EN ISO 15378:2011

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

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

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European
Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national
standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN member.

This European Standard exists in three official versions (English, French, German). A version in any other language made by translation
under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management Centre has the same
status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland,
Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.

EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

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

Contents Page
Foreword .3

Foreword
This document (EN ISO 15378:2011) has been prepared by Technical Committee ISO/TC 76 "Transfusion,
infusion and injection, and blood processing equipment for medical and pharmaceutical use".
This European Standard shall be given the status of a national standard, either by publication of an identical
text or by endorsement, at the latest by May 2012, and conflicting national standards shall be withdrawn at the
latest by May 2012.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 15378:2007.
According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following
countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech
Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain,
Sweden, Switzerland and the United Kingdom.
Endorsement notice
The text of ISO 15378:2011 has been approved by CEN as a EN ISO 15378:2011 without any modification.

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

Reference number
ISO 15378:2011(E)
©
ISO 2011
ISO 15378:2011(E)
©  ISO 2011
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means,
electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or
ISO's member body in the country of the requester.
ISO copyright office
Case postale 56  CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail copyright@iso.org
Web www.iso.org
Published in Switzerland
ii © ISO 2011 – All rights reserved

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

iv © ISO 2011 – All rights reserved

ISO 15378:2011(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies
(ISO member bodies). The work of preparing International Standards is normally carried out through ISO
technical committees. Each member body interested in a subject for which a technical committee has been
established has the right to be represented on that committee. International organizations, governmental and
non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the
International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. ISO shall not be held 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 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

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 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

ISO 15378:2011(E)
Figure 1 — Model of a process-based quality management system
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

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 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

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) manufactured in one process or series of processes
intended to have uniform characteristics with consistent, homogeneous quality
NOTE 1 To meet production requirements or customer needs, a batch can be divided up into a number of sub-batches
that are later combined to form a single, consistent batch.
NOTE 2 In the case of continuous production, the batch is a fraction of the production defined either as a fixed quantity
or as the amount produced in a fixed time interval.
3.6
batch document
batch record
documents and records that provide a history of the batch (3.5), including information relating to its production
and control, and which facilitate its traceability (3.63)
ISO 15378:2011(E)
3.7
batch number
lot number
unique identifier to identify a batch or lot (3.5)
NOTE A batch number can be a combination of numbers, letters and/or symbols which identifies a batch (or lot) and
from which the production and distribution history can be determined.
3.8
batch release
decision to release the batch (3.5) for sale or supply, following a formal review of the batch document (3.6)
performed by the quality unit (3.41) or a person authorized by the quality unit(s)
3.9
calibration
process of checking or adjusting (by comparison with a reference standard) the accuracy of a measuring
instrument
NOTE Calibration can also be described as the set of operations which establish, under specified conditions, the
relationship between values indicated by a measuring instrument or values represented by a material measure, and the
corresponding known values of a reference standard.
3.10
change control
documented control of changes
NOTE Changes can include, for example, changes in raw materials, specifications, facilities, equipment, production
processes and test methods.
3.11
cleanroom
room in which the concentration of airborne particles is controlled, and which is constructed and used in a
manner to minimize the introduction, generation, and retention of particles inside the room, and in which other
relevant parameters, e.g. temperature, humidity, and pressure, are controlled as necessary
[ISO 14644-1:—, 3.1.1]
3.12
clean zone
dedicated space in which the concentration of airborne particles is controlled, and which is constructed and
used in a manner to minimize the introduction, generation, and retention of particles inside the zone, and in
which other relevant parameters, e.g. temperature, humidity, and pressure, are controlled as necessary
[ISO 14644-1:—, 3.1.2]
NOTE This zone may be open or enclosed and may or may not be located within a cleanroom.
3.13
contamination
introduction of any unwanted material into the primary packaging material (3.35.1)
NOTE 1 A finished product can be contaminated by physical (particulate), chemical or biological (bio- and endotoxin
burden) action.
NOTE 2 Contamination can occur during production, packaging, storage and/or distribution from contaminated air
systems, personnel, sampling equipment, materials, premises or containers.
4 © ISO 2011 – All rights reserved

ISO 15378:2011(E)
3.14
controlled area
controlled environment
area or environment constructed and operated to control the possible introduction of potential contaminants
NOTE 1 The area is typically constructed and operated to control the introduction of potential contamination and the
consequences of accidental release of living organisms.
NOTE 2 An appropriate pressure differential allows for the efficient removal of airborne contaminants, potential
contamination and the consequences of accidental release.
3.15
cross-contamination
mix-up
contamination (3.13) of a material or of a product with another material or product
NOTE 1 Cross-contamination may also be referred to as admixture.
NOTE 2 See Reference [24].
3.16
customer complaint
information provided by a customer about deficiencies and/or nonconformities
NOTE 1 The information may be verbally communicated or written.
NOTE 2 The subject of a complaint can include primary packaging material quality, quantity or supply.
3.17
date of manufacture
date on which one of the first stages in the process of manufacture of the primary packaging material, or the
packaging, or the final release, occurs, and which may be subject to customer agreement
3.18
deviation
departure from an approved standard operating procedure (SOP) (3.58) or established standard
3.19
documented procedure
procedure that is established, documented, authorized, implemented and maintained
3.20
double-check
documented verification (3.65) of an activity, result or record by a second person or system
NOTE A second in-process control check signature, production and quality records for a batch signed by a second
person or electronic checks can be part of this verification process. Typically, double-checks are signed by a second
person.
3.21
expiration date
expected suitable use limit
NOTE 1 See also definition shelf-life (3.56).
NOTE 2 This is typically the period during which a primary packaging material is expected to remain suitable for use if
stored under defined conditions and after which it should not be used.
ISO 15378:2011(E)
3.22
final inspection
tests carried out on the finished product (3.23) to determine compliance with the specification
3.23
finished product
primary packaging material (3.35.1) which has completed all stages of production (3.37)
3.24
Good Manufacturing Practice
GMP
quality control and quality assurance applied in manufacturing (3.29)
NOTE 1 For the definitions of quality control and quality assurance, see ISO 9000:2005 (3.2.10 and 3.2.11).
NOTE 2 Requirements for Good Manufacturing Practice in the pharmaceutical industry are specified in a quality
assurance standard, see Reference [24].
NOTE 3 Good Manufacturing Practice (GMP) for primary packaging materials requires, in addition to suitable provision
of personnel, premises and equipment, a quality management system that includes controls for incoming starting materials,
manufacture, corresponding documentation, factory hygiene, final inspection, records of distribution, processing of
complaints and self-inspection.
NOTE 4 GMP and current Good Manufacturing Practice (cGMP) are equivalent. GMP guidelines are continually
updated to the ever-changing requirements of the state-of-the-art. This has resulted in the term cGMP sometimes being
used. The pharmaceutical industry expects that organizations take account of current GMP within their continual
improvement programmes.
3.25
homogeneity
uniformity of characteristics and their values throughout a defined quantity of material
NOTE Homogeneity can include uniformity of materials or certain characteristics of materials of special significance.
3.26
in-process control
actions taken during the production process to test product conformity to its specification
NOTE 1 Monitoring processes and adjusting the means of production can be necessary to meet product requirements.
NOTE 2 The control of the environment or equipment can also be regarded as a part of in-process control.
3.27
intermediate product
primary packaging material (3.35.1) which has completed some but not all production stages
NOTE An intermediate product needs further processing before it becomes a finished product.
3.28
line clearance
removal (line purge) of everything associated with the prior production run
NOTE Typically, line clearance is done prior to a production run to prevent any error and cross-contamination.
Typically, it is required that a production facility (line) and its associated working area are completely clear of all materials,
waste, products, samples, documents, etc. used in the previous production run before the introduction of materials,
product samples, documents, etc. needed for the commencement of the next production run.
3.29
manufacturing
all operations of purchase of materials and primary packaging materials (3.35.1), production (3.37),
quality control (3.39), release, storage, distribution of products and the related controls
6 © ISO 2011 – All rights reserved

ISO 15378:2011(E)
3.30
medicinal product
any substance or combination of substances presented for treating or preventing disease in human beings or
animals
NOTE 1 Any substance or combination of substances that may be administrated to human beings or animals with a
view to making a medical diagnosis or to restoring, correcting or modifying physiological functions in human beings or in
animals is likewise considered a medicinal product.
NOTE 2 See Reference [24].
NOTE 3 Medicinal products may also be referred to as pharmaceutical or drug products, including clinical trial products.
3.31
organization
group of people and facilities with an arrangement of responsibilities, authorities and relationships
[ISO 9000:2005, definition 3.3.1]
NOTE In this International Standard the organization is the company manufacturing the primary packaging material.
3.32
origination
artwork
all preparative activities prior to print
NOTE These include concept, design, graphics, reprographics, film, plate making, silk screens and digital files and
masters.
3.33
out of specification
OOS
test results that do not comply with the specification (3.57)
3.34
outsourcing
provision of all or part of a process by another organization (3.31)
NOTE Outsourcing is often referred to as subcontracting (see definition 3.61 “subcontractor”).
3.35 Packaging materials
3.35.1
primary packaging materials
packaging materials used in pharmaceutical packaging which will contain, seal or be used for dose application
of a medicial product and which will have direct contact with the medicinal product
NOTE 1 Examples of primary packaging materials are glass, rubber, plastics, aluminium containers/components, films,
foils, laminate containers/components. They may be combinations of different materials/components (e.g. syringes,
aerosol valves).
NOTE 2 Primary packaging materials with limited contact, e.g. pipettes and syringes, are included within the scope of
this International Standard.
NOTE 3 Primary packaging materials may be directly printed or decorated.
3.35.2
secondary packaging materials
non-contact packaging materials, which include printed or unprinted cartons, labels, leaflets or inserts (or
outserts), over-wraps, and transit containers such as folding boxes
ISO 15378:2011(E)
3.36
process aids
material used to facilitate process realization
NOTE The material is not included in the product specification and can be removed at or before the final processing
stage.
EXAMPLES Mould release agents, compressed air, rolling lubricants.
3.37
production
processes resulting in primary packaging material (3.35.1)
NOTE The processes form the full production cycle, from receipt of starting materials through processing and
packaging, to completion as a finished product.
3.38
qualification process
process to demonstrate the ability to fulfil specified requirements
[ISO 9000:2005, 3.8.6]
NOTE Qualification and validation (see 3.64) comprise design qualification (DQ), installation qualification (IQ),
operational qualification (OQ), site acceptance tests (SAT) and performance qualification as well as re-qualification and
re-validation as appropriate. This activity can also be performed concurrently, by bracketing (matrix validation) and/or
retrospectively.
3.39
quality control
part of quality management focused on fulfilling quality requirements
[ISO 9000:2005, 3.2.10]
NOTE Quality control includes checking or testing that specifications are met.
3.40
quality critical
parameter affecting primary packaging material (3.35.1) quality
NOTE A material, process step or process condition, test requirement or any other relevant parameter can be
considered to be quality critical if nonconformity to its requirements could have significant detrimental consequences.
3.41
quality unit
organizational unit which fulfils both quality assurance (QA) and quality control (QC) responsibilities
NOTE The quality unit(s) may consist of separate QA and QC units or of a single individual (or group), depending
upon the size and structure of the organization.
3.42
quarantine
status of materials or products isolated pending a decision on their subsequent approval or rejection
NOTE Quarantined material is typically isolated by physical or other effective means.
3.43
realization
generic term which covers all processes required to achieve the desired output from design to product delivery
8 © ISO 2011 – All rights reserved

ISO 15378:2011(E)
3.44
reconciliation
comparison between the amount of finished product (3.23) theoretically and actually produced or used,
making allowance for normal variation
NOTE The comparison considers waste, samples or other losses inherent in the process.
3.45
reconditioning
processing or reprocessing primary packaging material to meet specification requirements
3.46
rejected
status of starting materials (3.59), process aids (3.36), intermediate products (3.27) or finished products
(3.23) whose test results do not comply with one or more of the requirements of the specification (3.57), and
which have been deemed, usually by the quality unit(s) (3.41), as not suitable for use
3.47
rejection
process whereby starting materials (3.59), process aids (3.36), intermediate products (3.27) or finished
products (3.23) which have been deemed, usually by the quality unit(s) (3.41), as not suitable for use
3.48
reprocessing
repeating part of a production process
NOTE Continuation of part of a process after an in-process control test has shown that the part is incomplete, is
considered to be part of the normal process, and is not considered reprocessing.
3.49
retained samples
materials or finished products (3.23) stored for future reference
NOTE These samples are generally taken in a sufficient amount and stored under recommended conditions for
reference during a defined period of time.
3.50
return
process for sending back primary packaging material(s) (3.35.1) to the organization (3.31)
3.51
rework
action on a nonconforming product to make it conform to the requirements
[ISO 9000:2005, 3.6.7]
NOTE Sorting can be considered to be rework.
3.52
risk analysis
systematic use of available inf
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