ISO22716：2007標準(中英文對照SN T2359-2009)47

1、 reference numberiso 22716:2007(e) iso 2007 international standard iso22716first edition2007-11-15cosmetics good manufacturing practices (gmp) guidelines on good manufacturing practices cosmtiques bonnes pratiques de fabrication (bpf) lignes directrices relatives aux bonnes pratiques de fabrication

2、copyright international organization for standardization provided by ihs under license with iso licensee=hong kong polytechnic univ/9976803100 not for resale, 09/19/2009 22:03:41 mdtno reproduction or networking permitted without license from ihs-,-,-iso 22716:2007(e) pdf disclaimer this pdf file ma

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5、on parameters were optimized for printing. every care has been taken to ensure that the file is suitable for use by iso member bodies. in the unlikely event that a problem relating to it is found, please inform the central secretariat at the address given below. copyright protected document iso 2007

6、 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 isos member body in the count

7、ry of the requester. iso copyright office case postale 56 ch-1211 geneva 20 tel. + 41 22 749 01 11 fax + 41 22 749 09 47 e-mail web published in switzerland ii iso 2007 all rights reserved copyright international organization for standardization provided by ihs under lic

8、ense with iso licensee=hong kong polytechnic univ/9976803100 not for resale, 09/19/2009 22:03:41 mdtno reproduction or networking permitted without license from ihs-,-,-iso 22716:2007(e) iso 2007 all rights reserved iiicontents page foreword. iv introduction. v 1 scope .1 2 terms and definitions .1

9、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 ch

10、ange control.19 16 internal audit .20 17 documentation.20 copyright international organization for standardization provided by ihs under license with iso licensee=hong kong polytechnic univ/9976803100 not for resale, 09/19/2009 22:03:41 mdtno reproduction or networking permitted without license from

11、 ihs-,-,-iso 22716:2007(e) iv iso 2007 all rights reserved 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 committ

12、ees. 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 int

13、ernational 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

14、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 s

15、ubject 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. copyright international organization for standardization provided by ihs under license with iso licensee=hong kong polytechni

16、c univ/9976803100 not for resale, 09/19/2009 22:03:41 mdtno reproduction or networking permitted without license from ihs-,-,-iso 22716:2007(e) iso 2007 all rights reserved vintroduction these guidelines are intended to provide guidance regarding good manufacturing practices for cosmetic products. t

17、hese 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 guid

18、elines 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

19、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

20、an integral part of good manufacturing practices. copyright international organization for standardization provided by ihs under license with iso licensee=hong kong polytechnic univ/9976803100 not for resale, 09/19/2009 22:03:41 mdtno reproduction or networking permitted without license from ihs-,-,

21、-copyright international organization for standardization provided by ihs under license with iso licensee=hong kong polytechnic univ/9976803100 not for resale, 09/19/2009 22:03:41 mdtno reproduction or networking permitted without license from ihs-,-,-international standard iso 22716:2007(e) iso 200

22、7 all rights reserved 1cosmetics 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 a

23、s 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

24、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

25、.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 mate

26、rial 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

27、, 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 s

28、tandard copyright international organization for standardization provided by ihs under license with iso licensee=hong kong polytechnic univ/9976803100 not for resale, 09/19/2009 22:03:41 mdtno reproduction or networking permitted without license from ihs-,-,-iso 22716:2007(e) 2 iso 2007 all rights r

29、eserved 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 cr

30、iteria 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

31、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 lubric

32、ants 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 inter

33、nal 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

34、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

35、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 suitabl

36、e for achieving objectives copyright international organization for standardization provided by ihs under license with iso licensee=hong kong polytechnic univ/9976803100 not for resale, 09/19/2009 22:03:41 mdtno reproduction or networking permitted without license from ihs-,-,-iso 22716:2007(e) iso

37、2007 all rights reserved 32.18 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.

38、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

39、 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

40、 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

41、 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 th

42、e 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 copyright international organization for standardization provided by ihs under license with iso licensee=hong kong polytechnic univ/9976803100 not for resale, 09/19/2

43、009 22:03:41 mdtno reproduction or networking permitted without license from ihs-,-,-iso 22716:2007(e) 4 iso 2007 all rights reserved 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

44、 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 sampli

45、ng 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 shipme

46、nt 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 impleme

47、ntation 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 the organizational structure should be defined in order that the organization and functioning of t

48、he staff of the company be understandable. it should be appropriate for the size of the company and the diversity of its products. each company should ensure that there are adequate staffing levels in the different scope of activity, according to the diversity of its production. the

49、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 u

50、nit, or they can be undertaken by a single unit. copyright international organization for standardization provided by ihs under license with iso licensee=hong kong polytechnic univ/9976803100 not for resale, 09/19/2009 22:03:41 mdtno reproduction or networking permitted without license from ihs-,-,-

51、iso 22716:2007(e) iso 2007 all rights reserved 53.2.2 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 the organization should be su

52、pported by the top management of the company. 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. management should

53、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 r

54、elevant 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 responsib

55、ilities 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 train

56、ing and good manufacturing practices appropriate good manufacturing practices training relative to the defined activities of these guidelines should be provided for all personnel. the training needs of all personnel, regardless of level or seniority in the company, should be identifi

57、ed and a corresponding training programme should be developed and implemented. considering the expertise and experience of the respective personnel, training courses should be tailored to be appropriate to the jobs and responsibilities of individuals. according to the needs and in-ho

58、use resources available, training courses may be designed and executed by the company itself or with the help of expert external organizations, if necessary. copyright international organization for standardization provided by ihs under license with iso licensee=hong kong polytechnic univ/9976803100

59、 not for resale, 09/19/2009 22:03:41 mdtno reproduction or networking permitted without license from ihs-,-,-iso 22716:2007(e) 6 iso 2007 all rights reserved training should be regarded as a constant and on-going process that is subject to regular updates. 3.4.3 newly recruited personnel bes

60、ides 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