CEN as EN ISO 15378:2017 without any modification.
INTERNATIONAL ISO
STANDARD 15378
Fourth edition
2017-09
Primary packaging materials for
medicinal products — Particular
requirements for the application of
ISO 9001:2015, with reference to good
manufacturing practice (GMP)
Articles d'emballage primaire pour médicaments — Exigences
particulières pour l'application de l'ISO 9001:2015 prenant en
considération les bonnes pratiques de fabrication (BPF)
Reference number
ISO 15378:2017(E)
©
ISO 2017
ISO 15378:2017(E)
© ISO 2017, Published in Switzerland
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form
or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior
written permission. Permission can be requested from either ISO at the address below or ISO’s member body in the country of
the requester.
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Tel. +41 22 749 01 11
Fax +41 22 749 09 47
copyright@iso.org
www.iso.org
ii © ISO 2017 – All rights reserved
ISO 15378:2017(E)
Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
3.1 Terms related to organization. 2
3.2 Terms related to activity . 3
3.3 Terms related to system . 4
3.4 Terms related to requirement . 5
3.5 Terms related to process . 6
3.6 Terms related to results . 7
3.7 Terms related to data, information and document . 8
3.8 Terms related to action . 9
3.9 Terms related to characteristic .10
3.10 Terms related to determination .10
3.11 Terms relating to risk management .11
4 Context of the organization .12
4.1 Understanding the organization and its context .12
4.2 Understanding the needs and expectations of interested parties .12
4.3 Determining the scope of the quality management system .13
4.4 Quality management system and its processes .13
5 Leadership .14
5.1 Leadership and commitment .14
5.1.1 General.14
5.1.2 Customer focus .15
5.1.3 Customer audits.15
5.2 P olicy .15
5.3 Organizational roles, responsibilities and authorities.16
6 Planning .17
6.1 Actions to address risks and opportunities .17
6.2 Quality objectives and planning to achieve them .18
6.3 Planning of changes .19
7 Support .19
7.1 Resources .19
7.1.1 General.19
7.1.2 People .19
7.1.3 Infrastructure .20
7.1.4 Environment for the operation of processes .21
7.1.5 Monitoring and measuring resources .23
7.1.6 Organizational knowledge .24
7.2 Competence .24
7.2.1 General.24
7.2.2 GMP-training .24
7.3 Awareness .25
7.4 Communication .25
7.5 Documented information .26
7.5.1 General.26
7.5.2 Creating and updating .26
7.5.3 Control of documented information .27
7.5.4 Administration of IT systems and data.28
8 Operation .29
ISO 15378:2017(E)
8.1 Operational planning and control .29
8.2 Requirements for products and services .30
8.2.1 Customer communication .30
8.2.2 Determining the requirements for products and services .31
8.2.3 Review of the requirements for products and services .31
8.2.4 Changes to requirements for products and services .32
8.3 Design and development of products and services .32
8.3.1 General.32
8.3.2 Design and development planning .32
8.3.3 Design and development inputs .33
8.3.4 Design and development controls .33
8.3.5 Design and development outputs .34
8.3.6 Design and development changes . .34
8.4 Control of externally provided processes, products and services .35
8.4.1 General.35
8.4.2 Type and extent of control .36
8.4.3 Information for external providers .37
8.5 Production and service provision .38
8.5.1 Control of production and service provision .38
8.5.2 Identification and traceability .41
8.5.3 Property belonging to customers or external providers .42
8.5.4 Preservation .42
8.5.5 Post-delivery activities .43
8.5.6 Control of changes .43
8.6 Release of products and services .44
8.7 Control of nonconforming outputs .44
9 Performance evaluation .45
9.1 Monit oring, measurement, analysis and evaluation .45
9.1.1 General.45
9.1.2 Customer satisfaction .45
9.1.3 Analysis and evaluation .46
9.2 Internal audit .48
9.3 Management review .48
9.3.1 General.48
9.3.2 Management review inputs .49
9.3.3 Management review outputs .49
10 Improvement .50
10.1 General .50
10.2 Nonconformity and corrective action .50
10.3 Continual improvement .51
Annex A (informative) Clarification of new structure, terminology and concepts .52
Annex B (informative) Other International Standards on quality management and quality
management systems developed by ISO/TC 176 .56
Annex C (normative) GMP requirements for printed primary packaging materials .60
Annex D (informative) Guidance on verification, qualification and validation requirements
for primary packaging materials .64
Bibliography .75
Alphabetical index of defined terms used in this document .78
iv © ISO 2017 – All rights reserved
ISO 15378:2017(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
through ISO technical committees. Each member body interested in a subject for which a technical
committee has been established has the right to be represented on that committee. International
organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.
ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www.iso.org/patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation on the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to the
World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see the following
URL: www.iso.org/iso/foreword.html.
This document was prepared by ISO/TC 76, Transfusion, infusion and injection, and blood processing
equipment for medical and pharmaceutical use.
This fourth edition cancels and replaces the third edition (ISO 15378:2015), which has been technically
revised. The main technical and editorial changes comprise:
— the integration of the sector-specific requirements on quality management systems for medicinal
products into ISO 9001:2015;
— the deletion of the requirements on quality manual;
— the inclusion of all annexes of ISO 9001:2015 into this document;
— adjustments to the terminology of ISO 9000:2015, where relevant;
— the inclusion of an alphabetical index of defined terms used in this document.
ISO 15378:2017(E)
Introduction
0.1 General
This document identifies Good Manufacturing Practice (GMP) principles and specifies requirements
for a quality management system applicable to primary packaging materials for medicinal products.
The realization of GMP principles in production and control of primary packaging materials within
organizations is of great importance for the safety of a patient using the medicinal product, because
of their direct product contact. The application of GMP for pharmaceutical packaging materials helps
ensure that these materials meet the needs and requirements of the pharmaceutical industry.
This document is an application standard for primary packaging materials, which contains the text of
ISO 9001:2015.
The conventions for the layout of this document are the following.
— Those clauses, subclauses or annexes that are quoted directly and unchanged from ISO 9001:2015
and ISO 9000:2015 (under Clause 3) are in boxes.
— Additional GMP related requirements and recommendations as well as terms and definitions
relevant to the manufacture of primary packaging materials are outside boxes.
ISO 9001:2015, Quality management systems — Requirements
0.1 General
The adoption of a quality management system is a strategic decision for an organization that can
help to improve its overall performance and provide a sound basis for sustainable development
initiatives.
The potential benefits to an organization of implementing a quality management system based on
this International Standard are:
a) the ability to consistently provide products and services that meet customer and applicable
statutory and regulatory requirements;
b) facilitating opportunities to enhance customer satisfaction;
c) addressing risks and opportunities associated with its context and objectives;
d) the ability to demonstrate conformity to specified quality management system requirements.
This International Standard can be used by internal and external parties.
It is not the intent of this International Standard to imply the need for:
— uniformity in the structure of different quality management systems;
— alignment of documentation to the clause structure of this International Standard;
— the use of the specific terminology of this International Standard within the organization.
The quality management system requirements specified in this International Standard are
complementary to requirements for products and services.
This International Standard employs the process approach, which incorporates the Plan-Do-Check-
Act (PDCA) cycle and risk-based thinking.
vi © ISO 2017 – All rights reserved
ISO 15378:2017(E)
The process approach enables an organization to plan its processes and their interactions.
The PDCA cycle enables an organization to ensure that its processes are adequately resourced and
managed, and that opportunities for improvement are determined and acted on.
Risk-based thinking enables an organization to determine the factors that could cause its processes
and its quality management system to deviate from the planned results, to put in place preventive
controls to minimize negative effects and to make maximum use of opportunities as they arise (see
Clause A.4).
Consistently meeting requirements and addressing future needs and expectations poses a challenge
for organizations in an increasingly dynamic and complex environment. To achieve this objective, the
organization might find it necessary to adopt various forms of improvement in addition to correction
and continual improvement, such as breakthrough change, innovation and re-organization.
In this International Standard, the following verbal forms are used:
— “shall” indicates a requirement;
— “should” indicates a recommendation;
— “may” indicates a permission;
— “can” indicates a possibility or a capability.
Information marked as “NOTE” is for guidance in understanding or clarifying the associated
requirement.
A key objective of this document is to specify GMP for primary packaging materials.
0.2 Quality management principles
ISO 9001:2015, Quality management systems — Requirements
0.2 Quality management principles
This International Standard is based on the quality management principles described in ISO 9000.
The descriptions include a statement of each principle, a rationale of why the principle is important
for the organization, some examples of benefits associated with the principle and examples of typical
actions to improve the organization's performance when applying the principle.
The quality management principles are:
— customer focus;
— leadership;
— engagement of people;
— process approach;
— improvement;
— evidence-based decision making;
— relationship management.
ISO 15378:2017(E)
0.3 Process approach
0.3.1 General
ISO 9001:2015, Quality management systems — Requirements
0.3 Process approach
0.3.1 General
This International Standard promotes the adoption of a process approach when developing, imple-
menting and improving the effectiveness of a quality management system, to enhance customer
satisfaction by meeting customer requirements. Specific requirements considered essential to the
adoption of a process approach are included in 4.4.
Understanding and managing interrelated processes as a system contributes to the organization's
effectiveness and efficiency in achieving its intended results. This approach enables the organization
to control the interrelationships and interdependencies among the processes of the system, so that
the overall performance of the organization can be enhanced.
The process approach involves the systematic definition and management of processes, and their in-
teractions, so as to achieve the intended results in accordance with the quality policy and strategic di-
rection of the organization. Management of the processes and the system as a whole can be achieved
using the PDCA cycle (see 0.3.2) with an overall focus on risk-based thinking (see 0.3.3) aimed at
taking advantage of opportunities and preventing undesirable results.
The application of the process approach in a quality management system enables:
a) understanding and consistency in meeting requirements;
b) the consideration of processes in terms of added value;
c) the achievement of effective process performance;
d) improvement of processes based on evaluation of data and information.
Figure 1 gives a schematic representation of any process and shows the interaction of its elements.
The monitoring and measuring check points, which are necessary for control, are specific to each
process and will vary depending on the related risks.
Figure 1 — Schematic representation of the elements of a single process
viii © ISO 2017 – All rights reserved
ISO 15378:2017(E)
0.3.2 Plan-Do-Check-Act cycle
ISO 9001:2015, Quality management systems — Requirements
0.3.2 Plan-Do-Check-Act cycle
The PDCA cycle can be applied to all processes and to the quality management system as a whole.
Figure 2 illustrates how Clauses 4 to 10 can be grouped in relation to the PDCA cycle.
NOTE Numbers in brackets refer to the clauses in this International Standard.
Figure 2 — Representation of the structure of this International Standard in the PDCA cycle
The PDCA cycle can be briefly described as follows:
— Plan: establish the objectives of the system and its processes, and the resources needed to deliver
results in accordance with customers' requirements and the organization's policies, and identify
and address risks and opportunities;
— Do: implement what was planned;
— Check: monitor and (where applicable) measure processes and the resulting products and
services against policies, objectives, requirements and planned activities, and report the results;
— Act: take actions to improve performance, as necessary.
ISO 15378:2017(E)
0.3.3 Risk-based thinking
ISO 9001:2015, Quality management systems — Requirements
0.3.3 Risk-based thinking
Risk-based thinking (see Clause A.4) is essential for achieving an effective quality management
system. The concept of risk-based thinking has been implicit in previous editions of this
International Standard including, for example, carrying out preventive action to eliminate potential
nonconformities, analysing any nonconformities that do occur, and taking action to prevent
recurrence that is appropriate for the effects of the nonconformity.
To conform to the requirements of this International Standard, an organization needs to plan and
implement actions to address risks and opportunities. Addressing both risks and opportunities
establishes a basis for increasing the effectiveness of the quality management system, achieving
improved results and preventing negative effects.
Opportunities can arise as a result of a situation favourable to achieving an intended result, for
example, a set of circumstances that allow the organization to attract customers, develop new
products and services, reduce waste or improve productivity. Actions to address opportunities
can also include consideration of associated risks. Risk is the effect of uncertainty and any such
uncertainty can have positive or negative effects. A positive deviation arising from a risk can provide
an opportunity, but not all positive effects of risk result in opportunities.
Because of the nature of primary packaging materials the risk-based approach is applied throughout all
processes of the organization.
x © ISO 2017 – All rights reserved
ISO 15378:2017(E)
0.4 Relationship with other management system standards
This document incorporates the requirements of ISO 9001:2015 and, additionally, particular
requirements for primary packaging materials, which are derived and adapted, as appropriate, from
GMP for the production and control of medicinal products.
ISO 9001:2015, Quality management systems — Requirements
0.4 Relationship with other management system standards
This International Standard applies the framework developed by ISO to improve alignment among
its International Standards for management systems (see Clause A.1).
This International Standard enables an organization to use the process approach, coupled with the
PDCA cycle and risk-based thinking, to align or integrate its quality management system with the
requirements of other management system standards.
This International Standard relates to ISO 9000 and ISO 9004 as follows:
— ISO 9000 Quality management systems — Fundamentals and vocabulary provides essential
background for the proper understanding and implementation of this International Standard;
— ISO 9004 Managing for the sustained success of an organization — A quality management approach
provides guidance for organizations that choose to progress beyond the requirements of this
International Standard.
Annex B provides details of other International Standards on quality management and quality
management systems that have been developed by ISO/TC 176.
This International Standard does not include requirements specific to other management systems,
such as those for environmental management, occupational health and safety management, or
financial management.
Sector-specific quality management system standards based on the requirements of this
International Standard have been developed for a number of sectors. Some of these standards specify
additional quality management system requirements, while others are limited to providing guidance
to the application of this International Standard within the particular sector.
A matrix showing the correlation between the clauses of this edition of this International Standard
and the previous edition (ISO 9001:2008) can be found on the ISO/TC 176/SC 2 open access website
at: www.iso.org/tc176/sc02/public.
INTERNATIONAL STANDARD ISO 15378:2017(E)
Primary packaging materials for medicinal products —
Particular requirements for the application of ISO
9001:2015, with reference to good manufacturing
practice (GMP)
1 Scope
ISO 9001:2015, Quality management systems — Requirements
1 Scope
This International Standard specifies requirements for a quality management system when an
organization:
a) needs to demonstrate its ability to consistently provide products and services that meet
customer and applicable statutory and regulatory requirements, and
b) aims to enhance customer satisfaction through the effective application of the system, including
processes for improvement of the system and the assurance of conformity to customer and
applicable statutory and regulatory requirements.
All the requirements of this International Standard are generic and are intended to be applicable to
any organization, regardless of its type or size, or the products and services it provides.
NOTE 1 In this International Standard, the terms “product” or “service” only apply to products and services
intended for, or required by, a customer.
NOTE 2 Statutory and regulatory requirements can be expressed as legal requirements.
In addition to ISO 9001, this document specifies Good Manufacturing Practice (GMP) requirements
applicable to primary packaging materials for a quality management system where an organization
needs to demonstrate its ability to provide primary packaging materials for medicinal products,
which consistently meet customer requirements, including regulatory requirements and International
Standards.
In this document the term “if appropriate” is used several times. When a requirement is qualified by this
phrase, it is deemed to be “appropriate” unless the organization can document a justification otherwise.
This document is an application standard for the design, manufacture and supply of primary packaging
materials for medicinal products.
2 Normative references
ISO 9001:2015, Quality management systems — Requirements
2 Normative references
The following documents, in whole or in part, are normatively referenced in this document and are
indispensable for its application. For dated references, only the edition cited applies. For undated
references, the latest edition of the referenced document (including any amendments) applies.
ISO 9000:2015, Quality management systems — Fundamentals and vocabulary
ISO 15378:2017(E)
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments) applies.
ISO 14698-1, Cleanrooms and associated controlled environments — Biocontamination control — Part 1:
General principles and methods
ISO 14698-2, Cleanrooms and associated controlled environments — Biocontamination control — Part 2:
Evaluation and interpretation of biocontamination data
3 Terms and definitions
ISO 9001:2015, Quality management systems — Requirements
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 9000:2015 apply.
For the purposes of this document, the terms and definitions given in ISO 9000:2015 and the
following apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at http://www.iso.org/obp
— IEC Electropedia: available at http://www.electropedia.org/
NOTE 1 This document only duplicates terms and definitions of ISO 9000:2015 when they have been amended
in order to address the specific needs of this document.
NOTE 2 The structure of terms and definitions in this document corresponds to that used in ISO 9000:2015,
as far as applicable. An additional heading “Terms related to risk management” has been added in this document.
NOTE 3 An index of defined terms is found at the end of this document.
3.1 Terms related to organization
3.1.1
organization
person or group of people that has its own functions with responsibilities, authorities and relationships
to achieve its objectives
Note 1 to entry: The concept of organization includes, but is not limited to sole-trader, company, corporation,
firm, enterprise, authority, partnership, association, charity or institution, or part or combination thereof,
whether incorporated or not, public or private.
Note 2 to entry: In this document the organization is the company manufacturing the primary packaging material
(3.6.4).
[SOURCE: ISO 9000:2015, 3.2.1, modified by deleting Note 2 to entry and adding a new Note 2 to entry]
3.1.2
quality unit
organizational unit which fulfils both quality assurance (QA) and quality control (QC) responsibilities
Note 1 to entry: The quality unit(s) can consist of separate QA and QC units or of a single individual (or group),
depending upon the size and structure of the organization (3.1.1).
2 © ISO 2017 – All rights reserv
...
ba
S L O V E N S K I SIST EN ISO 15378
S T A N D A R D
januar 2018
Primarni embalažni materiali za zdravila – Posebne zahteve za uporabo
ISO 9001:2015 v povezavi z dobro proizvodno prakso (DPP) (ISO 5378:2017)
Primary packaging materials for medicinal products – Particular requirements for
the application of ISO 9001:2015, with reference to good manufacturing practice
(DPP) (ISO 15378:2017)
Articles d'emballage primaire pour médicaments - Exigences particulières pour
l'application de l'ISO 9001:2015 prenant en considération les Bonnes Pratiques de
Fabrication (BPF) (ISO 15378:2017)
Primärpackmittel für Arzneimittel – Besondere Anforderungen für die Anwendung
von ISO 9001:2015 entsprechend der Guten Herstellungspraxis (DPP)
(ISO 15378:2017)
Referenčna oznaka
ICS 03.120.10; 11.040.01; 55.040 SIST EN ISO 15378:2018 (sl)
Nadaljevanje na straneh II in III ter od 1 do 132
© 2023-04. Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
SIST EN ISO 15378 : 2018
NACIONALNI UVOD
Standard SIST EN ISO 15378 (sl, en), Primarni embalažni materiali za zdravila – Posebne zahteve za
uporabo ISO 9001:2015 v povezavi z dobro proizvodno prakso (DPP) (ISO 15378:2017), 2018, ima
status slovenskega standarda in je istoveten evropskemu standardu EN ISO 15378 (en), Primary
packaging materials for medicinal products – Particular requirements for the application of ISO
9001:2015, with reference to good manufacturing practice (GMP) (ISO 15378:2017), 2017.
Ta standard nadomešča SIST EN ISO 15378:2015
NACIONALNI PREDGOVOR
Evropski standard EN ISO 15378:2017 je pripravil tehnični odbor ISO/TC 76 Transfuzijski, infuzijski in
injekcijski pripomočki ter oprema za obdelavo krvi za uporabo v medicini in farmaciji. Slovenski standard
V primeru spora glede besedila slovenskega prevoda v tem standardu je odločilen izvirni evropski
standard v angleškem jeziku. Slovensko-angleško izdajo standarda je pripravil SIST/TC VZK Vodenje
in zagotavljanje kakovosti.
Odločitev za privzem tega standarda je 26. oktobra 2017 sprejel tehnični odbor SIST/TC VZK Vodenje
in zagotavljanje kakovosti.
ZVEZA S STANDARDI
S privzemom tega evropskega standarda veljajo za omejeni namen referenčnih standardov vsi
standardi, navedeni v izvirniku, razen standarda, ki smo ga že sprejeli v nacionalno standardizacijo:
SIST EN ISO 9000:2015 (sl, en) Sistemi vodenja kakovosti – Osnove in slovar (ISO 9000:2015)
SIST EN ISO 9001:2015 (sl, en) Sistemi vodenja kakovosti – Zahteve (ISO 9001:2015)
SIST EN ISO 9004:2018 (sl, en) Vodenje kakovosti – Kakovost organizacije – Napotki za doseganje
trajne uspešnosti (ISO 9004:2018)
OSNOVA ZA IZDAJO STANDARDA
– privzem standarda EN ISO 15378:2017
PREDHODNA IZDAJA
– SIST EN ISO 15378:2015, Primarni embalažni materiali za zdravila – Posebne zahteve za uporabo
ISO 9001:2008 v povezavi z dobro proizvodno prakso (DPP) (ISO 15378:2015)
OPOMBE
Povsod, kjer se v besedilu standarda uporablja izraz ''evropski standard'' ali ''mednarodni
standard'', v SIST EN ISO 15378:2018 to pomeni ''slovenski standard''.
– Nacionalni uvod in nacionalni predgovor nista sestavni del standarda.
II
SIST EN 61140 : 2016
Ta nacionalni dokument je istoveten EN ISO 15378:2017 in je objavljen z dovoljenjem
CEN-CENELEC
Avenue Marnix 17
1000 Bruselj
Belgija
This national document is identical with EN ISO 15378:2017 and is published with the permission
of
CEN-CEMELEC
Avenue Marnix 17
1000 Bruxelles
Belgium
III
SIST EN ISO 15378 : 2018
(prazna stran)
IV
EVROPSKI STANDARD EN ISO 15378
EUROPEAN STANDARD
NORME EUROPÉENNE
oktober 2017
EUROPÄISCHE NORM
ICS 03.120.10; 11.040.01; 55.040 Nadomešča EN ISO 15378:2015
Slovenska izdaja
Primarni embalažni materiali za zdravila – Posebne zahteve za
uporabo ISO 9001:2015 v povezavi z dobro proizvodno prakso (DPP)
(ISO 15378:2017)
Primary packaging materials for Articles d'emballage primaire pour Primärpackmittel für Arzneimittel –
medicinal products – Particular médicaments – Exigences Besondere Anforderungen für die
requirements for the application of particulières pour l'application de Anwendung von ISO 9001:2015
ISO 9001:2015, with reference to l'ISO 9001:2015 prenant en entsprechend der Guten
good manufacturing practice considération les Bonnes Herstellungspraxis (DPP) (ISO
(DPP) (ISO 15378:2017) Pratiques de Fabrication (BPF) 15378:2017)
(ISO 15378:2017)
Ta evropski standard je CEN sprejel dne 13. oktobra 2017.
Člani CEN morajo izpolnjevati določila notranjih predpisov CEN/CENELEC, s katerimi je predpisano, da
mora biti ta standard brez kakršnihkoli sprememb sprejet kot nacionalni standard. Seznami najnovejših
izdaj teh nacionalnih standardov in njihovi bibliografski podatki so na zahtevo na voljo pri Upravnem
centru CEN-CENELEC ali članih CEN.
Ta evropski standard obstaja v treh uradnih izdajah (angleški, francoski in nemški). Izdaje v drugih
jezikih, ki jih člani CEN na lastno odgovornost prevedejo in izdajo ter prijavijo pri Upravnem centru CEN-
CENELEC, veljajo kot uradne izdaje.
Člani CEN so nacionalni organi za standarde Avstrije, Belgije, Bolgarije, Cipra, Češke republike,
Danske, Estonije, Finske, Francije, Grčije, Hrvaške, Irske, Islandije, Italije, Latvije, Litve, Luksemburga,
Madžarske, Malte, Nekdanje jugoslovanske republike Makedonije, Nemčije, Nizozemske, Norveške,
Poljske, Portugalske, Romunije, Slovaške, Slovenije, Srbije, Španije, Švedske, Švice, Turčije in
Združenega kraljestva.
CEN
Evropski komite za standardizacijo
European Committee for Standardization
Comité Européen de Normalisation
Europäisches Komitee für Normung
Upravni center CEN-CENELEC: Avenue Marnix 17, B-1000 Bruselj
© 2017 CEN Vse pravice do izkoriščanja v kakršnikoli obliki in na kakršenkoli Ref. št. EN ISO 15378:2017 E
način imajo nacionalni člani CEN.
SIST EN ISO 15378 : 2018
Evropski predgovor European foreword
Ta dokument (EN ISO 15378:2017) je pripravil This document (EN ISO 15378:2017) has
tehnični odbor ISO/TC 76 "Transfuzijski, been prepared by Technical Committee
infuzijski in injekcijski pripomočki ter oprema ISO/TC 76 “Transfusion, infusion and
za obdelavo krvi za uporabo v medicini in injection, and blood processing equipment for
farmaciji". medical and pharmaceutical use”.
Ta evropski standard mora z objavo This European Standard shall be given the
istovetnega besedila ali z razglasitvijo dobiti status of a national standard, either by
status nacionalnega standarda najpozneje do publication of an identical text or by
aprila 2018, nacionalne standarde, ki so v endorsement, at the latest by April 2018, and
nasprotju s tem standardom, pa je treba conflicting national standards shall be
umakniti najpozneje do aprila 2018. withdrawn at the latest by April 2018.
Opozoriti je treba na možnost, da je nekaj Attention is drawn to the possibility that some
elementov tega dokumenta lahko predmet of the elements of this document may be the
patentnih pravic. CEN ne prevzema subject of patent rights. CEN shall not be held
odgovornosti za identifikacijo katerihkoli ali responsible for identifying any or all such
vseh takih patentnih pravic. patent rights.
Ta dokument nadomešča standard EN ISO This document supersedes EN ISO
15378:2015. 15378:2015.
V skladu z notranjimi pravili CEN-CENELEC According to the CEN-CENELEC Internal
morajo ta evropski standard prevzeti Regulations, the national standards
nacionalne organizacije za standarde organizations of the following countries are
naslednjih držav: Avstrije, Belgije, Bolgarije, bound to implement this European Standard:
Cipra, Češke republike, Danske, Estonije, Austria, Belgium, Bulgaria, Croatia, Cyprus,
Finske, Francije, Grčije, Hrvaške, Irske, Czech Republic, Denmark, Estonia, Finland,
Islandije, Italije, Latvije, Litve, Luksemburga, Former Yugoslav Republic of Macedonia,
Madžarske, Malte, Nekdanje jugoslovanske France, Germany, Greece, Hungary, Iceland,
republike Makedonije, Nemčije, Nizozemske, Ireland, Italy, Latvia, Lithuania, Luxembourg,
Norveške, Poljske, Portugalske, Romunije, Malta, Netherlands, Norway, Poland,
Slovaške, Slovenije, Srbije, Španije, Švedske, Portugal, Romania, Serbia, Slovakia,
Švice, Turčije in Združenega kraljestva. Slovenia, Spain, Sweden, Switzerland, Turkey
and the United Kingdom.
Razglasitvena objava Endorsement notice
Besedilo mednarodnega standarda ISO The text of ISO 15378:2017 has been
15378:2017 je CEN odobril kot evropski approved by CEN as EN ISO 15378:2017
standard EN ISO 15378:2017 brez without any modification.
kakršnihkoli sprememb.
SIST EN ISO 15378 : 2018
VSEBINA Stran CONTENTS Page
Evropski predgovor . 2 European foreword . 2
Predgovor . 6 Foreword . . 6
Uvod . 8 Introduction . 8
1 Področje uporabe . 18 1 Scope .18
2 Zveze s standardi . 19 2 Normative references .19
3 Izrazi in definicije . 19 3 Terms and definitions .19
3.1 Izrazi v zvezi z organizacijo . 20 3.1 Terms related to organization .20
3.2 Izrazi v zvezi z aktivnostjo . 21 3.2 Terms related to activity .21
3.3 Izrazi v zvezi s sistemom . 23 3.3 Terms related to system .23
3.4 Izrazi v zvezi z zahtevami . 24 3.4 Terms related to requirement .24
3.5 Izrazi v zvezi s procesi . 25 3.5 Terms related to process .25
3.6 Izrazi v zvezi z rezultati . 27 3.6 Terms related to results .27
3.7 Izrazi v zvezi s podatki, informacijami in 3.7 Terms related to data, information and
dokumenti . 28 document .28
3.8 Izrazi v zvezi z ukrepi . 30 3.8 Terms related to action .30
3.9 Izrazi v zvezi s karakteristikami . 31 3.9 Terms related to characteristic .31
3.10 Izrazi v zvezi z opredeljevanjem . 31 3.10 Terms related to determination .31
3.11 Izrazi v zvezi z obvladovanjem 3.11 Terms relating to risk management .32
tveganja . 32
4 Kontekst organizacije . 33 4 Context of the organization .33
4.1 Razumevanje organizacije in njenega 4.1 Understanding the organization and its
konteksta . 33 context .33
4.2 Razumevanje potreb in pričakovanj 4.2 Understanding the needs and expectations
zainteresiranih strani . 34 of interested parties .34
4.3 Opredeljevanje področja uporabe sistema 4.3 Determining the scope of the quality
vodenja kakovosti . 34 management system .34
4.4 Sistem vodenja kakovosti in njegovi 4.4 Quality management system and its
procesi . 35 processes .35
5 Voditeljstvo . 36 5 Leadership .36
5.1 Voditeljstvo in zavezanost . 36 5.1 Leadership and commitment .36
5.1.1 Splošno . 36 5.1.1 General .36
5.1.2 Osredotočenost na odjemalce . 37 5.1.2 Customer focus .37
5.1.3 Presoje odjemalcev . 38 5.1.3 Customer audits .38
5.2 Politika . 38 5.2 Policy .38
5.3 Vloge, odgovornosti in pooblastila 5.3 Organizational roles, responsibilities and
organizacije . 39 authorities .39
6 Planiranje . 40 6 Planning .40
6.1 Ukrepi za obravnavanje tveganj in 6.1 Actions to address risks and
priložnosti . 40 opportunities .40
6.2 Cilji kakovosti in planiranje za njihovo 6.2 Quality objectives and planning to
doseganje . 41 achieve them .41
6.3 Planiranje sprememb . 42 6.3 Planning of changes .42
SIST EN ISO 15378 : 2018
7 Podpora . 43 7 Support .43
7.1 Viri . 43 7.1 Resources .43
7.1.1 Splošno . 43 7.1.1 General .43
7.1.2 Ljudje . 43 7.1.2 People .43
7.1.3 Infrastruktura . 43 7.1.3 Infrastructure .43
7.1.4 Okolje za delovanje procesov . 44 7.1.4 Environment for the operation of
processes .44
7.1.5 Viri nadzorovanja in merjenja . 48 7.1.5 Monitoring and measuring resources .48
7.1.6 Znanje organizacije . 49 7.1.6 Organizational knowledge .49
7.2 Kompetentnost . 49 7.2 Competence .49
7.2.1 Splošno . 49 7.2.1 General .49
7.2.2 Usposabljanje s področja DPP . 50 7.2.2 GMP-training .50
7.3 Ozaveščenost . 51 7.3 Awareness .51
7.4 Komuniciranje . 51 7.4 Communication .51
7.5 Dokumentirane informacije . 52 7.5 Documented information .52
7.5.1 Splošno . 52 7.5.1 General .52
7.5.2 Ustvarjanje in posodabljanje . 52 7.5.2 Creating and updating .52
7.5.3 Obvladovanje dokumentiranih 7.5.3 Control of documented information .53
informacij . 53
7.5.4 Upravljanje informacijskih sistemov in 7.5.4 Administration of IT systems and
podatkov . 55 data .55
8 Delovanje . 56 8 Operation .56
8.1 Planiranje in obvladovanje delovanja . 56 8.1 Operational planning and control .56
8.2 Zahteve za izdelke in storitve . 57 8.2 Requirements for products and services .57
8.2.1 Komuniciranje z odjemalci . 57 8.2.1 Customer communication .57
8.2.2 Opredeljevanje zahtev za izdelke in 8.2.2 Determining the requirements for
storitve . 58 products and services .58
8.2.3 Pregled zahtev za izdelke in storitve . 59 8.2.3 Review of the requirements for products
and services .59
8.2.4 Spremembe zahtev za izdelke in 8.2.4 Changes to requirements for products
storitve . 60 and services .60
8.3 Snovanje in razvoj izdelkov in storitev . 60 8.3 Design and development of products and
services .60
8.3.1 Splošno . 60 8.3.1 General .60
8.3.2 Planiranje snovanja in razvoja . 60 8.3.2 Design and development planning .60
8.3.3 Vhodi snovanja in razvoja . 61 8.3.3 Design and development inputs .61
8.3.4 Ukrepi za obvladovanje snovanja in 8.3.4 Design and development controls .62
razvoja . 62
8.3.5 Izhodi snovanja in razvoja . 63 8.3.5 Design and development outputs .63
8.3.6 Spremembe snovanja in razvoja . 63 8.3.6 Design and development changes .63
8.4 Obvladovanje procesov, izdelkov in 8.4 Control of externally provided
storitev zunanjih ponudnikov . 64 processes, products and services .64
8.4.1 Splošno . 64 8.4.1 General .64
SIST EN ISO 15378 : 2018
8.4.2 Vrsta in obseg obvladovanja . 65 8.4.2 Type and extent of control .65
8.4.3 Informacije za zunanje ponudnike . 67 8.4.3 Information for external providers .67
8.5 Proizvodnja in izvedba storitev . 68 8.5 Production and service provision .68
8.5.1 Obvladovanje proizvodnje in izvedbe 8.5.1 Control of production and service
storitev . 68 provision .38
8.5.2 Identifikacija in sledljivost . 73 8.5.2 Identification and traceability .73
8.5.3 Lastnina odjemalcev in zunanjih 8.5.3 Property belonging to customers or
ponudnikov . 74 external providers .74
8.5.4 Ohranitev . 75 8.5.4 Preservation .75
8.5.5 Aktivnosti po dostavi . 76 8.5.5 Post-delivery activities .76
8.5.6 Obvladovanje sprememb . 76 8.5.6 Control of changes .76
8.6 Sprostitev izdelkov in storitev . 77 8.6 Release of products and services .77
8.7 Obvladovanje neskladnih izhodov . 78 8.7 Control of nonconforming outputs .78
9 Vrednotenje izvedbe . 79 9 Performance evaluation .79
9.1 Nadzorovanje, merjenje, analiziranje in 9.1 Monitoring, measurement, analysis and
vrednotenje . 79 evaluation .79
9.1.1 Splošno . 79 9.1.1 General .79
9.1.2 Zadovoljstvo odjemalcev . 79 9.1.2 Customer satisfaction .79
9.1.3 Analiziranje in vrednotenje . 80 9.1.3 Analysis and evaluation .80
9.2 Notranja presoja . 82 9.2 Internal audit .82
9.3 Vodstveni pregled . 83 9.3 Management review .83
9.3.1 Splošno . 83 9.3.1 General .83
9.3.2 Vhodi vodstvenega pregleda . 83 9.3.2 Management review inputs .83
9.3.3 Izhodi vodstvenega pregleda . 84 9.3.3 Management review outputs .84
10 Izboljševanje . 84 10 Improvement .84
10.1 Splošno . 84 10.1 General .84
10.2 Neskladnost in korektivni ukrepi . 85 10.2 Nonconformity and corrective action .85
10.3 Nenehno izboljševanje . 87 10.3 Continual improvement .87
Dodatek A (informativni): Pojasnilo o novi Annex A (informative) Clarification of new
strukturi, terminologiji in pojmih . 88 structure, terminology and concepts .88
Dodatek B (informativni): Drugi mednarodni Annex B (informative) Other International
standardi o vodenju kakovosti in sistemih Standards on quality management and
vodenja kakovosti, ki jih je razvil quality management systems developed
ISO/TC 176 . 94 by ISO/TC 176 .94
Dodatek C (normativni): Zahteve dobre Annex C (normative) GMP requirements
proizvodne prakse za tiskane primarne for printed primary packaging
embalažne materiale . 101 materials .101
Dodatek D (informativni): Navodila za Annex D (informative) Guidance on
overjanje, kvalifikacijo in validacijo verification, qualification and validation
zahtev za primarne embalažne requirements for primary packaging
materiale . 107 materials .107
Literatura . 125 Bibliography .125
Abecedno kazalo opredeljenih izrazov, Alphabetical index of defined terms used in this
uporabljenih v tem dokumentu . 130 document .130
SIST EN ISO 15378 : 2018
Predgovor Foreword
Mednarodna organizacija za standardizacijo ISO (the International Organization for
(ISO) je svetovna zveza nacionalnih organov za Standardization) is a worldwide federation of
standarde (članov ISO). Mednarodne standarde national standards bodies (ISO member bodies).
praviloma pripravljajo tehnični odbori ISO. Vsak The work of preparing International Standards is
član, ki ga zanima področje, za katero je bil normally carried out through ISO technical
ustanovljen tehnični odbor, ima pravico biti committees. Each member body interested in a
zastopan v tem odboru. Pri delu sodelujejo tudi subject for which a technical committee has been
mednarodne vladne in nevladne organizacije, established has the right to be represented on that
povezane z ISO. V vseh zadevah, ki so committee. International organizations,
povezane s standardizacijo na področju governmental and non-governmental, in liaison
elektrotehnike, ISO tesno sodeluje z with ISO, also take part in the work. ISO
Mednarodno elektrotehniško komisijo (IEC). collaborates closely with the International
Electrotechnical Commission (IEC) on all matters
of electrotechnical standardization.
Postopki, uporabljeni pri razvoju tega The procedures used to develop this document
dokumenta, in postopki, predvideni za njegovo and those intended for its further maintenance are
nadaljnje vzdrževanje, so opisani v Direktivah described in the ISO/IEC Directives, Part 1. In
ISO/IEC, 1. del. Posebna pozornost naj se particular the different approval criteria needed for
nameni različnim kriterijem odobritve, potrebnim the different types of ISO documents should be
za različne vrste dokumentov ISO. Ta dokument noted. This document was drafted in accordance
je bil pripravljen v skladu z uredniškimi pravili with the editorial rules of the ISO/IEC Directives,
Direktiv ISO/IEC, 2. del (glej Part 2 (see www.iso.org/directives).
www.iso.org/directives).
Opozoriti je treba na možnost, da je nekaj Attention is drawn to the possibility that some of
elementov tega dokumenta lahko predmet the elements of this document may be the subject
patentnih pravic. ISO ne prevzema odgovornosti of patent rights. ISO shall not be held responsible
za identifikacijo katerihkoli ali vseh takih for identifying any or all such patent rights. Details
patentnih pravic. Podrobnosti o morebitnih of any patent rights identified during the
patentnih pravicah, identificiranih med pripravo development of the document will be in the
tega dokumenta, bodo navedene v uvodu in/ali Introduction and/or on the ISO list of patent
na seznamu patentnih izjav, ki jih je prejela
declarations received (see www.iso.org/patents).
organizacija ISO (glej www.iso.org/patents).
Morebitna trgovska imena, uporabljena v tem Any trade name used in this document is
dokumentu, so informacije za uporabnike in ne information given for the convenience of users
pomenijo podpore blagovni znamki. and does not constitute an endorsement.
Za razlago pomena specifičnih pojmov in izrazov For an explanation on the voluntary nature of
ISO, povezanih z ugotavljanjem skladnosti, ter standards, the meaning of ISO specific terms and
informacij o tem, kako ISO spoštuje načela expressions related to conformity assessment, as
Mednarodne trgovinske organizacije (WTO) v well as information about ISO's adherence to the
Tehničnih ovirah pri trgovanju (TBT), glej World Trade Organization (WTO) principles in the
naslednji naslov URL: Technical Barriers to Trade (TBT) see the
www.iso.org/foreword.html. following URL: www.iso.org/foreword.html.
Ta dokument je pripravil tehnični odbor ISO/TC This document was prepared by ISO/TC 76,
76 Transfuzijski, infuzijski in injekcijski Transfusion, infusion and injection, and blood
pripomočki ter oprema za obdelavo krvi za processing equipment for medical and
uporabo v medicini in farmaciji. pharmaceutical use.
Ta četrta izdaja standarda razveljavlja in This fourth edition cancels and replaces the third
nadomešča tretjo izdajo (ISO 15378:2015), ki je edition (ISO 15378:2015), which has been
bila tehnično revidirana. Glavne tehnične in technically revised. The main technical and
redakcijske spremembe zajemajo: editorial changes comprise:
SIST EN ISO 15378 : 2018
– vključitev sektorsko specifičnih zahtev o – the integration of the sector-specific
sistemih vodenja kakovosti za zdravila v requirements on quality management
standard ISO 9001:2015, systems for medicinal products into ISO
9001:2015;
– izbris zahtev o poslovniku kakovosti, – the deletion of the requirements on quality
manual;
– vključitev vseh dodatkov k ISO 9001:2015 v – the inclusion of all annexes of ISO
ta dokument, 9001:2015 into this document;
– prilagoditve terminologiji ISO 9000:2015, če – adjustments to the terminology of ISO
je relevantno, 9000:2015, where relevant;
– vključitev abecednega kazala opredeljenih – the inclusion of an alphabetical index of
izrazov, uporabljenih v tem dokumentu. defined terms used in this document.
SIST EN ISO 15378 : 2018
Uvod Introduction
0.1 Splošno 0.1 General
Ta dokument opredeljuje načela dobre This document identifies Good Manufacturing
proizvodne prakse (DPP) in določa zahteve za Practice (GMP) principles and specifies
sistem vodenja kakovosti na področju primarnih requirements for a quality management system
embalažnih materialov za zdravila. Izvajanje applicable to primary packaging materials for
DPP pri proizvodnji in nadzoru primarnih medicinal products. The realization of GMP
embalažnih materialov je zaradi neposrednega principles in production and control of primary
stika z zdravilom zelo pomembno za varnost packaging materials within organizations is of
pacienta, ki ga uporablja. Uporaba DPP za great importance for the safety of a patient using
farmacevtske embalažne materiale pomaga the medicinal product, because of their direct
zagotoviti, da ti materiali izpolnjujejo potrebe in product contact. The application of GMP for
zahteve farmacevtske industrije. pharmaceutical packaging materials helps
ensure that these materials meet the needs and
requirements of the pharmaceutical industry.
Ta dokument je aplikacijski standard za primarne This document is an application standard for
embalažne materiale in vsebuje besedilo primary packaging materials, which contains the
standarda ISO 9001:2015. text of ISO 9001:2015.
Dogovori o postavitvi tega dokumenta so The conventions for the layout of this document
naslednji: are the following.
– Tiste točke, podtočke ali dodatki, ki so – Those clauses, subclauses or annexes that
citirani neposredno in nespremenjeno iz are quoted directly and unchanged from
ISO 9001:2015 in ISO 9000:2015 (pod ISO 9001:2015 and ISO 9000:2015 (under
točko 3), so v okvirjih. Clause 3) are in boxes.
– Dodatne zahteve in priporočila v zvezi z – Additional GMP related requirements and
DPP ter izrazi in definicije, ki so relevantni recommendations as well as terms and
za proizvodnjo primarnih embalažnih definitions relevant to the manufacture of
materialov, so zunaj okvirjev. primary packaging materials are outside
boxes.
ISO 9001:2015, Sistemi vodenja kakovosti – ISO 9001:2015, Quality management
Zahteve systems – Requirements
0.1 Splošno 0.1 General
Privzem sistema vodenja kakovosti je The adoption of a quality management system
strateška odločitev organizacije, ki ji lahko is a strategic decision for an organization that
pomaga izboljšati celotno izvajanje in daje can help to improve its overall performance
trdno podlago pobudam za trajnostni razvoj. and provide a sound basis for sustainable
development initiatives.
Koristi, ki jih ima lahko organizacija od The potential benefits to an organization of
izvajanja sistema vodenja kakovosti na implementing a quality management system
podlagi tega mednarodnega standarda, so: based on this International Standard are:
a) zmožnost, da dosledno zagotavlja izdelke a) the ability to consistently provide products
in storitve, ki izpolnjujejo zahteve and services that meet customer and
odjemalcev ter veljavne zahteve applicable statutory and regulatory
zakonodaje in regulative; requirements;
b) dajanje priložnosti za povečanje b) facilitating opportunities to enhance
zadovoljstva odjemalcev; customer satisfaction;
SIST EN ISO 15378 : 2018
c) obravnavanje tveganj in priložnosti, c) addressing risks and opportunities
povezanih z njenim kontekstom in cilji; associated with its context and objectives;
d) zmožnost, da dokaže izpolnjevanje d) the ability to demonstrate conformity to
skladnosti s specificiranimi zahtevami specified quality management system
sistema vodenja kakovosti. requirements.
Ta mednarodni standard lahko uporabljajo This International Standard can be used by
strani znotraj in zunaj organizacije. internal and external parties.
Ta mednarodni standard nima namena It is not the intent of this International Standard
nakazovati potrebe po: to imply the need for:
– enotni zgradbi različnih sistemov vodenja – uniformity in the structure of different
kakovosti; quality management systems;
– uskladitvi dokumentacije s strukturo točk – alignment of documentation to the clause
tega mednarodnega standarda; structure of this International Standard;
– uporabi specifične terminologije tega – the use of the specific terminology of this
mednarodnega standarda v organizaciji. International Standard within the
organization.
Zahteve sistema vodenja kakovosti, določene The quality management system requirements
v tem mednarodnem standardu, dopolnjujejo specified in this International Standard are
zahteve za izdelke in storitve. complementary to requirements for products
and services.
Ta mednarodni standard uporablja procesni This International Standard employs the
pristop, ki vključuje cikel "planiraj-izvedi- process approach, which incorporates the
preveri-ukrepaj" (PDCA) in razmišljanje na Plan-Do-Check- Act (PDCA) cycle and risk-
podlagi tveganja. based thinking.
Procesni pristop pomaga organizaciji planirati The process approach enables an organization
njene procese in njihovo interakcijo. to plan its processes and their interactions.
Cikel PDCA pomaga organizaciji zagotavljati, The PDCA cycle enables an organization to
da svoje procese podpre z ustreznimi viri in jih ensure that its processes are adequately
vodi ter da identificira priložnosti za izboljšanje resourced and managed, and that
in ustrezno ukrepa. opportunities for improvement are determined
and acted on.
Razmišljanje na podlagi tveganja pomaga Risk-based thinking enables an organization to
organizaciji opredeliti dejavnike, ki bi lahko determine the factors that could cause its
povzročili odstopanje njenih procesov in processes and its quality management system
njenega sistema vodenja kakovosti od to deviate from the planned results, to put in
planiranih rezultatov, sprejeti preventivne place preventive controls to minimize negative
ukrepe za zmanjšanje negativnih vplivov ter effects and to make maximum use of
kar najbolje izkoristiti priložnosti, ko se opportunities as they arise (see
ponudijo (glej točko A.4). Clause A.4).
Dosledno izpolnjevanje zahtev ter Consistently meeting requirements and
obravnavanje prihodnjih potreb in pričakovanj addressing future needs and expectations
v vse bolj dinamičnem in kompleksnem okolju poses a challenge for organizations in an
predstavljata za organizacije velik izziv. Da bi increasingly dynamic and complex
organizacija dosegla ta cilj, se ji lahko zdi environment. To achieve this objective, the
potrebno, da poleg korekcij in nenehnega organization might find it necessary to adopt
izboljševanja sprejme različne oblike izboljšav, various forms of improvement in addition to
SIST EN ISO 15378 : 2018
kot so na primer prebojne spremembe, correction and continual improvement, such as
inovacije in reorganizacija. breakthrough change, innovation and re-
organization.
V tem mednarodnem standardu so uporabljene In this International Standard, the following
naslednje glagolske oblike: verbal forms are used:
– "treba je" ali "mora" označuje zahtevo; – “shall” indicates a requirement;
– "naj" označuje priporočilo; – “should” indicates a recommendation;
– "sme" označuje dovoljenje; – “may” indicates a permission;
– "lahko" označuje možnost ali sposobnost. – “can” indicates a possibility or a
capability.
Informacije, označene kot "OPOMBA:", so Information marked as “NOTE” is for guidance
namenjene usmerjanju pri razumevanju ali in understanding or clarifying the associated
pojasnjevanju pripadajoče zahteve. requirement.
Ključni cilj tega dokumenta je določiti DPP za A key objective of this document is to specify
primarne embalažne materiale. GMP for primary packaging materials.
0.2 Načela vodenja kakovosti 0.2 Quality management principles
ISO 9001:2015, Sistemi vodenja kakovosti ISO 9001:2015, Quality management
– Zahteve systems – Requirements
0.2 Načela vodenja kakovosti 0.2 Quality management principles
Ta mednarodni standard temelji na načelih This International Standard is based on the
vodenja kakovosti, ki so opisana v ISO 9000. quality management principles described in
Opisi vključujejo trditev za posamezno načelo, ISO 9000. The descriptions include a
utemeljitev, zakaj je načelo pomembno za statement of each principle, a rationale of why
organizacijo, nekaj primerov koristi, the principle is important for the organization,
povezanih z načelom, ter primere tipičnih some examples of benefits associated with
ukrepov za izboljšanje učinkov delovanja the principle and examples of typical actions
organizacije pri izvajanju načela. to improve the organization's performance
when applying the principle.
Načela vodenja kakovosti so: The quality management principles are:
– osredotočenost na odjemalce, – customer focus;
– voditeljstvo, – leadership;
– angažiranost ljudi, – engagement of people;
– procesni pristop, – process approach;
– izboljševanje, – improvement;
– odločanje na podlagi dejstev, – evidence-based decision making;
– upravljanje odnosov. – relationship management.
SIST EN ISO 15378 : 2018
0.3 Procesni pristop 0.3 Process approach
0.3.1 Splošno 0.3.1 General
ISO 9001:2015, Sistemi vodenja kakovosti ISO 9001:2015, Quality management
– Zahteve systems – Requirements
0.3 Procesni pristop 0.3 Process approach
0.3.1 Splošno 0.3.1 General
Ta mednarodni standard spodbuja privzem This International Standard promotes the
procesnega pristopa pri razvijanju, izvajanju in adoption of a process approach when
izboljševanju uspešnosti sistema vodenja developing, implementing and improving the
kakovosti, da bi se z izpolnjevanjem zahtev effectiveness of a quality management
odjemalcev povečalo njihovo zadovoljstvo. V system, to enhance customer satisfaction by
točko 4.4 so vključene posebne zahteve, ki se meeting customer requirements. Specific
štejejo za bistvene za privzem procesnega requirements considered essential to the
pristopa. adoption of a process approach are included
in 4.4.
Razumevanje in vodenje medsebojno Understanding and managing interrelated
povezanih procesov kot sistema prispevata k processes as a system contributes to the
uspešnosti in učinkovitosti organizacije pri organization's effectiveness and efficiency in
doseganju predvidenih rezultatov. Ta pristop achieving its intended results. This approach
pomaga organizaciji obvladovati medsebojne enables the organization to control the
povezave in soodvisnost med procesi v interrelationships and interdependencies
sistemu, tako da se lahko izboljšajo celotni among the processes of the system, so that
učinki delovanja organizacije. the overall performance of the organization
can be enhanced.
Procesni pristop vključuje sistematično The process approach involves the systematic
določitev in vodenje procesov ter njihove definition and management of processes, and
interakcije za doseganje predvidenih their interactions, so as to achieve the
rezultatov v skladu s politiko kakovosti in intended results in accordance with the quality
strateško usmeritvijo organizacije. Procese in policy and strategic direction of the
celotni sistem je mogoče voditi z uporabo cikla organization. Management of the processes
PDCA (glej točko 0.3.2) s splošnim and the system as a whole can be achieved
poudarkom na razmišljanju na podlagi using the PDCA cycle (see 0.3.2) with an
tveganja (glej točko 0.3.3), namenjenem overall focus on risk-based thinking (see
preprečevanju neželenih rezultatov. 0.3.3) aimed at taking advantage of
opportunities and preventing undesirable
results.
Uporaba procesnega pristopa v sistemu The application of the process approach in a
vodenja kakovosti omogoča: quality management system enables:
a) razumevanje zahtev in njihovo dosledno a) understanding and consistency in
izpolnjevanje; meeting requirements;
b) obravnavanje procesov z vidika dodane b) the consideration of processes in terms
vrednosti; of added value;
c) doseganje uspešnega izvajanja c) the achievement of effective process
procesov; performance;
d) izboljševanje procesov na podlagi d) improvement of processes based on
ovrednotenja podatkov in informacij. evaluation of data and information.
SIST EN ISO 15378 : 2018
Na sliki 1 sta shematično prikazana katerikoli Figure 1 gives a schematic representation of
proces in interakcija med njegovimi elementi. any process and shows the interaction of its
Za vsak proces so specifične nadzorne in elements. The monitoring and measuring
merilne kontrolne točke, ki so potrebne za check points, which are necessary for control,
obvladovanje in se spreminjajo glede na are specific to each process and will vary
tveganja, povezana s procesom. depending on the related risks.
Slika 1: Shematični prikaz elementov posamičnega procesa
Figure 1 – Schematic representation of the elements of a single process
SIST EN ISO 15378 : 2018
0.3.2 Cikel planiraj-izvedi-preveri-ukrepaj 0.3.2 Plan-Do-Check-Act cycle
ISO 9001:2015, Sistemi vodenja kakovosti ISO 9001:2015, Quality management
– Zahteve systems – Requirements
0.3.2 Cikel planiraj-izvedi-preveri-ukrepaj 0.3.2 Plan-Do-Check-Act cycle
Cikel PDCA se lahko uporablja pri vseh The PDCA cycle can be applied to all
procesih in pri celotnem sistemu vodenja processes and to the quality management
kakovosti. Na sliki 2 je ponazorjeno, kako je system as a whole. Figure 2 illustrates how
mogoče točke od 4 do 10 v zvezi s ciklom Clauses 4 to 10 can be grouped in relation to
PDCA razvrstiti po skupinah. the PDCA cycle.
OPOMBA: Številke v oklepajih se nanašajo na točke v tem mednarodnem standardu.
Slika 2: Prikaz zgradbe tega mednarodnega standarda v ciklu PDCA
SIST EN ISO 15378 : 2018
NOTE Numbers in brackets refer to the clauses in this International Standard.
Figure 2 – Representation of the structure of this International Standard in the PDCA cycle
Cikel PDCA je mogoče na kratko opisati The PDCA cycle can be briefly described as
takole: follows:
Planiraj: vzpostavi cilje sistema in njegove ‒ Plan: establish the objectives of the
procese ter vire, potrebne za doseganje system and its processes, and the
rezultatov v skladu z zahtevami odjemalcev in resources needed to deliver results in
politiko organizacije, ter identificiraj in accordance with customers'
obravnavaj tveganja in priložnosti. requirements and the organization's
policies, and identify and address risks
and opportunities;
‒ Do: implement what was planned;
Izvedi: izvedi, kar je planirano.
‒ Check: monitor and (where applicable)
Preveri: nadzoruj in (kjer je primerno) meri
measure processes and the resulting
procese ter nastale izdelke in storitve glede na
products and services against policies,
politiko, cilje, zahteve in načrtovane aktivnosti
objectives, requirements and planned
ter poročaj o rezultatih.
activities, and report the results;
‒ Act: take actions to improve
Ukrepaj: po potrebi ukrepaj, da se izvajanje
performance, as necessary.
izboljša.
SIST EN
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