EN ISO 15378:2011

Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2008, with reference to Good Manufacturing Practice (GMP) (ISO 15378:2011)

ISO 15378:2011 specifies requirements 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 applicable to primary packaging materials.
ISO 15378:2011 is an application standard for the design, manufacture and supply of primary packaging materials for medicinal products. It is also applicable for certification purposes.

Primärpackmittel für Arzneimittel - Besondere Anforderungen für die Anwendung von ISO 9001:2008 entsprechend der Guten Herstellungspraxis (GMP) (ISO 15378:2011)

1.1   Allgemeines
Diese Internationale Norm legt Anforderungen für ein Qualitätsmanagementsystem fest, bei dem eine Organisation ihre Fähigkeit nachweisen muss, Primärpackmittel zur pharmazeutischen Verwendung zu liefern, die stets den Anforderungen der Kunden - inklusive den gesetzlichen Bestimmungen und den auf Primärpackmittel anwendbaren Internationalen Normen - entsprechen.
In dieser Internationalen Norm 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.
ISO 9001:2008, Qualitätsmanagementsysteme - Anforderungen
1.1   Allgemeines
Diese Internationale Norm legt Anforderungen an ein Qualitätsmanagementsystem fest, wenn eine Organisa-tion
a)   ihre Fähigkeit zur ständigen Bereitstellung von Produkten darzulegen hat, 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 ständigen Verbesserung des Systems und der Zusicherung der Einhaltung der Anforderungen der Kunden und der zutreffenden gesetzlichen und behördlichen Anforderungen.
ANMERKUNG 1   In dieser Internationalen Norm bezieht sich die Benennung "Produkt" nur auf
a)   solche Produkte, die für einen Kunden vorgesehen sind oder von diesem gefordert werden,
b)   alle beabsichtigten Ergebnisse der Produktrealisierungsprozesse.
ANMERKUNG 2   Gesetzliche und behördliche Anforderungen können auch als rechtliche Anforderungen bezeichnet werden.
1.2   Anwendung
Diese Internationale Norm ist eine Anwendungsnorm für das Design, die Herstellung und Lieferung von Primärpackmitteln für Arzneimittel. Sie ist auch zum Zweck der Zertifizierung anwendbar.
ISO 9001:2008, Qualitätsmanagementsysteme - Anforderungen
1.2   Anwendung
Alle in dieser Internationalen Norm festgelegten Anforderungen sind allgemeiner Natur und auf alle Organisa-tionen anwendbar, unabhängig von deren Art und Größe und von der Art der bereitgestellten Produkte.
Wenn sich aufgrund des Charakters einer Organisation und ihrer Produkte eine oder mehrere Anforderungen dieser Internationalen Norm nicht anwenden lassen, kann für diese ein Ausschluss in Betracht gezogen werden.
Wenn Ausschlüsse vorgenommen werden, ist das Beanspruchen der Konformität mit dieser Internationalen Norm nur zulässig, wenn die Ausschlüsse auf Anforderungen aus Abschnitt 7 beschränkt sind und derartige Ausschlüsse die Fähigkeit oder Verantwortung der Organisation zur Bereitstellung von Produkten, die den Kunden  und zutreffenden gesetzlichen und behördlichen Anforderungen entsprechen, nicht beeinträchtigen.

Articles de conditionnement primaire pour médicaments - Exigences particulières pour l'application de l'ISO 9001:2008 prenant en considération les Bonnes Pratiques de Fabrication (BPF) (ISO 15378:2011)

L'ISO 15378:2011 spécifie les exigences relatives au système de management de la qualité lorsqu'un organisme doit démontrer son aptitude à fournir des articles de conditionnement primaire pour les médicaments, conformes de manière cohérente aux exigences des clients, y compris les exigences réglementaires et les Normes internationales applicables aux articles de conditionnement primaire.
L'ISO 15378:2011 est une norme d'application destinée à la conception, à la fabrication et à la fourniture des articles de conditionnement primaire pour des médicaments. Elle s'applique également à des fins de certification.

Primarni embalažni materiali za medicinske proizvode - Posebne zahteve za uporabo ISO 9001:2008 v povezavi z dobro proizvodno prakso (DPP) (ISO 15378:2011)

Ta mednarodni standard določa zahteve za sistem vodenja kakovosti. Uporablja se, kadar a) mora organizacija dokazati svojo sposobnost, da dosledno dobavlja proizvode, ki izpolnjujejo zahteve strank ter ustrezne zakonske in regulativne zahteve, ter kadar b) organizacija namerava izboljšati zadovoljstvo strank z učinkovito uporabo sistema, vključno s postopki za nenehno izboljševanje sistema in zagotavljanje skladnosti z zahtevami strank ter ustreznimi zakonskimi in regulativnimi zahtevami.

General Information

• Status: Withdrawn
• Publication Date: 31-Oct-2011
• Withdrawal Date: 03-Nov-2015
• ICS: 03.100.70 - Management systems
• ICS: 03.120.10 - Quality management and quality assurance
• ICS: 11.040.01 - Medical equipment in general
• ICS: 11.120.10 - Medicaments
• ICS: 55.040 - Packaging materials and accessories
• Technical Committee: CEN/SS F20 - Quality assurance
• Drafting Committee: CEN/SS F20 - Quality assurance
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• Completion Date: 04-Nov-2015
• Ref Project: SIST EN ISO 15378:2012 - Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2008, with reference to Good Manufacturing Practice (GMP) (ISO 15378:2011)

Relations

• Replaces: EN ISO 15378:2007 - Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2000, with reference to Good Manufacturing Practice (GMP) (ISO 15378:2006)
• Effective Date: 15-Aug-2009
• Replaced By: EN ISO 15378:2015 - Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2008, with reference to Good Manufacturing Practice (GMP) (ISO 15378:2015)
• Effective Date: 11-Nov-2015

Standards Content (Sample)

SLOVENSKI STANDARD
01-april-2012
1DGRPHãþD
SIST EN ISO 15378:2007
Primarni embalažni materiali za medicinske proizvode - Posebne zahteve za
uporabo ISO 9001:2008 v povezavi z dobro proizvodno prakso (DPP) (ISO
15378:2011)
Primary packaging materials for medicinal products - Particular requirements for the
application of ISO 9001:2008, with reference to Good Manufacturing Practice (GMP)
(ISO 15378:2011)
Primärverpackungen für Arzneimittel - Besondere Anforderungen für die Anwendung von
ISO 9001:2008 entsprechend der Guten Herstellungspraxis (GMP) (ISO 15378:2011)
Articles de conditionnement primaire pour médicaments - Exigences particulières pour
l'application de l'ISO 9001:2008 prenant en considération les Bonnes Pratiques de
Fabrication (BPF) (ISO 15378:2011)
Ta slovenski standard je istoveten z: EN ISO 15378:2011
ICS:
03.120.10 Vodenje in zagotavljanje Quality management and
kakovosti quality assurance
11.040.01 Medicinska oprema na Medical equipment in general
splošno
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD
EN ISO 15378
NORME EUROPÉENNE
EUROPÄISCHE NORM
November 2011
ICS 03.120.10; 11.040.01 Supersedes EN ISO 15378:2007
English Version
Primary packaging materials for medicinal products - Particular
requirements for the application of ISO 9001:2008, with
reference to Good Manufacturing Practice (GMP) (ISO
15378:2011)
Articles de conditionnement primaire pour médicaments - Primärpackmittel für Arzneimittel - Besondere
Exigences particulières pour l'application de l'ISO Anforderungen für die Anwendung von ISO 9001:2008
9001:2008 prenant en considération les Bonnes Pratiques entsprechend der Guten Herstellungspraxis (GMP) (ISO
de Fabrication (BPF) (ISO 15378:2011) 15378:2011)
This European Standard was approved by CEN on 3 November 2011.

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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland,
Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.

EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2011 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 15378:2011: E
worldwide for CEN national Members.

Contents Page
Foreword .3

Foreword
This document (EN ISO 15378:2011) 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 May 2012, and conflicting national standards shall be withdrawn at the
latest by May 2012.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 15378:2007.
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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain,
Sweden, Switzerland and the United Kingdom.
Endorsement notice
The text of ISO 15378:2011 has been approved by CEN as a EN ISO 15378:2011 without any modification.

INTERNATIONAL ISO
STANDARD 15378
Second edition
2011-11-01
Primary packaging materials for
medicinal products — Particular
requirements for the application of
ISO 9001:2008, with reference to Good
Manufacturing Practice (GMP)
Articles de conditionnement primaire pour médicaments — Exigences
particulières pour l'application de l'ISO 9001:2008 prenant en
considération les Bonnes Pratiques de Fabrication (BPF)

Reference number
ISO 15378:2011(E)
©
ISO 2011
ISO 15378:2011(E)
©  ISO 2011
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means,
electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or
ISO's member body in the country of the requester.
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Published in Switzerland
ii © ISO 2011 – All rights reserved

ISO 15378:2011(E)
Contents Page
Foreword . v
Introduction . vi
0.1  General . vi
0.2  Process approach . viii
0.3  Relationship with ISO 9004 . x
0.4  Compatibility with other management systems . x
1  Scope . 1
1.1  General . 1
1.2  Application . 1
2  Normative references . 2
3  Terms and definitions . 2
4  Quality management system . 12
4.1  General requirements . 12
4.2  Documentation requirements . 13
5  Management responsibility . 16
5.1  Management commitment . 16
5.2  Customer focus . 16
5.3  Quality policy . 17
5.4  Planning . 17
5.5  Responsibility, authority and communication . 18
5.6  Management review . 19
6  Resource management . 20
6.1  Provision of resources . 20
6.2  Human resources . 20
6.3  Infrastructure . 22
6.4  Work environment . 22
6.5  Maintenance activities . 23
7  Product realization . 24
7.1  Planning of product realization . 24
7.2  Customer-related processes . 25
7.3  Design and development . 26
7.4  Purchasing . 29
7.5  Production and service provision . 31
7.6  Control of monitoring and measuring equipment . 36
8  Measurement, analysis and improvement . 37
8.1  General . 37
8.2  Monitoring and measurement . 37
8.3  Control of nonconforming product . 40
8.4  Analysis of data . 41
8.5  Improvement . 41
Annex A (normative) GMP requirements for printed primary packaging materials . 43
Annex B (informative) Guidance on verification and validation requirements for primary
packaging materials . 47
Annex C (informative) Guidance on risk management for primary packaging materials . 56
ISO 15378:2011(E)
Bibliography .63
Index .65

iv © ISO 2011 – All rights reserved

ISO 15378:2011(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.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
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 r
...