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)

This International Standard specifies requirements for a quality management system where an organization a) needs to demonstrate its ability to consistently provide product that meets customer and applicable statutory and regulatory requirements, and b) aims to enhance customer satisfaction through the effective application of the system, including processes for continual improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements.

Primärverpackungen 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
• Public Enquiry End Date: 28-Sep-2011
• Publication Date: 07-Mar-2012
• Withdrawal Date: 15-Nov-2015
• ICS: 03.120.10 - Quality management and quality assurance
• ICS: 11.040.01 - Medical equipment in general
• Technical Committee: VZK - Quality management and quality assurance
• Current Stage: 9900 - Withdrawal (Adopted Project)
• Start Date: 16-Nov-2015
• Due Date: 09-Dec-2015
• Completion Date: 16-Nov-2015
• Ref Project: 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)

Relations

• Replaced By: SIST 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: 01-Dec-2015
• Replaces: 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)
• Effective Date: 01-Apr-2012
• Replaces: 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)
• Effective Date: 08-Jun-2022

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 15378:2012
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
SIST EN ISO 15378:2012 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------

SIST EN ISO 15378:2012

---------------------- Page: 2 ----------------------

SIST EN ISO 15378:2012


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.

---------------------- Page: 3 ----------------------

SIST EN ISO 15378:2012
EN ISO 15378:2011 (E)
Contents Page
Foreword .3

2

---------------------- Page: 4 ----------------------

SIST EN ISO 15378:2012
EN ISO 15378:2011 (E)
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.

3

---------------------- Page: 5 ----------------------

SIST EN ISO 15378:2012

---------------------- Page: 6 ----------------------

SIST EN ISO 15378:2012

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

---------------------- Page: 7 ----------------------

SIST EN ISO 15378:2012
ISO 15378:2011(E)

COPYRIGHT PROTECTED DOCUMENT


©  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.
ISO copyright office
Case postale 56  CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail [e-mail]
Web www.iso.org
Published in Switzerland

ii © ISO 2011 – All rights reserved

---------------------- Page: 8 ----------------------

SIST EN ISO 15378:2012
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 2011 – All rights reserved iii

---------------------- Page: 9 ----------------------

SIST EN ISO 15378:2012
ISO 15378:2011(E)
Bibliography .63
Index .65

iv © ISO 2011 – All rights reserved

---------------------- Page: 10 ----------------------

SIST EN ISO 15378:2012
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 responsible for identifying any or all such patent rights.
ISO 15378 was prepared by Technical Committee ISO/TC 76, Transfusion, infusion and injection, and blood
processing equipment for medical and pharmaceutical use.
This second edition cancels and replaces the first edition (ISO 15378:2006), which has undergone a minor
revision to adapt this International Standard to ISO 9001:2008 and update references.
© ISO 2011 – All rights reserved v

---------------------- Page: 11 ----------------------

SIST EN ISO 15378:2012
ISO 15378:2011(E)
Introduction
0.1 General
This International Standard 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 International Standard is an application standard for primary packaging materials, which contains the
normative text of ISO 9001:2008.
The conventions for the layout of this International Standard are the following.
 Those clauses or subclauses that are quoted directly and unchanged from ISO 9001:2008 are in boxed
text.
 Texts in italics contain additional relevant GMP information regarding primary packaging materials.
GMP terms and definitions are included in Clause 3. If listed, the source is referred to in brackets.
vi © ISO 2011 – All rights reserved

---------------------- Page: 12 ----------------------

SIST EN ISO 15378:2012
ISO 15378:2011(E)
ISO 9001:2008, Quality management systems — Requirements
0.1 General
The adoption of a quality management system should be a strategic decision of an organization. The
design and implementation of an organization's quality management system is influenced by
a) its organizational environment, changes in that environment, and the risks associated with that
environment,
b) its varying needs,
c) its particular objectives,
d) the products it provides,
e) the processes it employs,
f) its size and organizational structure.
It is not the intent of this International Standard to imply uniformity in the structure of quality management
systems or uniformity of documentation.
The quality management system requirements specified in this International Standard are
complementary to requirements for products. Information marked “NOTE” is for guidance in
understanding or clarifying the associated requirement.
This International Standard can be used by internal and external parties, including certification bodies, to
assess the organization's ability to meet customer, statutory and regulatory requirements applicable to
the product, and the organization's own requirements.
The quality management principles stated in ISO 9000 and ISO 9004 have been taken into consideration
during the development of this International Standard.


A key objective of this International Standard is to define harmonized primary packaging material
requirements. It includes some particular requirements for primary packaging materials, which are derived
from Good Manufacturing Practices for the production, control, etc. of medicinal products.
© ISO 2011 – All rights reserved vii

---------------------- Page: 13 ----------------------

SIST EN ISO 15378:2012
ISO 15378:2011(E)
0.2 Process approach
ISO 9001:2008, Quality management systems — Requirements
0.2 Process approach
This International Standard promotes the adoption of a process approach when developing,
implementing and improving the effectiveness of a quality management system, to enhance customer
satisfaction by meeting customer requirements.
For an organization to function effectively, it has to determine and manage numerous linked activities. An
activity or set of activities using resources, and managed in order to enable the transformation of inputs
into outputs, can be considered a process. Often the output from one process directly forms the input to
the next.
The application of a system of processes within an organization, together with the identification and
interactions of these processes, and their management to produce the desired outcome, can be referred
to as the “process approach”.
An advantage of the process approach is the ongoing control that it provides over the linkage between
the individual processes within the system of processes, as well as over their combination and
interaction.
When used within a quality management system, such an approach emphasizes the importance of
a) understanding and meeting requirements,
b) the need to consider processes in terms of added value,
c) obtaining results of process performance and effectiveness, and
d) continual improvement of processes based on objective measurement.
The model of a process-based quality management system shown in Figure 1 illustrates the process
linkages presented in Clauses 4 to 8. This illustration shows that customers play a significant role in
defining requirements as inputs. Monitoring of customer satisfaction requires the evaluation of
information relating to customer perception as to whether the organization has met the customer
requirements. The model shown in Figure 1 covers all the requirements of this International Standard,
but does not show processes at a detailed level.
NOTE In addition, the methodology known as “Plan-Do-Check-Act” (PDCA) can be applied to all processes.
PDCA can be briefly described as follows.
Plan: establish the objectives and processes necessary to deliver results in accordance with customer
requirements and the organization's policies.
Do: implement the processes.
Check: monitor and measure processes and product against policies, objectives and requirements for the product
and report the results.
Act: take actions to continually improve process performance.


viii © ISO 2011 – All rights reserved

---------------------- Page: 14 ----------------------

SIST EN ISO 15378:2012
ISO 15378:2011(E)


Figure 1 — Model of a process-based quality management system
© ISO 2011 – All rights reserved ix

---------------------- Page: 15 ----------------------

SIST EN ISO 15378:2012
ISO 15378:2011(E)
0.3 Relationship with ISO 9004
ISO 9001:2008, Quality management systems — Requirements
0.3 Relationship with ISO 9004
ISO 9001 and ISO 9004 are quality management system standards which have been designed to
complement each other, but can also be used independently.
ISO 9001 specifies requirements for a quality management system that can be used for internal
application by organizations, or for certification, or for contractual purposes. It focuses on the
effectiveness of the quality management system in meeting customer requirements.
At the time of publication of this International Standard, ISO 9004 is under revision. The revised edition of
ISO 9004 will provide guidance to management for achieving sustained success for any organization in a
complex, demanding, and ever changing, environment. ISO 9004 provides a wider focus on quality
management than ISO 9001; it addresses the needs and expectations of all interested parties and their
satisfaction, by the systematic and continual improvement of the organization's performance. However, it
is not intended for certification, regulatory or contractual use.


0.4 Compatibility with other management systems
This International Standard incorporates the requirements of ISO 9001:2008 and, additionally, particular
requirements for primary packaging materials, which are derived and adapted, as appropriate, from Good
Manufacturing Practices for the production and control of medicinal products.
ISO 9001:2008, Quality management systems — Requirements
0.4 Compatibility with other management systems
During the development of this International Standard, due consideration was given to the provisions of
ISO 14001:2004 to enhance the compatibility of the two standards for the benefit of the user community.
Annex A shows the correspondence between ISO 9001:2008 and ISO 14001:2004.
This International Standard does not include requirements specific to other management systems, such
as those particular to environmental management, occupational health and safety management, financial
management or risk management. However, this International Standard enables an organization to align
or integrate its own quality management system with related management system requirements. It is
possible for an organization to adapt its existing management system(s) in order to establish a quality
management system that complies with the requirements of this International Standard.


x © ISO 2011 – All rights reserved

---------------------- Page: 16 ----------------------

SIST EN ISO 15378:2012
INTERNATIONAL STANDARD ISO 15378:2011(E)

Primary packaging materials for medicinal products —
Particular requirements for the application of ISO 9001:2008,
with reference to Good Manufacturing Practice (GMP)
1 Scope
1.1 General
This International Standard 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.
In this International Standard 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 9001:2008, Quality management systems — Requirements
1.1 General
This International Standard specifies requirements for a quality management system where an
organization
a) needs to demonstrate its ability to consistently provide product that meets customer and applicable
statutory and regulatory requirements, and
b) aims to enhance customer satisfaction through the effective application of the system, including
processes for continual improvement of the system and the assurance of conformity to customer
and applicable statutory and regulatory requirements.
NOTE 1 In this International Standard, the term “product” only applies to
a) product intended for, or required by, a customer,
b) any intended output resulting from the product realization processes.
NOTE 2 Statutory and regulatory requirements can be expressed as legal requirements.

1.2 Application
This International Standard is an application standard for the design, manufacture and supply of primary
packaging materials for medicinal products. It is also applicable for certification purposes.
© ISO 2011 – All rights reserved 1

---------------------- Page: 17 ----------------------

SIST EN ISO 15378:2012
ISO 15378:2011(E)
ISO 9001:2008, Quality management systems — Requirements
1.2 Application
All requirements of this International Standard are generic and are intended to be applicable to all
organizations, regardless of type, size and product provided.
Where any requirement(s) of this International Standard cannot be applied due to the nature of an
organization and its product, this can be considered for exclusion.
Where exclusions are made, claims of conformity to this International Standard are not acceptable
unless these exclusions are limited to requirements within Clause 7, and such exclusions do not affect
the organization's ability, or responsibility, to provide product that meets customer and applicable
statutory and regulatory requirements.

2 Normative references
The following referenced documents are indispensable for the application of this document. For dated
references, only the edition cited applies. For undated references, the latest edition of the referenced
document (including any amendments) applies.
ISO 9001:2008, Quality management systems — Requirements
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated
references, only the edition cited applies. For undated references, the latest edition of the referenced
document (including any amendments) applies.
ISO 9000:2005, Quality management systems — Fundamentals and vocabulary

1 )
ISO 14644-1:— , Cleanrooms and associated controlled environments — Part 1: Classification of air
cleanliness by particle concentration
ISO 14644-2, Cleanrooms and associated controlled environments — Part 2: Specifications for monitoring
and periodic testing to prove continued compliance with ISO 14644-1
ISO 14644-3, Cleanrooms and associated controlled environments — Part 3: Test methods
ISO 14644-5, Cleanrooms and associated controlled environments — Part 5: Operations
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 9000 apply.

1) To be published. (Revision of ISO 14644-1:1999)
2 © ISO 2011 – All rights reserved

---------------------- Page: 18 ----------------------

SIST EN ISO 15378:2012
ISO 15378:2011(E)
ISO 9001:2008, Quality management systems — Requirements
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 9000 apply.
Throughout the text of this International Standard, wherever the term “product” occurs, it can also mean
“service”.


Additional terms and definitions used in this International Standard are specific to Good Manufacturing
Practices applicable to the manufacture of primary packaging materials for medicinal products.
3.1
air-lock
enclosed space to control air-flow
NOTE The space typically has at least two interlocked doors between two or more rooms, used either by people or
for goods, to control for different conditions, e.g. cleanliness, air-flow upon entering.
3.2
approved
confirmed conformity status
NOTE Conformity can be confirmed for any stage of the process (starting materials, process aids, packaging material
or finished product).
3.3
assembly
fitting together of primary packaging materials (3.35.1) and/or components
NOTE Examples may include pipette assemblies for filling, prepared components of injection systems or positioning
of needle shields on prefillable syringes.
3.4
automated inspection
conformity evaluation performed by inspection equipment without manual intervention
NOTE The inspection equipment can include optoelectronics (cameras), laser systems, ultrasonics and their
associated data processing functions or others.
3.5
batch
lot
defined quantity of primary packaging material (3.35.1) manufactu
...