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

Status
Published
Publication Date
24-Oct-2017
Current Stage
6060 - Definitive text made available (DAV) - Publishing
Due Date
25-Oct-2017
Completion Date
25-Oct-2017

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SLOVENSKI STANDARD
SIST EN ISO 15378:2018
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
SIST EN ISO 15378:2018 en,fr,de

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 15378:2018
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SIST EN ISO 15378:2018
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.
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SIST EN ISO 15378:2018
EN ISO 15378:2017 (E)
Contents Page

European foreword ....................................................................................................................................................... 3

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SIST EN ISO 15378:2018
EN ISO 15378:2017 (E)
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.

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SIST EN ISO 15378:2018
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SIST EN ISO 15378:2018
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
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SIST EN ISO 15378:2018
ISO 15378:2017(E)
COPYRIGHT PROTECTED DOCUMENT
© 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.
ISO copyright office
Ch. de Blandonnet 8 • CP 401
CH-1214 Vernier, Geneva, Switzerland
Tel. +41 22 749 01 11
Fax +41 22 749 09 47
copyright@iso.org
www.iso.org
ii © ISO 2017 – All rights reserved
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SIST EN ISO 15378:2018
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 2017 – All rights reserved iii
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SIST EN ISO 15378:2018
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
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SIST EN ISO 15378:2018
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 2017 – All rights reserved v
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SIST EN ISO 15378:2018
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
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SIST EN I
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