SIST EN ISO 22716:2008
Cosmetics - Good Manufacturing Practices (GMP) - Guidelines on Good Manufacturing Practices (ISO 22716:2007)
Cosmetics - Good Manufacturing Practices (GMP) - Guidelines on Good Manufacturing Practices (ISO 22716:2007)
ISO 22716:2007 gives guidelines for the production, control, storage and shipment of cosmetic products.
These guidelines cover the quality aspects of the product, but as a whole do not cover safety aspects for the personnel engaged in the plant, nor do they cover aspects of protection of the environment.
The guidelines in ISO 22716:2007 are not applicable to research and development activities and distribution of finished products.
Kosmetik - Gute Herstellungspraxis (GMP) - Leitfaden zur guten Herstellungspraxis (ISO 22716:2007)
Diese Internationale Norm enthält Empfehlungen zu Herstellung, Überwachung, Lagerung und Versand von kosmetischen Mitteln.
Dieser Leitfaden behandelt die qualitätsbezogenen Produktaspekte; nicht behandelt werden die Sicherheit des im Werk beschäftigten Personals und Fragen des Umweltschutzes. Sicherheits und umweltbezogene Aspekte liegen in der Verantwortung der einzelnen Unternehmen und können lokalen Gesetzen und Bestimmungen unterliegen.
Dieser Leitfaden gilt weder für Tätigkeiten im Zusammenhang mit Forschung und Entwicklung noch für den Absatz von Endprodukten.
Cosmétiques - Bonnes pratiques de fabrication (BPF) - Lignes directrices relatives aux bonnes pratiques de fabrication (ISO 22716:2007)
L'ISO 22716:2007 donne des lignes directrices pour la production, le contrôle, le stockage et l'expédition des produits cosmétiques.
Ces lignes directrices couvrent les aspects liés à la qualité du produit mais, dans leur totalité, ne couvrent ni les aspects liés à la sécurité du personnel travaillant dans l'usine, ni les aspects liés à la protection de l'environnement. Les aspects liés à la sécurité et à l'environnement sont des responsabilités inhérentes à la société et peuvent être régis par les réglementations et les législations locales.
Ces lignes directrices ne s'appliquent ni aux activités de recherche et développement ni à la distribution des produits finis.
Kozmetika - Dobra proizvodna praksa (GMP) - Smernice za dobro proizvodno prakso (ISO 22716:2007)
Ta mednarodni standard podaja smernice za proizvodnjo, obvladovanje, skladiščenje in odpremo
kozmetičnih izdelkov. Te smernice se nanašajo na vidike kakovosti izdelka, vendar kot celota ne zajemajo vidikov varnosti zaposlenih v podjetju niti ne zajemajo vidikov varovanja okolja. Varnostni in okoljski vidiki sodijo med samoumevne odgovornosti podjetja in jih lahko urejajo lokalna zakonodaja in predpisi. Te smernice ne veljajo za dejavnosti raziskav in razvoja ter distribucijo končnih izdelkov.
General Information
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 22716:2008
01-januar-2008
Kozmetika - Dobra proizvodna praksa (GMP) - Smernice za dobro proizvodno
prakso (ISO 22716:2007)
Cosmetics - Good Manufacturing Practices (GMP) - Guidelines on Good Manufacturing
Practices (ISO 22716:2007)
Kosmetik - Gute Herstellungspraxis (GMP) - Leitfaden zur guten Herstellungspraxis (ISO
22716:2007)
Cosmétiques - Bonnes pratiques de fabrication (BPF) - Lignes directrices relatives aux
bonnes pratiques de fabrication (ISO 22716:2007)
Ta slovenski standard je istoveten z: EN ISO 22716:2007
ICS:
71.100.70 .R]PHWLND7RDOHWQL Cosmetics. Toiletries
SULSRPRþNL
SIST EN ISO 22716:2008 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 22716:2008
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SIST EN ISO 22716:2008
EUROPEAN STANDARD
EN ISO 22716
NORME EUROPÉENNE
EUROPÄISCHE NORM
November 2007
ICS 71.100.70
English Version
Cosmetics - Good Manufacturing Practices (GMP) - Guidelines
on Good Manufacturing Practices (ISO 22716:2007, Corrected
version 2008-05-15)
Cosmétiques - Bonnes pratiques de fabrication (BPF) - Kosmetik - Gute Herstellungspraxis (GMP) - Leitfaden zur
Lignes directrices relatives aux bonnes pratiques de guten Herstellungspraxis (ISO 22716:2007)
fabrication (ISO 22716:2007)
This European Standard was approved by CEN on 16 September 2007.
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European
Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national
standards may be obtained on application to the CEN-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, 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
© 2007 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 22716:2007 E
worldwide for CEN national Members.
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SIST EN ISO 22716:2008
EN ISO 22716:2007 (E)
Contents Page
Foreword .3
2
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SIST EN ISO 22716:2008
EN ISO 22716:2007 (E)
Foreword
This document (EN ISO 22716:2007, Corrected version 2008-05-15) has been prepared by Technical
Committee ISO/TC 217 "Cosmetics" in collaboration with Technical Committee CEN/TC 392 “Cosmetics” the
secretariat of which is held by AFNOR.
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 2008, and conflicting national standards shall be withdrawn at the
latest by May 2008.
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.
According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following
countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Cyprus, Czech
Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain,
Sweden, Switzerland and the United Kingdom.
Endorsement notice
The text of ISO 22716:2007, Corrected version 2008-05-15 has been approved by CEN as a EN ISO
22716:2007 without any modification.
3
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SIST EN ISO 22716:2008
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SIST EN ISO 22716:2008
INTERNATIONAL ISO
STANDARD 22716
First edition
2007-11-15
Cosmetics — Good Manufacturing
Practices (GMP) — Guidelines on Good
Manufacturing Practices
Cosmétiques — Bonnes Pratiques de Fabrication (BPF) — Lignes
directrices relatives aux Bonnes Pratiques de Fabrication
Reference number
ISO 22716:2007(E)
©
ISO 2007
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SIST EN ISO 22716:2008
ISO 22716:2007(E)
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Published in Switzerland
ii © ISO 2007 – All rights reserved
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SIST EN ISO 22716:2008
ISO 22716:2007(E)
Contents Page
Foreword. iv
Introduction . v
1 Scope .1
2 Terms and definitions .1
3 Personnel.4
4 Premises .6
5 Equipment .8
6 Raw materials and packaging materials .10
7 Production .11
8 Finished products.14
9 Quality control laboratory.15
10 Treatment of product that is out of specification.17
11 Wastes .17
12 Subcontracting.18
13 Deviations.19
14 Complaints and recalls .19
15 Change control.19
16 Internal audit .20
17 Documentation.20
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SIST EN ISO 22716:2008
ISO 22716:2007(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 22716 was prepared by Technical Committee ISO/TC 217, Cosmetics.
iv © ISO 2007 – All rights reserved
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SIST EN ISO 22716:2008
ISO 22716:2007(E)
Introduction
These guidelines are intended to provide guidance regarding Good Manufacturing Practices for cosmetic
products. These guidelines have been prepared for consideration by the cosmetic industry and take into
account the specific needs of this sector. These guidelines offer organizational and practical advice on the
management of the human, technical and administrative factors affecting product quality.
These guidelines have been written to allow them to be used following the flow of products from receipt to
shipment. Additionally, in order to clarify the way this document reaches its objectives, a ‘principle’ is added to
each major section.
Good Manufacturing Practices constitute the practical development of the quality assurance concept through
the description of the plant activities that are based on sound scientific judgement and risk assessments. The
objective of these GMP guidelines is to define the activities that enable you to obtain a product that meets
defined characteristics.
Documentation is an integral part of Good Manufacturing Practices.
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SIST EN ISO 22716:2008
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SIST EN ISO 22716:2008
INTERNATIONAL STANDARD ISO 22716:2007(E)
Cosmetics — Good Manufacturing Practices (GMP) —
Guidelines on Good Manufacturing Practices
1 Scope
This International Standard gives guidelines for the production, control, storage and shipment of cosmetic
products.
These guidelines cover the quality aspects of the product, but as a whole do not cover safety aspects for the
personnel engaged in the plant, nor do they cover aspects of protection of the environment. Safety and
environmental aspects are inherent responsibilities of the company and could be governed by local legislation
and regulation.
These guidelines are not applicable to research and development activities and distribution of finished
products.
2 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
2.1
acceptance criteria
numerical limits, ranges, or other suitable measures for acceptance of test results
2.2
audit
systematic and independent examination to determine whether quality activities and related results comply
with planned arrangements and whether these arrangements are implemented effectively and are suitable for
achieving objectives
2.3
batch
defined quantity of raw material, packaging material or product issued from one process or series of
processes so that it could be expected to be homogeneous
2.4
batch number
distinctive combination of numbers, letters and/or symbols, which specifically identifies a batch
2.5
bulk product
any product which has completed manufacturing stages up to, but not including, final packaging
2.6
calibration
set of operations that establish, under specified conditions, the relationship between values indicated by a
measuring instrument or measuring system, or values represented by a material measure, and the
corresponding known values of a reference standard
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SIST EN ISO 22716:2008
ISO 22716:2007(E)
2.7
change control
internal organization and responsibilities relative to any planned change of one or several activities covered by
the Good Manufacturing Practices in order to ensure that all the manufactured, packaged, controlled and
stored products correspond to the defined acceptance criteria
2.8
cleaning
all operations that ensure a level of cleanliness and appearance, consisting of separating and eliminating
generally visible dirt from a surface by means of the following combined factors, in variable proportions, such
as chemical action, mechanical action, temperature, duration of application
2.9
complaint
external information claiming a product does not meet defined acceptance criteria
2.10
contamination
occurrence of any undesirable matter such as chemical, physical and/or microbiological matter in the product
2.11
consumables
materials such as cleaning agents and lubricants that are used up during cleaning, sanitization or
maintenance operations
2.12
contract acceptor
person, company or external organization carrying out an operation on behalf of another person, company or
organization
2.13
control
verification that acceptance criteria are met
2.14
deviation
internal organization and responsibilities relative to the authorization to deviate from specified requirements
due to a planned or unplanned and, in any case, temporary situation concerning one or several activities
covered by the Good Manufacturing Practices
2.15
finished product
cosmetic product that has undergone all stages of production, including packaging in its final container, for
shipment
2.16
in-process control
controls performed during production in order to monitor and, if appropriate, to adjust the process to ensure
that the product meets the defined acceptance criteria
2.17
internal audit
systematic and independent examination made by competent personnel inside the company, the aim of which
is to determine whether activities covered by these guidelines and related results comply with planned
arrangements and whether these arrangements are implemented effectively and are suitable for achieving
objectives
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SIST EN ISO 22716:2008
ISO 22716:2007(E)
2.18
major equipment
equipment specified in production and laboratory documents which is considered essential to the process
2.19
maintenance
any periodic or unplanned support and verification operations designed to keep premises and equipment in
proper working condition
2.20
manufacturing operation
set of operations from the weighing of raw materials to the making of the bulk product
2.21
out-of-specification
examination, measurement or test result that does not comply with defined acceptance criteria
2.22
packaging operation
all packaging steps including filling and labelling, which a bulk product has to undergo in order to become a
finished product
2.23
packaging material
any material employed in the packaging of a cosmetic product, excluding any outer packaging used for
transportation
NOTE Packaging materials are referred to as primary or secondary according to whether or not they are intended to
be in direct contact with the product.
2.24
plant
location for production of cosmetic products
2.25
premises
physical location, buildings and supporting structures used to conduct receipt, storage, manufacturing,
packaging, control and shipment of product, raw materials and packaging materials
2.26
production
manufacturing and packaging operations
2.27
quality assurance
all those planned and systematic activities necessary to provide confidence that a product satisfies given
acceptance criteria
2.28
raw material
any substance going into or involved in the manufacturing of a bulk product
2.29
recall
decision made by a company to call back a product batch that has been put on the market
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SIST EN ISO 22716:2008
ISO 22716:2007(E)
2.30
reprocessing
re-treatment of all or part of a batch of finished product or bulk product of an unacceptable quality from a
defined stage of production so that its quality may be rendered acceptable by one or more additional
operations
2.31
return
sending finished cosmetic products which may or may not present a quality defect back to the plant
2.32
sample
one or more representative elements selected from a set to obtain information about that set
2.33
sampling
set of operations relating to the taking and preparation of samples
2.34
sanitization
operation, used to reduce undesirable micro-organisms on inert contaminated surfaces depending on the
objectives set
NOTE It is the action of reducing generally invisible contaminants from a surface.
2.35
shipment
set of operations relative to the preparation of an order and its putting in a transport vehicle
2.36
waste
any residue of a production operation, transformation or use, any substance, material, product that its holder
intends for disposal
3 Personnel
3.1 Principle
Persons involved in the implementation of the activities described in these guidelines should have appropriate
training to produce, control and store products with a defined quality.
3.2 Organization
3.2.1 Organization chart
3.2.1.1 The organizational structure should be defined in order that the organization and functioning of
the staff of the company be understandable. It should be appropriate for the size of the company and the
diversity of its products.
3.2.1.2 Each company should ensure that there are adequate staffing levels in the different scope of
activity, according to the diversity of its production.
3.2.1.3 The organization chart should show the independence, from the other units of the plant, of each
quality unit, such as quality assurance unit and quality control unit. The quality assurance and quality control
responsibilities can be undertaken by a separate quality assurance unit and a quality control unit, or they can
be undertaken by a single unit.
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SIST EN ISO 22716:2008
ISO 22716:2007(E)
3.2.2 Number of people
The company should have an adequate number of properly trained personnel with regards to the defined
activities in these guidelines.
3.3 Key responsibilities
3.3.1 Management responsibilities
3.3.1.1 The organization should be supported by the top management of the company.
3.3.1.2 The implementation of Good Manufacturing Practices should be the responsibility of top
management and should require the participation and commitment of personnel in all departments and at all
levels within the company.
3.3.1.3 Management should define and communicate the areas in which authorized personnel are
allowed to access.
3.3.2 Responsibilities of personnel
All personnel should:
a) know their position in the organizational structure;
b) know their defined responsibilities and activities;
c) have access to and comply with documents relevant to their particular responsibility scope;
d) comply with personal hygiene requirements;
e) be encouraged to report irregularities or other non-conformities which may occur at the level of their
responsibilities;
f) have adequate education training and skills to perform the assigned responsibilities and activities.
3.4 Training
3.4.1 Training and skills
Personnel involved in production, control, storage and shipment should have skills based on relevant training
and experience acquired, or any combination thereof, that are appropriate to their responsibilities and
activities.
3.4.2 Training and Good Manufacturing Practices
3.4.2.1 Appropriate Good Manufacturing Practices training relative to the defined activities of these
guidelines should be provided for all personnel.
3.4.2.2 The training needs of all personnel, regardless of level or seniority in the company, should be
identified and a corresponding training programme should be developed and implemented.
3.4.2.3 Considering the expertise and experience of the respective personnel, training courses should be
tailored to be appropriate to the jobs and responsibilities of individuals.
3.4.2.4 According to the needs and in-house resources available, training courses may be designed and
executed by the company itself or with the help of expert external organizations, if necessary.
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SIST EN ISO 22716:2008
ISO 22716:2007(E)
3.4.2.5 Training should be regarded as a constant and on-going process that is subject to regular
updates.
3.4.3 Newly recruited personnel
Besides basic training on the theory and practice of Good Manufacturing Practices, newly recruited personnel
should receive training appropriate to the duties assigned to them.
3.4.4 Personnel training evaluations
Knowledge accumulated by personnel should be evaluated during and/or after training.
3.5 Personnel hygiene and health
3.5.1 Personnel hygiene
3.5.1.1 Hygiene programmes should be established and adapted to the needs of the plant. These
requirements should be understood and followed by every person whose activities take them into production,
control and storage areas.
3.5.1.2 Personnel should be instructed to use hand washing facilities.
3.5.1.3 Every person entering production, control and storage areas should wear appropriate clothing
and protective garments to avoid contamination of cosmetic products.
3.5.1.4 Eating, drinking, chewing, smoking or the storage of food, drink or smoking materials or personal
medication in the production, control and storage areas should be avoided.
3.5.1.5 Any unhygienic practice within the production, control and storage areas or in any other area
where the product might be adversely affected should be forbidden.
3.5.2 Personnel health
Steps should be taken to ensure, as far as is practicable, that any person affected by an apparent illness or
having open lesions on the exposed body surface should be excluded from direct contact with product until
the condition is corrected or determined by medical personnel that the quality of cosmetic products will not be
compromised.
3.6 Visitors and untrained personnel
Visitors or untrained personnel should preferably not be taken into production, control and storage areas. If
this is unavoidable, they should be given information in advance, particularly about personal hygiene and the
prescribed protective clothing. They should be closely supervised.
4 Premises
4.1 Principle
4.1.1 Premises should be located, designed, constructed and utilized so as:
a) to ensure protection of the product;
b) to permit efficient cleaning, if necessary, sanitizing and maintenance;
c) to minimize the risk of mix-up of products, raw materials and packaging materials.
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SIST EN ISO 22716:2008
ISO 22716:2007(E)
4.1.2 Premises design recommendations are described in these guidelines. Design decisions should be
based on the type of cosmetic product produced, existing conditions, cleaning and, if necessary, sanitizing
measures used.
4.2 Types of area
Separate or defined areas should be provided for storage, production, quality control, ancillary, washing and
toilets.
4.3 Space
Sufficient space should be provided to facilitate operations such as receipt, storage and production.
4.4 Flow
Flow of materials, products and personnel through the building or buildings should be defined in order to
prevent mix-ups.
4.5 Floors, walls, ceilings, windows
4.5.1 Floors, walls, ceilings and windows in production areas should be designed or constructed for ease of
cleaning and, if necessary, sanitization and be kept clean and in good repair.
4.5.2 Windows should be of non-opening design where ventilation is adequate. If windows are opened to
the outside environment, they should be properly screened.
4.5.3 New construction of production areas should incorporate considerations for proper cleaning and
maintenance. Design of new construction should include smooth surfaces if appropriate and these surfaces
should allow for resistance to corrosive cleaning and sanitizing agents.
4.6 Washing and toilet facilities
Adequate, clean, washing and toilet facilities should be provided for personnel. The washing and toilet
facilities should be differentiated from, but accessible to, production areas. Adequate facilities for showering
and changing clothes should be provided when appropriate.
4.7 Lighting
4.7.1 Adequate lighting, that is sufficient for operations, should be installed in all areas.
4.7.2 Lighting should be installed in a manner to ensure containment of any debris from potential breakage.
Alternatively, measures should be taken to protect the product.
4.8 Ventilation
Ventilation should be sufficient for the intended production operations. Alternatively, specific measures should
be taken to protect the product.
4.9 Pipework, drains and ducts
4.9.1 Pipework, drains and ducts should be installed in such a manner so that drip or condensation does
not contaminate materials, products, surfaces and equipment.
4.9.2 Drains should be kept clean and should not allow back flow.
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SIST EN ISO 22716:2008
ISO 22716:2007(E)
4.9.3 Design considerations should be given to the following:
a) exposed overhead roof beams, pipes and ducts should be avoided;
b) exposed pipes should not touch walls, but be suspended from or supported by brackets, sufficiently
separated to allow thorough cleaning;
c) alternatively, specific measures should be taken to protect the product.
4.10 Cleaning and sanitization
4.10.1 Premises used for activities described in these guidelines should be maintained in a clean condition.
4.10.2 Cleaning and, if necessary, sanitization should be carried out to achieve the objective of protecting
each product.
4.10.3 Cleaning and, if necessary, sanitizing agents to be used should be specified and effective.
4.10.4 There should be cleaning and, if necessary, sanitization programmes corresponding to specific needs
of each area.
4.11 Maintenance
Premises used in activities described in these guidelines should be maintained in a good state of repair.
4.12 Consumables
Consumables used for premises should not affect the quality of the product.
4.13 Pest control
4.13.1 Premises should be designed, constructed and maintained so as to restrict access to insects, birds,
rodents, pests and other vermin.
4.13.2 There should be a pest control programme appropriate for the premises.
4.13.3 Measures should be taken to control the exterior of the premises to prevent attracting or harbouring
pests.
5 Equipment
5.1 Principle
Equipment should be suitable for the intended purpose and capable of being cleaned and, if necessary,
sanitized and maintained. This clause applies to all equipment within the scope of these guidelines. If
automated systems are introduced into activit
...
SLOVENSKI SIST EN ISO 22716
STANDARD
januar 2008
Kozmetika – Dobra proizvodna praksa (GMP) – Smernice za dobro
proizvodno prakso (ISO 22716:2007)
Cosmetics – Good Manufacturing Practices (GMP) – Guidelines on Good
Manufacturing Practices (ISO 22716:2007)
Cosmétiques – Bonnes Pratiques de Fabrication (BPF) – Lignes directrices
relatives aux Bonnes Pratiques de Fabrication (ISO 22716:2007)
Kosmetik – Gute Herstellungspraxis (GMP) – Leitfaden zur guten
Herstellungspraxis (ISO 22716:2007)
Referenčna oznaka
ICS 71.100.70 SIST EN ISO 22716:2008 (sl)
Nadaljevanje na straneh II in od 1 do 25
© 2010-10: Slovenski inštitut za standardizacijo. Razmnoževanje ali kopiranje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 22716 : 2008
NACIONALNI UVOD
Standard SIST EN ISO 22716 (sl), Kozmetika – Dobra proizvodna praksa (GMP) – Smernice za dobro
proizvodno prakso (ISO 22716:2007), 2008, ima status slovenskega standarda in je istoveten
evropskemu standardu EN ISO 22716 (en), Cosmetics – Good Manufacturing Practices (GMP) –
Guidelines on Good Manufacturing Practices (ISO 22716:2007), 2007.
NACIONALNI PREDGOVOR
Evropski standard EN ISO 22716:2007 je pripravil tehnični odbor Mednarodne organizacije za
standardizacijo ISO/TC 217 Kozmetika v sodelovanju s tehničnim odborom Evropskega komiteja za
standardizacijo CEN/SS H99 Izdelki za dom in prosti čas – Nedoločeni, katerega sekretariat vodi
CMC.
Slovenski standard SIST EN ISO 22716:2008 (sl) je prevod evropskega standarda EN ISO
22716:2007. V primeru spora glede besedila slovenskega prevoda v tem standardu je odločilen izvirni
evropski standard v angleškem jeziku. Slovensko izdajo standarda je pripravil tehnični odbor SIST/TC
KDS Kozmetična, dezinfekcijska sredstva in površinsko aktivne snovi.
Odločitev za privzem tega standarda je dne 23. oktobra 2007 sprejel tehnični odbor SIST/TC KDS
Kozmetična, dezinfekcijska sredstva in površinsko aktivne snovi.
OSNOVA ZA IZDAJO STANDARDA
– privzem evropskega standarda EN ISO 22716:2007
OPOMBE
– Nacionalni uvod in nacionalni predgovor nista sestavni del standarda.
– Povsod, kjer se v besedilu standarda uporablja izraz “evropski standard”, v SIST EN ISO
22716:2008 (sl) to pomeni “slovenski standard”.
– Ta nacionalni dokument je istoveten EN ISO 22716:2007 in je objavljen z dovoljenjem
CEN
Management Centre
rue de Stassart, 36
B-1050 Brussels
This national document is identical with EN ISO 22716:2007 and is published with the permission
of
CEN
Management Centre
rue de Stassart, 36
B-1050 Brussels
II
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EVROPSKI STANDARD EN ISO 22716
EUROPEAN STANDARD
EUROPÄISCHE NORM
NORME EUROPÉENNE november 2007
ICS: 71.100.70
Slovenska izdaja
Kozmetika – Dobra proizvodna praksa (GMP) – Smernice za dobro proizvodno
prakso (ISO 22716:2007)
Cosmetics – Good Manufacturing Cosmétiques – Bonnes Pratiques Kosmetik – Gute Herstellungspraxis
Practices (GMP) – Guidelines on de Fabrication (BPF) – Lignes (GMP) – Leitfaden zur guten
Good Manufacturing Practices directrices relatives aux Bonnes Herstellungspraxis (ISO 22716:2007)
(ISO 22716:2007) Pratiques de Fabrication (ISO
22716:2007)
Ta evropski standard je CEN sprejel 16. septembra 2007.
Člani CEN morajo izpolnjevati notranje predpise CEN/CENELEC, ki določajo pogoje, pod katerimi dobi
ta standard status nacionalnega standarda brez kakršnihkoli sprememb. Seznami najnovejših izdaj teh
nacionalnih standardov in njihovi bibliografski podatki so na voljo pri Upravnem centru CEN ali članih
CEN.
Ta evropski standard obstaja v treh izvirnih izdajah (angleški, francoski, nemški). Izdaje v drugih
jezikih, ki jih člani CEN na lastno odgovornost prevedejo in izdajo ter prijavijo pri Upravnem centru,
veljajo kot uradne izdaje.
Člani CEN so nacionalni organi za standarde Avstrije, Belgije, Bolgarije, Cipra, Češke republike,
Danske, Estonije, Finske, Francije, Grčije, Irske, Islandije, Italije, Latvije, Litve, Luksemburga,
Madžarske, Malte, Nemčije, Nizozemske, Norveške, Poljske, Portugalske, Romunije, Slovaške,
Slovenije, Španije, Švedske, Švice in Združenega kraljestva.
CEN
Evropski komite za standardizacijo
European Committee for Standardization
Europäisches Komitee für Normung
Comité Européen de Normalisation
Upravni center: rue de Stassart, 36 B-1000 Bruselj
© 2007. Lastnice avtorskih pravic so vse države članice CEN Ref. oznaka: EN ISO 22716:2007 E
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SIST EN ISO 22716 : 2008
VSEBINA Stran
Predgovor k evropskemu standardu .3
Predgovor k mednarodnemu standardu.4
Uvod .5
1 Področje uporabe .6
2 Izrazi in definicije .6
3 Osebje .9
4 Prostori .11
5 Oprema .13
6 Surovine in embalažni materiali .14
7 Proizvodnja.16
8 Končni izdelki.18
9 Laboratorij za kontrolo kakovosti.19
10 Obravnava izdelka izven specifikacije.21
11 Odpadki .21
12 Sklepanje pogodb s podpogodbeniki .22
13 Odstopanja .23
14 Pritožbe in odpoklici.23
15 Obvladovanje sprememb .23
16 Notranja presoja .24
17 Dokumentacija.24
2
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SIST EN ISO 22716 : 2008
Predgovor k evropskemu standardu
Ta dokument (EN ISO 22716:2007) je pripravil tehnični odbor ISO/TC 217 Kozmetika v sodelovanju
s tehničnim odborom CEN/SS H99 Izdelki za dom in prosti čas – Nedoločeni, katerega sekretariat
vodi CMC.
Ta evropski standard mora dobiti status nacionalnega standarda bodisi z objavo istovetnega besedila
ali z razglasitvijo najpozneje maja 2008, nasprotujoče nacionalne standarde pa je treba razveljaviti
najpozneje maja 2008.
Opozoriti velja, da so nekateri elementi tega dokumenta lahko predmet patentnih pravic. CEN
(in/ali CENELEC) ni odgovoren za ugotavljanje katere koli ali vseh takšnih patentnih pravic.
V skladu z notranjimi predpisi CEN/CENELEC so dolžne ta evropski standard privzeti nacionalne
organizacije za standarde naslednjih držav: Avstrije, Belgije, Bolgarije, Cipra, Češke republike,
Danske, Estonije, Finske, Francije, Grčije, Irske, Islandije, Italije, Latvije, Litve, Luksemburga,
Madžarske, Malte, Nemčije, Nizozemske, Norveške, Poljske, Portugalske, Romunije, Slovaške,
Slovenije, Španije, Švedske, Švice in Združenega kraljestva.
Razglasitvena objava
Besedilo standarda ISO 22716:2007 je CEN odobril kot evropski standard EN ISO 22716:2007 brez
sprememb.
3
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SIST EN ISO 22716 : 2008
Predgovor k mednarodnemu standardu
ISO (Mednarodna organizacija za standardizacijo) je svetovna zveza nacionalnih organov za standarde
(članov ISO). Mednarodne standarde ponavadi pripravljajo tehnični odbori ISO. Vsak član, ki želi delovati
na določenem področju, za katero je bil ustanovljen tehnični odbor, ima pravico biti zastopan v tem
odboru. Pri delu sodelujejo mednarodne vladne in nevladne organizacije, povezane z ISO. V vseh
zadevah, ki so povezane s standardizacijo na področju elektrotehnike, ISO tesno sodeluje z
Mednarodno elektrotehniško komisijo (IEC).
Mednarodni standardi so pripravljeni v skladu s pravili, podanimi v 2. delu Direktiv ISO/IEC.
Glavna naloga tehničnih odborov je priprava mednarodnih standardov. Osnutki mednarodnih
standardov, ki jih sprejmejo tehnični odbori, se pošljejo vsem članom v glasovanje. Za objavo
mednarodnega standarda je treba pridobiti soglasje najmanj 75 odstotkov članov, ki se udeležijo
glasovanja.
Opozoriti je treba na možnost, da je lahko nekaj elementov tega mednarodnega standarda predmet
patentnih pravic. ISO ne prevzema odgovornosti za ugotavljanje katerihkoli ali vseh takih patentnih
pravic.
ISO 22716 je pripravil tehnični odbor ISO/TC 217 Kozmetika.
4
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SIST EN ISO 22716 : 2008
Uvod
Te smernice so namenjene zagotavljanju navodil za dobro proizvodno prakso za kozmetične izdelke.
Te smernice so pripravljene za kozmetično industrijo in upoštevajo specifične potrebe tega sektorja.
Smernice ponujajo organizacijske in praktične nasvete za obvladovanje človeških, tehničnih in
administrativnih dejavnikov, ki vplivajo na kakovost proizvodnje.
Te smernice so bile napisane z namenom, da se uporabijo za sledljivost pretoka izdelkov od sprejema
do odpreme. V dodatno pojasnilo, kako ta dokument dosega svoj namen, je vsakemu glavnemu
poglavju dodano »načelo«.
Dobra proizvodna praksa je praktični razvoj koncepta zagotavljanja kakovosti s pomočjo opisanih
dejavnosti podjetja, ki temeljijo na zanesljivi znanstveni presoji in oceni tveganja. Cilj teh smernic
dobre proizvodne prakse je določiti dejavnosti, ki vam omogočajo pridobiti izdelek z določenimi
lastnostmi.
Dokumentacija je sestavni del dobre proizvodne prakse.
5
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SIST EN ISO 22716 : 2008
Kozmetika – Dobra proizvodna praksa (GMP) – Smernice za dobro proizvodno
prakso
1 Področje uporabe
Ta mednarodni standard podaja smernice za proizvodnjo, obvladovanje, skladiščenje in odpremo
kozmetičnih izdelkov.
Te smernice se nanašajo na vidike kakovosti izdelka, vendar kot celota ne zajemajo vidikov varnosti
zaposlenih v podjetju niti ne zajemajo vidikov varovanja okolja. Varnostni in okoljski vidiki sodijo med
samoumevne odgovornosti podjetja in jih lahko urejajo lokalna zakonodaja in predpisi.
Te smernice ne veljajo za dejavnosti raziskav in razvoja ter distribucijo končnih izdelkov.
2 Izrazi in definicije
V tem dokumentu so uporabljeni naslednji izrazi in definicije:
2.1
merila sprejemljivosti
numerične meje, območja ali druga ustrezna merila za sprejemljivost rezultatov preskusov
2.2
presoja
sistematičen in neodvisen pregled, s katerim se ugotavlja, ali so aktivnosti za vodenje kakovosti in z
njimi povezani rezultati v skladu z načrtovanimi ukrepi ter ali se ti ukrepi učinkovito izvajajo in so
primerni za doseganje ciljev
2.3
serija
določena količina surovine, embalažnega materiala ali izdelka, ki je bila pridobljena v enem ali več
procesih, zaradi česar se predvideva njena homogenost
2.4
številka serije
razpoznavna kombinacija številk, črk in/ali simbolov, ki natančno označuje serijo
2.5
polizdelek
vsak izdelek, pri katerem so bile zaključene vse faze proizvodnje razen končnega pakiranja
2.6
umerjanje
vsi postopki, s katerimi se pod posebnimi pogoji ugotavlja razmerje med vrednostmi, ki jih prikazuje
merilni instrument ali merilni sistem, ali vrednostmi, ki jih predstavlja opredmetena mera, ter med
odgovarjajočimi znanimi vrednostmi referenčnega standarda
2.7
obvladovanje sprememb
notranja organizacija in odgovornosti, povezane z vsemi načrtovanimi spremembami ene ali več
dejavnosti v okviru dobre proizvodne prakse, da se zagotovi, da vsi proizvedeni, pakirani, pregledani
in uskladiščeni izdelki ustrezajo določenim merilom sprejemljivosti
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2.8
čiščenje
vsi postopki za ločevanje in odstranjevanje vidnih nečistoč s površin, ki s pomočjo naslednjih v
različnih razmerjih kombiniranih dejavnikov: kemijskih in mehanskih postopkov, temperature ter časa
delovanja, zagotavljajo določeno raven čistosti
2.9
pritožba
zunanja informacija o tem, da izdelek ne ustreza določenim merilom sprejemljivosti
2.10
onesnaženje
prisotnost neželenih kemičnih in fizikalnih snovi in/ali mikrobioloških agensov v izdelku
2.11
potrošni material
materiali, kot so čistilna sredstva in maziva, ki se uporabljajo pri čistilnih, razkuževalnih ali
vzdrževalnih postopkih
2.12
podpogodbenik
oseba, podjetje ali zunanja organizacija, ki izvaja neko dejavnost v imenu druge osebe, podjetja ali
organizacije
2.13
obvladovanje
potrjevanje ustreznosti merilom sprejemljivosti
2.14
odstopanje
notranja organizacija in odgovornosti, povezane z avtorizacijo odstopanja od določenih zahtev zaradi
načrtovanih ali nenačrtovanih, vendar v vsakem primeru začasnih razmer v zvezi z eno ali več
dejavnostmi v okviru dobre proizvodne prakse
2.15
končni izdelek
kozmetični izdelek, ki je prešel vse faze proizvodnje, vključno s pakiranjem v končno embalažo, in je
pripravljen za odpremo
2.16
procesni nadzor
nadzor, ki se izvaja med proizvodnjo za spremljanje, in če je potrebno, tudi prilagajanje procesa, da se
zagotovi ustreznost izdelka določenim merilom sprejemljivosti
2.17
notranja presoja
sistematičen in neodvisen pregled, ki ga opravi usposobljeno osebje znotraj podjetja, da bi ugotovilo,
ali so dejavnosti, določene s temi smernicami, in z njimi povezani rezultati v skladu z načrtovanimi
ukrepi ter ali se ti ukrepi učinkovito izvajajo in so primerni za doseganje ciljev
2.18
glavna oprema
oprema, navedena v proizvodni in laboratorijski dokumentaciji, ki je bistvenega pomena za proces
2.19
vzdrževanje
vsaka redna ali nenačrtovana podpora in postopki potrjevanja, katerih namen je ohranjati prostore in
opremo v dobrem delovnem stanju
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SIST EN ISO 22716 : 2008
2.20
proizvodni postopki
vsi postopki od tehtanja surovin do izdelave polizdelka
2.21
izven specifikacije
rezultat pregleda, meritve ali preskusa, ki ni v skladu z določenimi merili sprejemljivosti
2.22
postopki pakiranja
vse faze pakiranja, vključno s polnjenjem in označevanjem, ki jih je treba izvesti, da polizdelek postane
končni izdelek
2.23
embalažni material
vsak material, ki se uporablja za pakiranje kozmetičnih izdelkov, razen transportne embalaže
OPOMBA: Embalažni materiali se glede na to, ali so namenjeni neposrednemu stiku z izdelkom ali temu niso namenjeni,
ločijo na primarno in sekundarno embalažo.
2.24
obrat
lokacija, kjer se proizvajajo kozmetični izdelki
2.25
prostori
fizična lokacija, stavbe in pomožni objekti, ki se uporabljajo za sprejem, skladiščenje, proizvodnjo,
pakiranje, nadzor in odpremo izdelkov, surovin in embalažnih materialov
2.26
proizvodnja
postopki proizvodnje in pakiranja
2.27
zagotavljanje kakovosti
vse načrtovane in sistematične dejavnosti, potrebne za zagotavljanje zaupanja, da izdelek izpolnjuje
dana merila sprejemljivosti
2.28
surovina
vsaka snov, ki je namenjena za proizvodnjo ali se uporablja pri proizvodnji polizdelka
2.29
odpoklic
odločitev podjetja, da umakne s trga serijo izdelka, ki je že bila dana na trg
2.30
dodelava
ponovna obdelava celotne serije ali dela serije končnega izdelka ali polizdelka neustrezne kakovosti
od določene faze naprej tako, da je kakovost izdelka po enem ali več dodatnih postopkih sprejemljiva
2.31
vračilo izdelkov
vračilo končnih kozmetičnih izdelkov, ki so ali niso ustrezne kakovosti, nazaj v obrat
2.32
vzorec
ena ali več reprezentativnih enot skupine, izbranih za pridobitev informacij o tej skupini
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2.33
vzorčenje
vsi postopki za jemanje in pripravo vzorcev
2.34
razkuževanje
postopek, uporabljen za zmanjšanje prisotnosti neželenih mikroorganizmov na inertnih onesnaženih
površinah glede na zastavljene cilje
OPOMBA: To je ukrep za zmanjšanje nevidne onesnaženosti površin.
2.35
odprema
vsi postopki za izvedbo naročila in nalaganje na transportno vozilo
2.36
odpadki
vsakršni ostanki pri proizvodnji, predelavi ali uporabi, vsaka snov, material, izdelek, ki je namenjen
temu, da se zavrže
3 Osebje
3.1 Načelo
Osebe, ki sodelujejo pri izvajanju dejavnosti, opisanih v teh smernicah, morajo biti ustrezno usposobljene
za proizvodnjo, nadzor in skladiščenje izdelkov določene kakovosti.
3.2 Organizacija
3.2.1 Organigram
3.2.1.1 Določitev organizacijske sheme je potrebna za jasno organiziranost in delovanje osebja v
podjetju. Ustrezati mora velikosti podjetja in raznovrstnosti njegovih izdelkov.
3.2.1.2 Vsako podjetje mora zagotoviti ustrezno kadrovsko zasedbo za različne dejavnosti glede na
raznolikost svoje proizvodnje.
3.2.1.3 Iz organigrama mora biti razvidna neodvisnost vsake od enot za kakovost, kot sta enota za
zagotavljanje kakovosti in enota za obvladovanje kakovosti, od drugih enot obrata. Odgovornost za
zagotavljanje in obvladovanje kakovosti lahko prevzameta ločeni enoti: enota za zagotavljanje
kakovosti in enota za obvladovanje kakovosti, lahko pa te naloge izvaja ena sama enota.
3.2.2 Število zaposlenih
Podjetje mora imeti ustrezno število pravilno usposobljenega osebja glede na dejavnosti, določene v
teh smernicah.
3.3 Glavne odgovornosti
3.3.1 Odgovornosti vodstva
3.3.1.1 Najvišje vodstvo podjetja mora podpirati organizacijsko shemo.
3.3.1.2 Za izvajanje dobre proizvodne prakse mora biti odgovorno najvišje vodstvo podjetja, potrebni
pa sta tudi dejavna udeležba in zavezanost osebja v vseh oddelkih in na vseh ravneh podjetja.
3.3.1.3 Vodstvo mora določiti in objaviti območja, ki so dostopna pooblaščenemu osebju.
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3.3.2 Odgovornosti osebja
Vse osebje mora:
a) poznati svoj položaj v organizacijski shemi;
b) poznati svoje odgovornosti in naloge;
c) imeti dostop do dokumentov, pomembnih za obseg njihovih specifičnih pristojnosti, in se po njih
ravnati;
d) izpolnjevati zahteve glede osebne higiene;
e) biti motivirano za javljanje nepravilnosti ali drugih neskladnosti, do katerih bi lahko prišlo na ravni
njihovih pristojnosti;
f) imeti ustrezno izobrazbo, usposobljenost in veščine za izvajanje dodeljenih odgovornosti in nalog.
3.4 Usposabljanje
3.4.1 Usposabljanje in veščine
Osebje, ki sodeluje pri proizvodnji, nadzoru, skladiščenju in odpremi, mora posedovati veščine,
pridobljene z ustreznim usposabljanjem in izkušnjami ali kombinacijo navedenega, ki ustrezajo
dodeljenim odgovornostim in nalogam.
3.4.2 Usposabljanje in dobra proizvodna praksa
3.4.2.1 Vsemu osebju mora biti omogočeno ustrezno usposabljanje s področja dobre proizvodne
prakse glede na dejavnosti, ki jih opredeljujejo te smernice.
3.4.2.2 Za vse osebje ne glede na hierarhični položaj v podjetju je treba ugotoviti potrebe po
usposabljanju ter razvijati in izvajati ustrezne programe usposabljanja.
3.4.2.3 Upoštevaje strokovnost in izkušnje zadevnega osebja je treba tečaje usposabljanja oblikovati
tako, da ustrezajo delovnim mestom in odgovornostim posameznikov.
3.4.2.4 Glede na potrebe in razpoložljive notranje vire lahko tečaje usposabljanja načrtuje in izvaja
podjetje samo, ali če je potrebno, s pomočjo strokovnega zunanjega izvajalca.
3.4.2.5 Usposabljanje je treba obravnavati kot stalen in trajen proces, ki se redno posodablja.
3.4.3 Novo zaposleno osebje
Poleg osnovnega teoretičnega in praktičnega usposabljanja iz dobre proizvodne prakse je treba novo
zaposleno osebje ustrezno usposobiti glede na dolžnosti, ki so mu dodeljene.
3.4.4 Ocenjevanje usposabljanja osebja
Pridobljeno znanje je treba oceniti med usposabljanjem in/ali po njem.
3.5 Higiena in zdravje osebja
3.5.1 Higiena osebja
3.5.1.1 Higienske programe je treba zasnovati in prilagoditi potrebam obrata. Te zahteve mora
razumeti in upoštevati vsaka oseba, ki zaradi svoje dejavnosti vstopa v območje proizvodnje, nadzora
in skladiščenja.
3.5.1.2 Osebje je treba poučiti o uporabi umivalnikov za umivanje rok.
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SIST EN ISO 22716 : 2008
3.5.1.3 Vsaka oseba, ki vstopa v območje proizvodnje, nadzora in skladiščenja, mora nositi ustrezna
in zaščitna oblačila, da se prepreči onesnaženje kozmetičnih izdelkov.
3.5.1.4 V območju proizvodnje, nadzora in skladiščenja se je treba izogibati uživanju hrane, pitju,
žvečenju, kajenju ter tudi shranjevanju hrane, pijače, tobačnih izdelkov in osebnih zdravil.
3.5.1.5 V območju proizvodnje, nadzora in skladiščenja in tudi povsod, kjer bi lahko prišlo do
škodljivega vpliva na izdelke, je treba prepovedati vsakršno ravnanje, ki je v nasprotju s higienskimi
zahtevami.
3.5.2 Zdravje osebja
Z ustreznimi ukrepi je treba zagotoviti, če je to mogoče, da se vsaki osebi, ki je očitno bolna ali ima
odprte rane na izpostavljeni površini telesa, prepreči neposreden stik z izdelki, dokler se stanje ne
popravi oziroma dokler zdravstveno osebje ne odloči, da stanje ne ogroža kakovosti kozmetičnih
izdelkov.
3.6 Obiskovalci in neusposobljeno osebje
Obiskovalci ali neusposobljeno osebje naj praviloma ne bi imeli dostopa v območje proizvodnje,
nadzora in skladiščenja. Če se temu ni mogoče izogniti, jih je treba vnaprej informirati, posebej še o
osebni higieni in predpisani zaščitni opremi. Treba jih je skrbno nadzorovati.
4 Prostori
4.1 Načelo
4.1.1 Prostori morajo biti locirani, načrtovani, zgrajeni in se uporabljati tako, da:
a) zagotavljajo zaščito izdelkov;
b) omogočajo učinkovito čiščenje, razkuževanje (če je to potrebno) in vzdrževanje;
c) se zmanjša tveganje, da bi se izdelki, surovine in embalažni materiali pomešali.
4.1.2 V teh smernicah so opisana priporočila za načrtovanje prostorov. Pri odločitvah glede
načrtovanja je treba upoštevati vrsto kozmetičnih izdelkov, ki se proizvajajo, obstoječe stanje,
čiščenje, in če je to potrebno, tudi uporabljene ukrepe razkuževanja.
4.2 Vrste območij
Za skladiščenje, proizvodnjo, kontrolo kakovosti, pomožne dejavnosti, umivalnice in toaletne prostore
morajo biti na voljo ločena oziroma točno določena območja.
4.3 Prostor
Za dejavnosti, kot so sprejem, skladiščenje in proizvodnja, mora biti na voljo dovolj prostora.
4.4 Pretok
Določiti je treba pretok materiala, izdelkov in osebja skozi stavbo oziroma stavbe, da ne pride do
zamenjav.
4.5 Tla, stene, stropi in okna
4.5.1 Tla, stene, stropi in okna v območju, kjer poteka proizvodnja, morajo biti načrtovani in izdelani
tako, da omogočajo enostavno čiščenje in razkuževanje (če je to potrebno), ter morajo biti čisti in
dobro vzdrževani.
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4.5.2 Okna morajo biti takšna, da se ob ustrezni ventilaciji ne odpirajo. Če se okna odpirajo v zunanje
okolje, morajo biti ustrezno zaščitena.
4.5.3 Pri novogradnji proizvodnih prostorov je treba upoštevati možnost ustreznega čiščenja in
vzdrževanja. Površine v načrtovani novogradnji, kjer je to potrebno, morajo biti gladke in odporne proti
jedkim čistilnim sredstvom in razkužilom.
4.6 Umivalnice in toaletni prostori
Osebju morajo biti na voljo ustrezne in čiste umivalnice in toaletni prostori, ki morajo biti ločeni od
proizvodnih prostorov, vendar iz njih dostopni. Če je to potrebno, morajo biti na voljo ustrezni prostori
za tuširanje in preoblačenje.
4.7 Razsvetljava
4.7.1 Vsi prostori morajo biti opremljeni z ustrezno razsvetljavo, ki mora omogočati izvajanje
dejavnosti.
4.7.2 Razsvetljava mora biti nameščena tako, da se ob morebitni poškodbi delci ne razsujejo v
prostor. V nasprotnem primeru je treba uvesti posebne ukrepe za zaščito izdelkov.
4.8 Prezračevanje
Prezračevanje mora zadoščati potrebam načrtovane proizvodnje. V nasprotnem primeru je treba
uvesti posebne ukrepe za zaščito izdelkov.
4.9 Cevovodi, odtoki in kanali
4.9.1 Cevovodi, odtoki in kanali morajo biti vgrajeni tako, da zaradi puščanja ali kondenza ne pride do
onesnaženja materialov, izdelkov, površin in opreme.
4.9.2 Odtoki morajo biti vedno očiščeni in ne smejo dopuščati povratnega toka.
4.9.3 Pri načrtovanju je treba upoštevati naslednje:
a) izogibati se je treba vidnim strešnim tramovom, cevem in kanalom;
b) vidne cevi se ne smejo dotikati sten, temveč morajo biti pritrjene z nosilci, ter dovolj oddaljene, da
omogočajo temeljito čiščenje;
c) v nasprotnem primeru je treba uvesti posebne ukrepe za zaščito izdelkov.
4.10 Čiščenje in razkuževanje
4.10.1 Prostore, ki se uporabljajo za dejavnosti, opisane v teh smernicah, je treba vzdrževati v čistem
stanju.
4.10.2 Za doseganje cilja, to je za zaščito vsakega izdelka, je treba izvajati čiščenje, in če je
potrebno, tudi razkuževanje.
4.10.3 Čistilna sredstva, in če je potrebno, tudi razkužila, ki se uporabljajo, morajo biti določena in
učinkovita.
4.10.4 Programi čiščenja, in če je potrebno, tudi razkuževanja morajo upoštevati posebne potrebe
vsakega posameznega območja.
4.11 Vzdrževanje
Prostori, ki se uporabljajo za dejavnosti, opisane v teh smernicah, morajo biti dobro vzdrževani.
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4.12 Potrošni material
Potrošni material, ki se uporablja v prostorih, ne sme vplivati na kakovost izdelkov.
4.13 Zatiranje škodljivcev
4.13.1 Prostori morajo biti načrtovani, zgrajeni in vzdrževani tako, da onemogočajo dostop insektom,
pticam, glodalcem, mrčesu in drugim škodljivcem.
4.13.2 Program za zatiranje škodljivcev mora ustrezati prostorom.
4.13.3 Uvesti je treba ukrepe za nadzor zunanjosti prostorov, da se prepreči privabljanje ali
zadrževanje škodljivcev.
5 Oprema
5.1 Načelo
Oprema mora ustrezati namenu uporabe in biti taka, da jo je mogoče očistiti, razkužiti (če je to
potrebno) in vzdrževati. Ta pogoj velja za vso opremo, ki je zajeta v teh smernicah. Če so za
dejavnosti, opisane v teh smernicah, uvedeni avtomatizirani sistemi, mora biti pri njih zagotovljeno
upoštevanje navedenih ustreznih načel.
5.2 Načrtovanje opreme
5.2.1 Proizvodna oprema mora biti načrtovana tako, da preprečuje onesnaženje izdelka.
5.2.2 Vsebniki za polizdelke morajo biti zaščiteni pred onesnaževalci iz zraka, kot sta prah in vlaga.
5.2.3 Opremo, pretočne cevi in pripomočke, ki niso v uporabi, je treba očistiti, razkužiti (če je to
potrebno) ter hraniti na suhem, zaščitene pred prahom in drugim onesnaženjem.
5.2.4 Material, iz katerega je izdelana oprema, mora biti ustrezen za izdelke ter za uporabljena čistilna
sredstva in razkužila.
5.3 Namestitev
5.3.1 Načrtovanje in namestitev opreme morata omogočati enostavno praznjenje zaradi lažjega
čiščenja in razkuževanja.
5.3.2 Oprema mora biti nameščena tako, da gibanje materiala, premične opreme in osebja ne ogroža
kakovosti.
5.3.3 Zaradi vzdrževanja in čiščenja mora biti omogočen smiseln dostop pod opremo, vanjo in okrog
nje.
5.3.4 Glavna oprema mora biti vidno označena.
5.4 Umerjanje
5.4.1 Laboratorijske in proizvodne merilne instrumente, ki so pomembni za kakovost izdelkov, je treba
redno umerjati.
5.4.2 Če rezultati umerjanja ne ustrezajo merilom sprejemljivosti, je treba take merilne instrumente
ustrezno označiti in odstraniti iz uporabe.
5.4.3 Stanje, ki ne ustreza umeritvi, je treba raziskati, da se ugotovi, ali kakor koli vpliva na kakovost
izdelkov, ter na podlagi izsledkov te raziskave uvesti ustrezne ukrepe.
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5.5 Čiščenje in razkuževanje
5.5.1 Vsa oprema mora biti vključena v ustrezni program čiščenja, in če je to potrebno, tudi
razkuževanja.
5.5.2 Čistilna sredstva in razkužila
...
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