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)

ISO 15378:2006 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 15378:2006 is an application standard for the design, manufacture and supply of primary packaging materials for medicinal products. It is also applicable for certification purposes.

Primärverpackungen für Arzneimittel - Besondere Anforderungen für die Anwendung von ISO 9001:2000 entsprechend der Guten Herstellungspraxis (GMP) (ISO 15378:2006)

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 9001:2000, Qualitätsmanagementsysteme  Anforderungen
1.1   Allgemeines
Diese Internationale Norm legt Anforderungen an ein Qualitätsmanagementsystem fest, wenn eine Organisation
a)   ihre Fähigkeit zur ständigen Bereitstellung von Produkten darzulegen hat, die die Anforderungen der Kunden und die zutreffenden behördlichen Anforderungen erfüllen, und
b)   danach strebt, die Kundenzufriedenheit durch wirksame Anwendung des Systems zu erhöhen, einschließlich der Prozesse zur ständigen Verbesserung des Systems und der Zusicherung der Einhaltung der Anforderungen der Kunden und der zutreffenden behördlichen Anforderungen
ANMERKUNG   In dieser Internationalen Norm bezieht sich die Benennung Produkt nur auf Produkte, die für einen Kunden vorgesehen sind oder von diesem gefordert 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 9001:2000, Qualitätsmanagementsysteme  Anforderungen
1.2   Anwendung
Alle in dieser Internationalen Norm festgelegten Anforderungen sind allgemeiner Natur und auf alle Organisationen anwendbar, unabhängig von deren Art und Größe und von der Art der bereitgestellten Produkte.

Matériaux d'emballage primaire pour médicaments - Exigences particulières pour l'application de l'ISO 9001:2000 prenant en considération les Bonnes Pratiques de Fabrication (BPF) (ISO 15378:2006)

L'ISO 15378:2006 spécifie les exigences relatives au système de management de la qualité lorsqu'un organisme doit démontrer son aptitude à fournir des articles d'emballage primaire pour les médicaments, conformes de manière cohérente aux exigences des clients, y compris les exigences réglementaires et les Normes internationales applicables aux articles d'emballage primaire.
L'ISO 15378:2006 est une norme d'application destinée à la conception, à la fabrication et à la fourniture des articles d'emballage primaire pour des médicaments. Elle s'applique également à des fins de certification.

Primarni embalažni materiali za medicinske proizvode - Posebne zahteve za uporabo ISO 9001:2000 v povezavi z dobro proizvodno prakso (DPP) (ISO 15378:2006)

General Information

• Status: Withdrawn
• Publication Date: 10-Jul-2007
• Withdrawal Date: 31-Oct-2011
• ICS: 03.100.70 - Management systems
• ICS: 03.120.10 - Quality management and quality assurance
• ICS: 11.040.01 - Medical equipment in general
• Technical Committee: CEN/SS F20 - Quality assurance
• Drafting Committee: CEN/SS F20 - Quality assurance
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• Start Date: 01-Nov-2011
• Completion Date: 01-Nov-2011
• Ref Project: SIST 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)

Relations

• Replaced By: 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)
• Effective Date: 15-Aug-2009

Standards Content (Sample)

SLOVENSKI STANDARD
01-november-2007
Primarni embalažni materiali za medicinske proizvode - Posebne zahteve za
uporabo ISO 9001:2000 v povezavi z dobro proizvodno prakso (DPP) (ISO
15378:2006)
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)
Primärverpackungen für Arzneimittel - Besondere Anforderungen für die Anwendung von
ISO 9001:2000 entsprechend der Guten Herstellungspraxis (GMP) (ISO 15378:2006)
Matériaux d'emballage primaire pour médicaments - Exigences particulieres pour
l'application de l'ISO 9001:2000 prenant en considération les Bonnes Pratiques de
Fabrication (BPF) (ISO 15378:2006)
Ta slovenski standard je istoveten z: EN ISO 15378:2007
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
July 2007
ICS 11.040.01; 03.120.10
English Version
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)
Matériaux d'emballage primaire pour médicaments - Primärverpackungen für Arzneimittel - Besondere
Exigences particulières pour l'application de l'ISO Anforderungen für die Anwendung von ISO 9001:2000
9001:2000 prenant en considération les Bonnes Pratiques entsprechend der Guten Herstellungspraxis (GMP) (ISO
de Fabrication (BPF) (ISO 15378:2006) 15378:2006)
This European Standard was approved by CEN on 22 June 2007.
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 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 Management Centre has the same status as the
official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, 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: rue de Stassart, 36  B-1050 Brussels
© 2007 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 15378:2007: E
worldwide for CEN national Members.

Foreword
The text of ISO15378:2006 has been prepared by Technical Committee ISO/TC 76
"Transfusion, infusion and injection equipment for medical and pharmaceutical use” of the
International Organization for Standardization (ISO) and has been taken over as EN ISO
15378:2007 by Technical Committee CEN/SS F20 "Quality assurance", the secretariat of which
is held by CMC.
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 January 2008, and conflicting national
standards shall be withdrawn at the latest by January 2008.

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, 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.
Endorsement notice
The text of ISO 15378:2006 has been approved by CEN as EN ISO 15378:2007 without any
modifications.
INTERNATIONAL ISO
STANDARD 15378
First edition
2006-03-01
Primary packaging materials for
medicinal products — Particular
requirements for the application of
ISO 9001:2000, with reference to
Good Manufacturing Practice (GMP)
Matériaux d'emballage primaire pour médicaments — Exigences
particulières pour l'application de l'ISO 9001:2000 prenant en
considération les Bonnes Pratiques de Fabrication (BPF)

Reference number
ISO 15378:2006(E)
©
ISO 2006
ISO 15378:2006(E)
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All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means,
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ISO 15378:2006(E)
Contents Page
Foreword. iv
0 Introduction . v
0.1 General. v
0.2 Process approach. vi
0.3 Relationship with ISO 9004. vii
0.4 Compatibility with other management systems . viii
1 Scope . 1
1.1 General. 1
1.2 Application . 1
2 Normative references . 2
3 Terms and definitions. 2
4 Quality management system . 11
4.1 General requirements. 11
4.2 Documentation requirements. 12
5 Management responsibility . 14
5.1 Management commitment . 14
5.2 Customer focus. 14
5.3 Quality policy . 15
5.4 Planning. 15
5.5 Responsibility, authority and communication. 15
5.6 Management review. 16
6 Resource management . 17
6.1 Provision of resources. 17
6.2 Human resources. 18
6.3 Infrastructure. 19
6.4 Work environment . 19
6.5 Maintenance activities. 20
7 Product realization. 20
7.1 Planning of product realization . 20
7.2 Customer-related processes . 21
7.3 Design and development . 22
7.4 Purchasing . 25
7.5 Production and service provision. 26
7.6 Control of monitoring and measuring devices. 30
8 Measurement, analysis and improvement . 31
8.1 General. 31
8.2 Monitoring and measurement . 31
8.3 Control of nonconforming product. 33
8.4 Analysis of data . 34
8.5 Improvement . 34
Annex A (normative) GMP requirements for printed primary packaging materials. 36
Annex B (informative) Guidance on verification and validation requirements for primary
packaging materials . 40
Annex C (informative) Guidance on risk management for primary packaging materials. 49
Bibliography . 56
Index. 58

ISO 15378:2006(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 responsible for identifying any or all such patent rights.
ISO 15378 was prepared by Technical Committee ISO/TC 76, Transfusion, infusion and injection equipment
for medical and pharmaceutic
...