SIST-TP CEN ISO/TR 24475:2013
(Main)Cosmetics - Good Manufacturing Practices - General training document (ISO/TR 24475:2010)
Cosmetics - Good Manufacturing Practices - General training document (ISO/TR 24475:2010)
This Technical Report is aimed at contributing to the training of personnel in cosmetic production plants within the context of the introduction of Good Manufacturing Practices and therefore does not introduce additional requirements to ISO 22716. It is intended to complement personal involvement and reasoning in the implementation of ISO 22716. This Technical Report covers the quality aspects of the cosmetic product, but does not take into account safety aspects for the personnel, nor does it cover aspects of protection of the environment or those concerning the safety and efficacy of the finished products. WARNING — This Technical Report cannot be used alone and needs as a prerequisite a good knowledge of ISO 22716 which is the reference document.
Kosmetik - Gute Herstellungspraxis (GHP) - Dokument für die allgemeine Ausbildung (ISO/TR 24475:2010)
Cosmétiques - Bonnes pratiques de fabrication - Document général de formation (ISO/TR 24475:2010)
Kozmetika - Dobra proizvodna praksa - Dokument za splošno usposabljanje (ISO/TR 24475:2010)
To tehnično poročilo je namenjeno kot pomoč pri usposabljanju osebja obratov za proizvodnjo kozmetičnih izdelkov v okviru uvajanja dobre proizvodne prakse in ne predpisuje dodatnih zahtev k standardu ISO 22716. Tehnično poročilo je namenjeno kot dopolnilo za osebno dejavno udeležbo in razumevanje pri izvajanju standarda ISO 22716. To tehnično poročilo se nanaša na vidike kakovosti kozmetičnega izdelka, vendar ne zajema vidikov varnosti zaposlenih niti ne zajema vidikov varovanja okolja oziroma vidikov, ki se nanašajo na varnost in učinkovitost končnih izdelkov. OPOZORILO – Tega tehničnega poročila ni mogoče uporabljati kot samostojni dokument, nujno je potrebno dobro poznavanje standarda ISO 22716, ki je referenčni dokument.
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Standards Content (Sample)
SLOVENSKI STANDARD
SIST-TP CEN ISO/TR 24475:2013
01-november-2013
Kozmetika - Dobra proizvodna praksa - Dokument za splošno usposabljanje
(ISO/TR 24475:2010)
Cosmetics - Good Manufacturing Practices - General training document (ISO/TR
24475:2010)
Kosmetik - Gute Herstellungspraxis (GHP) - Dokument für die allgemeine Ausbildung
(ISO/TR 24475:2010)
Cosmétiques - Bonnes pratiques de fabrication - Document général de formation
(ISO/TR 24475:2010)
Ta slovenski standard je istoveten z: CEN ISO/TR 24475:2013
ICS:
71.100.70 .R]PHWLND7RDOHWQL Cosmetics. Toiletries
SULSRPRþNL
SIST-TP CEN ISO/TR 24475:2013 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST-TP CEN ISO/TR 24475:2013
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SIST-TP CEN ISO/TR 24475:2013
TECHNICAL REPORT
CEN ISO/TR 24475
RAPPORT TECHNIQUE
TECHNISCHER BERICHT
September 2013
ICS 71.100.70
English Version
Cosmetics - Good Manufacturing Practices - General training
document (ISO/TR 24475:2010)
Cosmétiques - Bonnes pratiques de fabrication - Document Kosmetik - Gute Herstellungspraxis (GHP) - Dokument für
général de formation (ISO/TR 24475:2010) die allgemeine Ausbildung (ISO/TR 24475:2010)
This Technical Report was approved by CEN on 29 July 2013. It has been drawn up by the Technical Committee CEN/TC 392.
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
© 2013 CEN All rights of exploitation in any form and by any means reserved Ref. No. CEN ISO/TR 24475:2013: E
worldwide for CEN national Members.
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SIST-TP CEN ISO/TR 24475:2013
CEN ISO/TR 24475:2013 (E)
Contents
Page
Foreword .3
2
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SIST-TP CEN ISO/TR 24475:2013
CEN ISO/TR 24475:2013 (E)
Foreword
The text of ISO/TR 24475:2010 has been prepared by Technical Committee ISO/TC 217 "Cosmetics” of the
International Organization for Standardization (ISO) and has been taken over as CEN ISO/TR 24475:2013 by
Technical Committee CEN/TC 392 “Cosmetics” the secretariat of which is held by AFNOR.
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.
Endorsement notice
The text of ISO/TR 24475:2010 has been approved by CEN as CEN ISO/TR 24475:2013 without any
modification.
3
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SIST-TP CEN ISO/TR 24475:2013
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SIST-TP CEN ISO/TR 24475:2013
TECHNICAL ISO/TR
REPORT 24475
First edition
2010-03-01
Cosmetics — Good Manufacturing
Practices — General training document
Cosmétiques — Bonnes pratiques de fabrication — Document général
de formation
Reference number
ISO/TR 24475:2010(E)
©
ISO 2010
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SIST-TP CEN ISO/TR 24475:2013
ISO/TR 24475:2010(E)
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© ISO 2010
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
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Published in Switzerland
ii © ISO 2010 – All rights reserved
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SIST-TP CEN ISO/TR 24475:2013
ISO/TR 24475:2010(E)
Contents Page
Foreword .iv
Introduction.v
1 Scope.1
2 Personnel concerned.1
3 Content .1
3.1 Preliminary recommendations.1
3.2 General considerations.2
3.3 Quality considerations.3
3.4 The activities of Good Manufacturing Practices.4
4 Conclusion .12
Bibliography.13
© ISO 2010 – All rights reserved iii
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SIST-TP CEN ISO/TR 24475:2013
ISO/TR 24475:2010(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.
In exceptional circumstances, when a technical committee has collected data of a different kind from that
which is normally published as an International Standard (“state of the art”, for example), it may decide by a
simple majority vote of its participating members to publish a Technical Report. A Technical Report is entirely
informative in nature and does not have to be reviewed until the data it provides are considered to be no
longer valid or useful.
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/TR 24475 was prepared by Technical Committee ISO/TC 217, Cosmetics.
iv © ISO 2010 – All rights reserved
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SIST-TP CEN ISO/TR 24475:2013
ISO/TR 24475:2010(E)
Introduction
ISO 22716 was published in 2007. It is aimed at:
⎯ guiding companies with regard to their manner of organizing and conducting the activities of a plant, so as
to control the factors which may affect the quality of cosmetic products;
⎯ reaching a common and harmonized perception between companies and authorities throughout the
world;
⎯ placing at their disposal a reference document which is recognised by everyone and consistent with the
needs of globilzation of the markets.
This Technical Report has an educational purpose; it is aimed at encouraging a clearer understanding of the
training needs of ISO 22716 within the context of the practical introduction of Good Manufacturing Practices.
This Technical Report can be complemented by tools such as CD-ROMs illustrating Good Manufacturing
Practices in the cosmetic field, which can be developed in each country/region and each company showing
examples of practical scenarios, but under no circumstances can these be taken as recommendations or
requirements.
© ISO 2010 – All rights reserved v
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SIST-TP CEN ISO/TR 24475:2013
TECHNICAL REPORT ISO/TR 24475:2010(E)
Cosmetics — Good Manufacturing Practices — General training
document
1 Scope
This Technical Report is aimed at contributing to the training of personnel in cosmetic production plants within
the context of the introduction of Good Manufacturing Practices and therefore does not introduce additional
requirements to ISO 22716.
It is intended to complement personal involvement and reasoning in the implementation of ISO 22716.
This Technical Report covers the quality aspects of the cosmetic product, but does not take into account
safety aspects for the personnel, nor does it cover aspects of protection of the environment or those
concerning the safety and efficacy of the finished products.
WARNING — This Technical Report cannot be used alone and needs as a prerequisite a good
knowledge of ISO 22716 which is the reference document.
2 Personnel concerned
This Technical Report is intended for any managerial and non-managerial personnel, directly involved in the
production, control, storage and shipment of cosmetic products in the plant [manufacturing, packaging,
engineering, technical department, maintenance, receipt of the raw materials and packaging materials,
storage, shipments, quality (Quality assurance, quality control laboratories, …) but also purchasing, logistics,
administration, finance, management, human resources, cleaning personnel (contract acceptors of cleaning
personnel included)].
Temporary staff should also be taken into account in this general training.
3 Content
3.1 Preliminary recommendations
ISO 22716 subdivides the Good Manufacturing Practices into 15 key activities which cannot be considered
separately. Therefore, in order to facilitate the integration and the educational approach of these Good
Manufacturing Practices, it is recommended to tackle them according to the following three major topics.
⎯ Quality, comprised of:
⎯ quality principles;
⎯ quality control;
⎯ quality assurance and GMP.
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ISO/TR 24475:2010(E)
⎯ Justification for the existence of Good Manufacturing Practices (common data):
⎯ risks inherent to the production of cosmetic products;
⎯ elements common to the activities (personnel, premises, equipment, raw materials and packaging
materials, documentation).
⎯ Justification for the existence of Good Manufacturing Practices (specific data);
⎯ receipt and storage of the raw materials and packaging materials, sampling, release, manufacturing
operations, packaging operations, quality control laboratory, storage and shipment of the finished
products, out of specification products, wastes, subcontracting, change control, deviations, returns,
complaints and recalls, document management, internal audit.
IMPORTANT — The content of the following paragraphs can be used for the training of personnel for
example in presentations, courses, etc.
3.2 General considerations
The cosmetic industry is becoming increasingly complex due to the fact that the products face worldwide
consumer demands and global competitiveness, which generate an obligation to meet international quality
requirements.
As a consequence:
⎯ the products are more and more complex and diverse;
⎯ the technology implemented is becoming more sophisticated;
⎯ the procedures tend to become more complicated;
⎯ the economic burdens become greater.
Thus, the quality in producing the products becomes a key point of their success in the market.
It is also important to consider that the production process of cosmetic products corresponds to a complex
chain where several people are involved and several processes are implemented.
In this context, the cosmetic companies look out for any potential problem and risk that can occur during the
production process of their products:
⎯ the risk of confusion that can result from the simultaneous handling of many raw materials, packaging
materials, bulk products and finished products;
⎯ the risk of errors that can result from the number of ingredients and components introduced during the
formulation of the products;
⎯ the risk of contamination, that can result from numerous movements involving the flow of persons,
materials and products;
⎯ the risk of deterioration that can result from the improper handling and transfers of materials and
products;
⎯ the risks resulting from all other types of handling errors, for example a poorly tightened seal after a
maintenance operation or poor sealing of a container of raw materials after weighing;
⎯ the risk in the management of returned products.
2 © ISO 2010 – All rights reserved
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SIST-TP CEN ISO/TR 24475:2013
ISO/TR 24475:2010(E)
The risks mentioned above might also have a long-term impact on the cosmetic production site and on the
brand, in terms of image and finances, not to mention the health and legal perspectives. All these
considerations underline the need to implement a prevention policy shared by all and taking into account the
management of all foreseeable potential risks.
The implementation of the activities described in the Good Manufacturing Practices can significantly reduce
such potential risks.
3.3 Quality considerations
3.3.1 Quality principles
In the area of cosmetic products, the quality is defined as a set of characteristics, visible and non-visible,
established by the researchers and the development laboratories and able to be reproduced consistently. This
clearly defines in advance the characteristics which should correspond to the general requirements and
specific needs according to the market sector.
3.3.2 Quality control
See 2.13 and 9.1.2 of ISO 22716:2007.
In ISO 22716, the quality control laboratory is responsible for verifying that the quality fulfills the required
accepted defined criteria. But such controls alone cannot guarantee the quality of the production process.
This is why it remains necessary to rely on the processes implemented by the manufacturer, according to the
procedures performed by trained personnel, based on Good Manufacturing Practices for cosmetic products, in
order to guarantee that what is done is done well and that what will be done tomorrow will be identical to what
is done today.
3.3.3 Quality assurance and GMP
See Introduction and 2.27 of ISO 22716:2007.
Quality assurance is defined as the set of necessary pre-established and systematic activities put in place to
provide confidence that the products satisfy the accepted defined criteria.
GMPs constitute the practical development of the quality assurance concept, to reduce the risks, their
occurrence and to manage problems that can occur while making sure that they do not re-occur.
3.3.4 The risks inherent to the production of cosmetic products
Even when all possible precautions are taken, every activity can still generate quality defects.
Some examples can be considered to illustrate deficiencies that may occur during the production process:
⎯ referring to confusion: untidiness, non-observance of a product nomenclature, failure to follow labelling
rules, incorrect separation of flows, improper assignment of tasks to workers, all leading to the risk of
confusion, etc.;
⎯ referring to omissions: forgetting a raw material, forgetting a stage in a procedure, forgetting to note
something down, etc.;
⎯ referring to contamination: presence in the product of undesirable chemical elements, hair left uncovered
near a vessel, sneezing over an open container of raw material, handling with dirty hands, leaving outside
doors and windows open, eating near open/uncovered containers, etc.;
⎯ referring to deterioration: poor storage or transport conditions, lack of maintenance of a piece of
equipment, etc.;
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SIST-TP CEN ISO/TR 24475:2013
ISO/TR 24475:2010(E)
⎯ referring to improper implementation of procedures, etc.;
⎯ many other kinds of error may occur: poorly performed crimping control, erroneous choice of equipment
or of raw material, etc.
All of these risks impact on the quality of the products with a strong negative repercussion for the brand’s
image.
3.4 The activities of Good Manufacturing Practices
3.4.1 Personnel
See Clause 3 of ISO 22716:2007.
The personnel represent a permanent source of potential errors and contaminations and therefore need to
have undergone appropriate training in accordance with their level of responsibility. Such training has to be
adapted to the level of experience acquired and therefore should be regularly updated, evaluated and
documented. The training programme should be complemented by the hygiene programme. Personnel health
should form part of the training programme thereby ensuring that personnel that are ill or have open lesions
do not knowingly come into contact with the product. Visitors and untrained personnel should be given
information in advance before they are allowed to enter production, control and storage areas.
Together with experience, training is the key to the skills: however, one cannot learn solely through
experience, as the knowledge acquired through training helps to understand the reason for rules, to perfect
the “how to do” and, lastly, to take initiatives more successfully to improve quality.
The implementation of GMPs remains the responsibility of the management, but their application requires the
permanent participation and involvement of the personnel from all departments and at all levels.
3.4.2 Premises
See Clause 4 of ISO 22716:2007.
The premises should be designed or adapted to protect the product from contamination, whether of microbial,
physical or chemical origin. The premises should be designed to prevent the intrusion of pests, such as
insects, birds, rodents and others.
A programme to protect the premises against such pests should be implemented. For example it could consist
of laying rodent traps or substances to attract and trap insects inside the premises. Outside the premises,
measures should be taken to ensure that pests are not attracted or offered shelter.
The premises should also be well ventilated in a manner that does not allow outside contaminants to enter
through any open windows or doors. Other solutions can be implemented as long as they arrive at the same
result.
Clean and suitable washing and toilet facilities should be provided for personnel, in a differentiated location
from, but accessible to production areas.
A cleaning programme and, if necessary, a sanitization programme should be available for all areas within the
premises.
On an industrial site where hundreds of different products used for multiple activities are constantly circulating,
the risk of errors of destination and accidental mixing is not to be underestimated. For this reason sufficient
space is necessary to facilitate operations in the areas where these risks are significant, in particular at receipt,
in storage, in manufacturing and in packaging. These areas should be clearly separated from each other or
identified.
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ISO/TR 24475:2010(E)
3.4.3 Equipment
See Clause 5 of ISO 22716:2007.
It should be possible to determine, at any time, what the equipment is, what is inside, what is the batch
number. Therefore all equipment has to be correctly labelled and identifiable.
In order to ensure that a piece of equipment is used under optimum conditions, its conditions of use should be
clearly defined and controlled by trained and authorized personnel. For example, and referring to the
man
...
SLOVENSKO SIST-TP CEN ISO/TR 24475
TEHNIČNO
POROČILO november 2013
Kozmetika – Dobra proizvodna praksa – Dokument za splošno
usposabljanje (ISO/TR 24475:2010)
Cosmetics – Good Manufacturing Practices – General training document
(ISO/TR 24475:2010)
Cosmétiques – Bonnes pratiques de fabrication – Document général de formation
(ISO/TR 24475:2010)
Kosmetik - Gute Herstellungspraxis (GHP) – Dokument für die allgemeine
Ausbildung (ISO/TR 24475:2010)
Referenčna oznaka
ICS 71.100.70 SIST-TP CEN ISO/TR 24475:2013 (sl)
Nadaljevanje na straneh II in od 1 do 16
© 2013-11. Slovenski inštitut za standardizacijo. Razmnoževanje ali kopiranje celote ali delov tega standarda ni dovoljeno.
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SIST-TP CEN ISO/TR 24475 : 2013
NACIONALNI UVOD
Tehnično poročilo SIST-TP CEN ISO/TR 24475 (sl), Kozmetika – Dobra proizvodna praksa –
Dokument za splošno usposabljanje (ISO/TR 24475:2010), 2013, ima status slovenskega tehničnega
poročila in je istovetno evropskemu tehničnemu poročilu CEN ISO/TR 24475 (en), Cosmetics – Good
Manufacturing Practices – General training document (ISO/TR 24475:2010), 2013.
NACIONALNI PREDGOVOR
Mednarodno tehnično poročilo ISO/TR 24475:2010 je pripravil tehnični odbor Mednarodne
organizacije za standardizacijo ISO/TC 217 Kozmetika, evropski tehnični odbor CEN/TC 392
Kozmetika, katerega sekretariat vodi AFNOR, pa ga je privzel kot CEN ISO/TR 24475:2013.
Slovensko tehnično poročilo SIST-TP CEN ISO/TR 24475:2013 je prevod evropskega tehničnega
poročila CEN ISO/TR 24475:2013. V primeru spora glede besedila slovenskega prevoda v tem
poročilu je odločilen izvirni evropski dokument v angleškem jeziku. Slovensko izdajo tehničnega
poročila je pripravil tehnični odbor SIST/TC KDS Kozmetična, dezinfekcijska sredstva in površinsko
aktivne snovi.
Odločitev za privzem tega standarda je dne 11. oktobra 2013 sprejel tehnični odbor SIST/TC KDS
Kozmetična, dezinfekcijska sredstva in površinsko aktivne snovi.
ZVEZA S STANDARDI
S privzemom tega evropskega standarda veljajo za omenjeni namen referenčnih standardov vsi
standardi, navedeni v izvirniku, razen tistih, ki so že sprejeti v nacionalno standardizacijo:
SIST EN ISO 22716 Kozmetika – Dobra proizvodna praksa (GMP) – Smernice za dobro
proizvodno prakso (ISO 22716:2007)
OSNOVA ZA IZDAJO STANDARDA
– privzem evropskega tehničnega poročila CEN ISO/TR 24475:2013
OPOMBE
– Nacionalni uvod in nacionalni predgovor nista sestavni del standarda.
– Povsod, kjer se v besedilu standarda uporablja izraz “evropsko tehnično poročilo”, v SIST-TP
CEN ISO/TR 24475:2013 (sl) to pomeni “slovensko tehnično poročilo”.
– Ta nacionalni dokument je istoveten CEN ISO/TR 24475:2013 in je objavljen z dovoljenjem
CEN
Management Centre
Avenue Marnix 17
B-1000 Bruselj
This national document is identical with CEN ISO/TR 24475:2013 and is published with the
permission of
CEN
Management Centre
Avenue Marnix 17
B-1000 Brussels
II
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TEHNIČNO POROČILO
TECHNICAL REPORT CEN ISO/TR 24475
RAPPORT TECHNIQUE
TECHNISCHER BERICHT september 2013
ICS: 71.100.70
Slovenska izdaja
Kozmetika – Dobra proizvodna praksa – Dokument za splošno usposabljanje
(ISO/TR 24475:2010)
Cosmetics – Good Cosmétiques – Bonnes pratiques Kosmetik – Gute Herstellungspraxis
Manufacturing Practices – de fabrication – Document (GHP) – Dokument für die allgemeine
General training document général de formation (ISO/TR Ausbildung (ISO/TR 24475:2010)
(ISO/TR 24475:2010) 24475:2010)
To evropsko tehnično poročilo je CEN sprejel 29. julija 2013. Pripravil ga je tehnični odbor CEN/TC
392.
Člani CEN so nacionalni organi za standarde Avstrije, Belgije, Bolgarije, Cipra, Češke republike,
Danske, Estonije, Finske, Francije, Grčije, Hrvaške, Islandije, Irske, Italije, Latvije, Litve,
Luksemburga, Madžarske, Malte, Nizozemske, Nekdanje jugoslovanske republike Makedonije,
Nemčije, Norveške, Poljske, Portugalske, Romunije, Slovaške, Slovenije, Španije, Švedske, Švice,
Turčije in Združenega kraljestva.
CEN
Evropski komite za standardizacijo
European Committee for Standardization
Comité Européen de Normalisation
Europäisches Komitee für Normung
CEN-CENELEC Management Centre, Avenue Marnix 17, B-1000 Brussels
© 2013 CEN Lastnice avtorskih pravic so vse države članice CEN. Ref. oznaka CEN ISO/TR 24475:2013 E
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SIST-TP CEN ISO/TR 24475 : 2013
Vsebina Stran
Predgovor .3
Uvod .4
1 Področje uporabe .5
2 Osebje .5
3 Vsebina.5
3.1 Uvodna priporočila.5
3.2 Splošno.6
3.3 Kakovost.6
3.4 Aktivnosti dobre proizvodne prakse .7
4 Ugotovitve.15
Literatura.16
2
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SIST-TP CEN ISO/TR 24475 : 2013
Predgovor
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 Mednarodne 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 sprejemajo tehnični odbori, se pošljejo vsem članom v glasovanje. Za objavo
mednarodnega standarda je treba pridobiti najmanj 75 odstotkov članov, ki se udeležijo glasovanja.
V izjemnih primerih, ko tehnični odbor zbere podatke, ki so drugačni od tistih, ki se ponavadi objavijo
kot mednarodni standard (na primer "stanje tehnike"), se lahko z navadno večino glasov svojih članov,
ki se udeležijo glasovanja, odloči za objavo tehničnega poročila. Tehnično poročilo je povsem
informativne narave in ga ni treba posodobiti, dokler podatki, ki jih navaja, ne postanejo neveljavni ali
nekoristni.
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/TR 24475 je pripravil tehnični odbor ISO/TC 217 Kozmetika.
3
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SIST-TP CEN ISO/TR 24475 : 2013
Uvod
Standard ISO 22716 je bil objavljen leta 2007 z namenom:
– voditi podjetja pri organiziranju in izvajanju dejavnosti njihovega obrata tako, da je mogoče
nadzorovati dejavnike, ki lahko vplivajo na kakovost kozmetičnih izdelkov;
– doseči, da bo razumevanje podjetij in pristojnih organov po vsem svetu enotno in usklajeno;
– ponuditi referenčni dokument, ki ga priznavajo vsi in je skladen s potrebami globalizacije trgov.
To tehnično poročilo ima izobraževalni namen; njegov cilj je doseči boljše razumevanje potreb po
usposabljanju, ki jih v okviru praktičnega uvajanja dobre proizvodne prakse narekuje standard
ISO 22716. Kot dopolnilo k temu tehničnemu poročilu je mogoče uporabiti orodja, kot so CD-ROM s
prikazi dobre proizvodne prakse na področju kozmetične proizvodnje, ki se lahko razvijejo v vsaki
državi/regiji in podjetju ter ki prikazujejo primere iz prakse, vendar pa jih nikakor ni mogoče upoštevati
kot priporočila ali zahteve.
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Kozmetika – Dobra proizvodna praksa – Dokument za splošno usposabljanje
1 Področje uporabe
To tehnično poročilo je namenjeno kot pomoč pri usposabljanju osebja obratov za proizvodnjo
kozmetičnih izdelkov v okviru uvajanja dobre proizvodne prakse in ne predpisuje dodatnih zahtev k
standardu ISO 22716.
Tehnično poročilo je namenjeno kot dopolnilo za osebno dejavno udeležbo in razumevanje pri
izvajanju standarda ISO 22716.
To tehnično poročilo se nanaša na vidike kakovosti kozmetičnega izdelka, vendar ne zajema vidikov
varnosti zaposlenih niti ne zajema vidikov varovanja okolja oziroma vidikov, ki se nanašajo na varnost
in učinkovitost končnih izdelkov.
OPOZORILO – Tega tehničnega poročila ni mogoče uporabljati kot samostojni dokument,
nujno je potrebno dobro poznavanje standarda ISO 22716, ki je referenčni dokument.
2 Osebje
To tehnično poročilo je namenjeno vsem zaposlenim na vodilnih in nevodilnih delovnih mestih, ki
neposredno sodelujejo pri proizvodnji, kontroli, skladiščenju in odpremi kozmetičnih izdelkov v obratu
(proizvodnja, pakiranje, inženiring, tehnični oddelek, vzdrževanje, sprejem surovin in embalažnih
materialov, skladiščenje, odprema, kakovost (oddelek za zagotavljanje kakovosti, laboratoriji za
kontrolo kakovosti …) pa tudi nabava, logistika, administrativna podpora, finančni oddelek, vodstvo
podjetja, kadrovska služba, čistilno osebje (vključno z osebjem podpogodbenikov, ki izvaja storitve
čiščenja)).
V to splošno usposabljanje je treba vključiti tudi vse začasno zaposleno osebje.
3 Vsebina
3.1 Uvodna priporočila
Standard ISO 22716 deli dobro proizvodno prakso na 15 ključnih dejavnosti, ki jih ni mogoče
obravnavati ločeno. Zato je za lažjo uvedbo in izobraževalni pristop dobre proizvodne prakse
priporočljivo, da se dejavnosti obravnavajo v skladu z naslednjimi tremi glavnimi temami.
– kakovost, ki vključuje:
– načela kakovosti,
– obvladovanje kakovosti,
– zagotavljanje kakovosti in dobro proizvodno prakso (GMP);
– utemeljitev dobre proizvodne prakse (splošni podatki):
– tveganja, povezana s proizvodnjo kozmetičnih izdelkov,
– elementi, ki so skupni vsem dejavnostim (osebje, prostori, oprema, surovine in embalažni
materiali, dokumentacija);
– utemeljitev dobre proizvodne prakse (specifični podatki);
– sprejem in skladiščenje surovin in embalažnih materialov, vzorčenje, sproščanje, proizvodni
postopki, postopki pakiranja, laboratorij za kontrolo kakovosti, skladiščenje in odprema
končnih izdelkov, izdelki izven specifikacije, odpadki, sklepanje pogodb s podpogodbeniki,
obvladovanje sprememb, odstopanja, vračilo izdelkov, pritožbe in odpoklici, obvladovanje
dokumentov, notranja presoja.
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POMEMBNO – Vsebino naslednjih točk je mogoče uporabiti za usposabljanje osebja na primer
v okviru predstavitev, tečajev itd.
3.2 Splošno
Kozmetična industrija postaja vse bolj zapletena, kajti izdelki po vsem svetu se soočajo z zahtevami
potrošnikov in globalno konkurenčnostjo, to pa ji nalaga obveznost, da izpolnjuje mednarodne zahteve
za kakovost.
Zato:
– so izdelki bolj in bolj zahtevni in različni;
– so tehnologije, ki se uporabljajo, vse bolj izpopolnjene;
– postopki postajajo vse bolj zapleteni;
– ekonomsko breme postaja vse večje.
Kakovost v proizvodnji izdelkov je torej postala ključni dejavnik tržnega uspeha.
Upoštevati je tudi treba, da proces proizvodnje kozmetičnih izdelkov predstavlja razvejano verigo, v
kateri sodeluje veliko ljudi in se izvajajo številni procesi.
Podjetja, ki proizvajajo kozmetične izdelke, so zato zelo pozorna na morebitne težave in tveganja, do
katerih lahko pride med procesom proizvodnje njihovih izdelkov:
– tveganje zamenjav zaradi sočasne uporabe različnih surovin, embalažnih materialov, polizdelkov
in končnih izdelkov;
– tveganje napak zaradi velikega števila sestavin in sestavnih delov, ki se uporabljajo v procesu
proizvodnje izdelkov;
– tveganje onesnaženja zaradi številnih premikov, ki vključujejo pretok oseb, materialov in izdelkov;
– tveganje kvarjenja zaradi nepravilnega ravnanja ter premeščanja materialov in izdelkov;
– tveganja zaradi vseh drugih vrst napak, na primer slabo pritrjen pokrov po opravljenih
vzdrževalnih posegih ali slabo zatesnjen vsebnik s surovinami po tehtanju;
– tveganje pri obvladovanju vrnjenih izdelkov.
Navedena tveganja imajo lahko dolgoročne posledice za kozmetični proizvodni obrat in tudi za
blagovno znamko, tako z vidika ugleda in finančnega uspeha kot tudi z vidika zakonskih predpisov in
zdravja ljudi. Vse te ugotovitve poudarjajo potrebo po izvajanju politike za preprečevanje tveganj, v
katero so vključeni vsi, in po obvladovanju vseh predvidljivih morebitnih tveganj.
Z izvajanjem dejavnosti, opisanih v dobri proizvodni praksi, je mogoče ta morebitna tveganja bistveno
zmanjšati.
3.3 Kakovost
3.3.1 Načela kakovosti
Na področju kozmetičnih izdelkov je kakovost opredeljena kot niz lastnosti, vidnih ali nevidnih, ki so bile
določene v raziskovalnih in razvojnih laboratorijih in so vsak trenutek ponovljive. S tem so lastnosti, ki
morajo ustrezati splošnim zahtevam in posebnim potrebam trga, vnaprej jasno opredeljene.
3.3.2 Obvladovanje kakovosti
Glej točki 2.13 in 9.1.2 standarda ISO 22716:2007.
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V standardu ISO 22716 je laboratorij za kontrolo kakovosti odgovoren za potrditev, da kakovost
ustreza zahtevanim merilom sprejemljivosti. Vendar pa ta nadzor sam po sebi hkrati ne more
zagotoviti tudi kakovosti proizvodnega procesa.
Zato ostaja nujno zaupanje, da so procesi, ki jih izvaja proizvajalec, skladni s postopki, ki jih izvaja
usposobljeno osebje, upoštevajoč dobro proizvodno prakso za kozmetične izdelke, da bi bilo tako
zagotovljeno, da je vse, kar je narejeno, narejeno dobro in da bo vse, kar se bo delalo v prihodnje,
enako temu, kar se dela danes.
3.3.3 Zagotavljanje kakovosti in dobra proizvodna praksa
Glej uvod in točko 2.27 standarda ISO 22716:2007.
Zagotavljanje kakovosti je opredeljeno kot skupek načrtovanih in sistematičnih dejavnosti, ki so
potrebne za zagotavljanje zaupanja, da izdelek ustreza merilom sprejemljivosti.
Dobra proizvodna praksa je praktični razvoj koncepta zagotavljanja kakovosti za zmanjšanje tveganj,
prisotnosti tveganj in za obvladovanje težav, do katerih lahko pride, ter hkratno zagotavljanje, da se ne
bodo ponovile.
3.3.4 Tveganja v proizvodnji kozmetičnih izdelkov
Tudi kadar so izvedeni vsi možni previdnosti ukrepi, lahko vsaka od dejavnosti povzroči neustrezno
kakovost.
V ponazoritev pomanjkljivosti, do katerih lahko pride pri proizvodnem procesu, so v nadaljevanju
navedeni nekateri primeri, ki se nanašajo na:
– zmedo: neurejenost, neupoštevanje poimenovanja izdelkov, neupoštevanje pravil označevanja,
nepravilno ločevanje pretokov, nepravilno dodeljevanje nalog delavcem, vse, kar povzroča
tveganje zmede, itd.;
– opustitev zaradi pozabljivosti: ni bila dodana surovina, izpuščena je bila faza v postopku, podatek
ni bil zapisan itd.;
– onesnaženje: prisotnost neželenih kemičnih snovi v izdelku, nepokriti lasje, kihanje ob odprtem
vsebniku s surovino, opravljanje dela z umazanimi rokami, odprta zunanja vrata in okna, uživanje
hrane ob odprtih/nepokritih vsebnikih itd.;
– kvarjenje: slabi pogoji skladiščenja ali transporta, pomanjkljivo vzdrževanje posameznega dela
opreme itd.;
– nepravilno izvajanje postopkov itd.;
– številne druge napake: slaba kontrola glede zapiranja kovinske embalaže, napačna izbira opreme
ali surovine itd.
Vsa ta tveganja vplivajo na kakovost izdelkov in imajo zelo negativne posledice za ugled blagovne
znamke.
3.4 Aktivnosti dobre proizvodne prakse
3.4.1 Osebje
Glej točko 3 standarda ISO 22716:2007.
Osebje je stalen vir možnih napak in onesnaženj ter se mora zato udeležiti ustreznega usposabljanja v
skladu s stopnjo svoje odgovornosti. Usposabljanje mora biti prilagojeno pridobljenim izkušnjam, zato
ga je treba redno posodabljati, vrednotiti in dokumentirati. Program usposabljanja mora vključevati tudi
higienski program. Zdravje osebja mora biti sestavni del programa usposabljanja, s čimer se zagotovi,
da osebe, ki so bolne ali imajo odprte rane, namerno ne pridejo v stik z izdelkom. Preden je
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obiskovalcem in neusposobljenemu osebju dovoljen vstop v območje proizvodnje, nadzora in
skladiščenja, jih je treba ustrezno poučiti.
Usposabljanje skupaj z izkušnjami je ključnega pomena za pridobitev veščin: vendar pa se ni mogoče
učiti zgolj na podlagi izkušenj; znanje, ki je pridobljeno pri usposabljanju, je v pomoč pri razumevanju
vzrokov za pravila, izpopolnjevanju pravilnega načina dela in končno tudi pri uspešnejšem
prevzemanju pobud za izboljšanje kakovosti.
Za izvajanje dobre proizvodne prakse je še vedno odgovorno vodstvo, potrebni pa sta tudi nenehna
dejavna udeležba in zavezanost osebja v vseh oddelkih in na vseh ravneh podjetja.
3.4.2 Prostori
Glej točko 4 standarda ISO 22716:2007.
Prostori morajo biti načrtovani ali prilagojeni tako, da zagotavljajo zaščito izdelka pred vsakršnim
mikrobiološkim, fizičnim ali kemičnim onesnaženjem. Prostori morajo biti načrtovani tako, da
onemogočajo dostop insektom, pticam, glodavcem in drugim škodljivcem.
Izvajati je treba program, ki zagotavlja zaščito prostorov pred tovrstnimi škodljivci. V notranjih prostorih
se lahko v ta namen nastavijo pasti za glodavce ali snovi za privabljanje insektov v pasti. Za zunanje
prostore je treba uvesti ustrezne ukrepe, da se prepreči privabljanje ali zadrževanje škodljivcev.
Prostori morajo biti tudi dobro prezračevani, in to na način, ki ne omogoča zunanjim onesnaževalcem
vstopiti v prostore skozi odprta okna ali vrata. Mogoče so tudi druge rešitve, če zagotavljajo enak
učinek.
Osebju morajo biti na voljo čiste in ustrezne umivalnice in toaletni prostori, ki morajo biti ločeni od
proizvodnih prostorov, vendar iz njih dostopni.
Za vsako posamezno območje znotraj prostorov mora biti na voljo program čiščenja, in če je potrebno,
tudi program razkuževanja.
Na industrijski lokaciji, kjer nenehno kroži na stotine različnih izdelkov, ki se uporabljajo za
najrazličnejše dejavnosti, ni podcenjevati tveganja napačnih namembnih krajev in naključnega
pomešanja. Zato mora biti v območjih, kjer obstaja velika verjetnost tovrstnih tveganj, še zlasti pa v
območjih za sprejem, skladiščenje, proizvodnjo in pakiranje, na voljo dovolj prostora za opravljanje
dela. Ta območja morajo biti jasno ločena ali označena.
3.4.3 Oprema
Glej točko 5 standarda ISO 22716:2007.
V vsakem trenutku mora biti mogoče določiti, za katero opremo gre, kaj je v njej, za katero številko
serije gre. Zato mora biti vsa oprema pravilno označena in prepoznavna.
Da se zagotovi, da se vsak del opreme uporablja pod najboljšimi pogoji, morajo biti pogoji uporabe
jasno določeni, nadzorovati pa jih mora usposobljeno in pooblaščeno osebje. Na primer, parametri, ki
se nanašajo na proizvodnjo ali pakiranje, so temperatura, tlak, hitrost, trajanje itd.
Prav tako morajo mešalne posode omogočati zatesnitev, da so izdelki zaščiteni pred prahom in
zračno vlago, material, iz katerega je oprema izdelana, pa ne sme medsebojno reagirati z izdelkom ali
s čistilnim sredstvom.
Če so prisotne hrapave površine ali nedos
...
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