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)
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.
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
Buy Standard
Standards Content (Sample)
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
2
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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.
3
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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
...
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.
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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
SIST EN ISO 15378:2018 je prevod angleškega besedila evropskega standarda EN ISO 15378:2017.
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
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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
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SIST EN ISO 15378 : 2018
(prazna stran)
IV
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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.
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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.
2
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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
3
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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
4
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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
5
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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:
6
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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.
7
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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
...
SLOVENSKI STANDARD
oSIST prEN ISO 15378:2016
01-oktober-2016
Primarni embalažni materiali za zdravila - Posebne zahteve za uporabo ISO
9001:2008 v povezavi z dobro proizvodno prakso (DPP) (ISO/DIS 15378:2016)
Primary packaging materials for medicinal products - Particular requirements for the
application of ISO 9001:2008, with reference to Good Manufacturing Practice (GMP)
Articles d'emballage primaire pour médicaments - Exigences particulières pour
l'application de l'ISO 9001:2008 prenant en considération les Bonnes Pratiques de
Fabrication (BPF)
Ta slovenski standard je istoveten z: prEN ISO 15378
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
oSIST prEN ISO 15378:2016 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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oSIST prEN ISO 15378:2016
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oSIST prEN ISO 15378:2016
DRAFT INTERNATIONAL STANDARD
ISO/DIS 15378
ISO/TC 76 Secretariat: DIN
Voting begins on: Voting terminates on:
2016-10-04 2016-12-26
Primary packaging materials for medicinal products —
Particular requirements for the application of ISO
9001:2008, with reference to Good Manufacturing
Practice (GMP)
Articles d’emballage primaire pour médicaments — Exigences particulières pour l’application de l’ISO
9001:2008 prenant en considération les Bonnes Pratiques de Fabrication (BPF)
ICS: 11.040.01; 03.120.10
THIS DOCUMENT IS A DRAFT CIRCULATED
This document is circulated as received from the committee secretariat.
FOR COMMENT AND APPROVAL. IT IS
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
ISO/CEN PARALLEL PROCESSING
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
Reference number
NATIONAL REGULATIONS.
ISO/DIS 15378:2016(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
©
PROVIDE SUPPORTING DOCUMENTATION. ISO 2016
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oSIST prEN ISO 15378:2016
ISO/DIS 15378:2016(E) ISO/DIS 15378:2016(E)
Contents Page
Foreword . vi
Introduction . vii
1 Scope .1
2 Normative references .1
3 Terms and definitions .2
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 . 13
4.3 Determining the scope of the quality management system . 13
4.4 Quality management system and its processes . 14
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 Policy . 16
5.2.1 Establishing the quality policy . 16
5.2.2 Communicating the quality policy . 16
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 . 19
7.1.4 Environment for the operation of processes . 20
7.1.5 Monitoring and measuring resources . 22
7.1.6 Organizational knowledge . 23
7.2 Competence . 23
7.2.1 General . 23
7.2.2 GMP-training . 24
7.3 Awareness . 24
7.4 Communication . 24
7.5 Documented information . 25
COPYRIGHT PROTECTED DOCUMENT
7.5.1 General . 25
7.5.2 Creating and updating . 25
© ISO 2016, Published in Switzerland
7.5.3 Control of documented information . 26
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form
7.5.4 Administration of IT systems and data . 27
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
8 Operation . 27
the requester.
8.1 Operational planning and control . 27
ISO copyright office
Ch. de Blandonnet 8 • CP 401 8.2 Requirements for products and services . 28
CH-1214 Vernier, Geneva, Switzerland
8.2.1 Customer communication . 28
Tel. +41 22 749 01 11
8.2.2 Determining the requirements for products and services . 29
Fax +41 22 749 09 47
copyright@iso.org
www.iso.org
© ISO 2016 – All rights reserved
iii
ii © ISO 2016 – All rights reserved
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oSIST prEN ISO 15378:2016
ISO/DIS 15378:2016(E)
Contents Page
Foreword . vi
Introduction . vii
1 Scope .1
2 Normative references .1
3 Terms and definitions .2
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 . 13
4.3 Determining the scope of the quality management system . 13
4.4 Quality management system and its processes . 14
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 Policy . 16
5.2.1 Establishing the quality policy . 16
5.2.2 Communicating the quality policy . 16
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 . 19
7.1.4 Environment for the operation of processes . 20
7.1.5 Monitoring and measuring resources . 22
7.1.6 Organizational knowledge . 23
7.2 Competence . 23
7.2.1 General . 23
7.2.2 GMP-training . 24
7.3 Awareness . 24
7.4 Communication . 24
7.5 Documented information . 25
7.5.1 General . 25
7.5.2 Creating and updating . 25
7.5.3 Control of documented information . 26
7.5.4 Administration of IT systems and data . 27
8 Operation . 27
8.1 Operational planning and control . 27
8.2 Requirements for products and services . 28
8.2.1 Customer communication . 28
8.2.2 Determining the requirements for products and services . 29
© ISO 2016 – All rights reserved
iii
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oSIST prEN ISO 15378:2016
ISO/DIS 15378:2016(E)
8.2.3 Review of the requirements for products and services . 29
8.2.4 Changes to requirements for products and services . 30
8.3 Design and development of products and services . 30
8.3.1 General . 30
8.3.2 Design and development planning . 30
8.3.3 Design and development inputs . 31
8.3.4 Design and development controls . 31
8.3.5 Design and development outputs . 32
8.3.6 Design and development changes . 32
8.4 Control of externally provided processes, products and services . 33
8.4.1 General . 33
8.4.2 Type and extent of control . 33
8.4.3 Information for external providers . 35
8.5 Production and service provision . 35
8.5.1 Control of production and service provision . 35
8.5.2 Identification and traceability . 38
8.5.3 Property belonging to customers or external providers . 39
8.5.4 Preservation. 39
8.5.5 Post-delivery activities . 40
8.5.6 Control of changes. 40
8.6 Release of products and services . 41
8.7 Control of nonconforming outputs . 41
9 Performance evaluation . 42
9.1 Monitoring, measurement, analysis and evaluation . 42
9.1.1 General . 42
9.1.2 Customer satisfaction . 42
9.1.3 Analysis and evaluation . 42
9.2 Internal audit . 44
9.3 Management review . 44
9.3.1 General . 44
9.3.2 Management review inputs . 44
9.3.3 Management review outputs . 45
10 Improvement . 45
10.1 General . 45
10.2 Nonconformity and corrective action . 46
10.3 Continual improvement . 47
Annex A (informative) Clarification of new structure, terminology and concepts . 48
A.1 Structure and terminology . 48
A.2 Products and services . 49
A.3 Understanding the needs and expectations of interested parties . 49
A.4 Risk-based thinking . 49
A.5 Applicability . 50
A.6 Documented information . 50
A.7 Organizational knowledge . 50
A.8 Control of externally provided processes, products and services . 51
Annex B (informative) Other International Standards on quality management and quality
management systems developed by ISO/TC 176 . 52
Annex C (normative) GMP requirements for printed primary packaging materials (as given
in current version). 56
C.1 Artwork / origination and print impression media . 56
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ISO/DIS 15378:2016(E) ISO/DIS 15378:2016(E)
8.2.3 Review of the requirements for products and services . 29
C.1.1 General . 56
8.2.4 Changes to requirements for products and services . 30
C.1.2 Matched plates / cylinders . 56
8.3 Design and development of products and services . 30
C.1.3 Copy/design change . 56
8.3.1 General . 30
C.1.4 Verification . 56
8.3.2 Design and development planning . 30
C.2 Print and conversion processes . 57
8.3.3 Design and development inputs . 31
C.2.1 Print machine set-up (make-ready) . 57
8.3.4 Design and development controls . 31
C.2.2 Changeover systems . 57
8.3.5 Design and development outputs . 32
C.2.3 Retained samples . 57
8.3.6 Design and development changes . 32
C.2.4 Replacement print media . 57
8.4 Control of externally provided processes, products and services . 33
C.2.5 Gang printing . 57
8.4.1 General . 33
C.2.6 Batched production and stock holding . 58
8.4.2 Type and extent of control . 33
C.2.7 Digital printing . 58
8.4.3 Information for external providers . 35
C.3 Security code systems . 58
8.5 Production and service provision . 35
C.3.1 General . 58
8.5.1 Cont
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