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IKWCosmetics GMPChecklist for Self AssessmentThe German Cosmetic, Toiletry, Perfumery and DetergentAssociationPublished byThe German Cosmetic, Toiletry, Perfumery and Detergent AssociationMainzer Landstraße 5560329 Frankfurt am MainTelefax: 069 – 237631Email: info@ikw.orgwww.ikw.org2nd edition July 2009

ForewordIKW has already published guidelines for the manufacturing of cosmetic products for manyyears, together with a checklist for self-assessment based on them. Since 2007 aninternational standard ISO 22716 on Cosmetics GMP has been available, which waspublished in a German translation in 2008. The standard as well as the former IKW Guidelineon Cosmetics GMP are especially adapted to the cosmetic industry and permit animplementation in co-ordination with specific corporate needs and rules.Current cosmetics legislation provides both in Germany and in the EU amongst other thingsfor the manufacturing of cosmetic products taking into account cosmetics goodmanufacturing practices (GMP Good Manufacturing Practices). The manufacturers ofcosmetic products meet these statutory requirements if they manufacture their products inaccordance with the above-mentioned guidelines. In future the next amendment tocosmetics legislation will expressly refer to the standard DIN EN ISO 22716 in a Europeanregulation which will hence obtain a high relevance as state of the art.The Working Group “Cosmetics GMP” of IKW has revised the already existing Checklist forSelf-Assessment and oriented it towards the new standard. This Checklist can simplifynecessary self-controls for manufacturers of cosmetic products through the completenessand effectiveness of corporate Cosmetics GMP rules in their plants.In this way the Checklist is to provide orientation but should not represent a tick-off list. Itpossibly needs to be adjusted to the company and the processed products. It is alsodesigned as an honest self-assessment, not for disclosure to third parties. By way ofevidence for compliance with the provisions vis a vis third parties such as public authoritiesor customers, a document can be used which is attached as an annex.The German Cosmetic, Toiletry, Perfumeryand Detergent AssociationFrankfurt am Main, July 2009This document does not give dispensation in any case from the obligation to comply with statutory provisions.The document was prepared with great care. Nonetheless, the authors and IKW do not take over any liabilityfor the accuracy of the information, indications, recommendations or possible printing errors. It is thereforenot possible to derive any claims against the authors or against IKW concerning any consequences thereof.This does not apply if damage has been caused intentionally or grossly negligently by IKW or its vicariousagents. IKW 2009. The brochure can be adjusted to internal corporate needs. Any cuts and amendments comparedto the original version submitted by IKW are made under the sole responsibility of the persons making suchcuts and amendments. The Foreword is an integral part of the Checklist.

- ONLY FOR INTERNAL USE -Cosmetics GMPChecklist for Self AssessmentAssessed area:Company:Address:Plant / Department:Responsible Persons:Head of ManufacturingConducted by:Date:Head of Quality Assurance

Cosmetics GMPChecklist for Self AssessmentTable of Contents1) Scope of application (to be taken from standard DIN EN ISO 22716 and / or theseparate print of IKW, without questions in this Checklist)2) Terms and definitions (to be taken from standard DIN EN ISO 22716 and / or theseparate print of IKW, without questions in this checklist)3) Personnel4) Premises / manufacturing plant5) Equipment6) Raw materials and packaging materials7) Production8) Finished products9) Quality control laboratory10) Treatment of product that is out of specification11) Waste12) Subcontracting / Services and contract manufacturing13) Deviations14) Complaints and recalls15) Change control16) Internal audit17) DocumentationIForm (example) to confirm the requirements in accordance with Article 7a ofDirective 76/768/EEC (EC Cosmetics Directive)II Order form for this brochure as PDF file “Cosmetics GMP – Checklist for SelfAssessment”The basis for the content of this Checklist is the standard special print “CosmeticsGMP – Standard DIN EN ISO 22716; commented by IKW, to be obtained from Verlagfür chemische industrie H. Ziolkowski GmbH, Beethoven Straße 16, 86150 Augsburg,www.sofw.com or the original version of standard DIN EN ISO 22716 which can beobtained from Beuth-Verlag in Berlin under www.beuth.de

-FOR INTERNAL USE ONLY –ReferenceAs awholeIKW Cosmetics DesignationGMP based onISO .2.1.123.2.1.233.2.1.3Organisation chartIs an updated organisationchart available, which iscomprehensible andappropriate for the size ofthe company and thediversity of its productsAre adequate staffing levelsavailable according to therespective production in theindividual fields of activity?Does the organisation chartshow the independence ofthe quality unit (qualityassurance / quality control)from the other units of theComplied withPartlyNotNot applicableNote

ReferenceAs awhole4567IKW Cosmetics DesignationGMP based onISO 22716plant?3.2.2Is a sufficiently trainedpersonnel with regard tothe activities defined inthese guidelines available:3.2.2a- in the field of production?3.2.2b- in the field of qualitycontrol?3.2.2c- in the field of purchasing /procurement?3.2.2.d- in the field of gateway /incoming goods?3.3Key Responsibilities3.3.1ManagementresponsibilitiesIs the organisationsupported by the topmanagement of thecompany?Does the responsibility forthe implementation ofGood ManufacturingPractices lie with the top83.3.1.193.3.1.2aComplied withPartlyNotNot applicableNote

ReferenceAs awhole1011121314IKW Cosmetics DesignationGMP based onISO 22716management?3.3.1.2bDoes the top managementinvolve the personnel of alldepartments and positionsof the company in theimplementation of GoodManufacturing Practices?76/768/ECDoes the Head ofManufacturing have a basicscientific or technicaleducation?76/768/ECDoes the Head of QualityControl have a basicscientific or technicaleducation?3.3.1.3Are the areas in themanufacturing plant whichmay only be accessed byauthorised personneldefined?3.3.2Responsibilities ofPersonnel3.3.2aDoes the personnel know itsposition in theComplied withPartlyNotNot applicableNote

ReferenceAs awhole151617181920IKW Cosmetics DesignationGMP based onISO 22716organisational structure?3.3.2bDoes the personnel know itsdefined responsibilities andactivities?3.3.2cDoes the personnel haveaccess to the documentswhich are relevant for itsparticular scope ofresponsibility?3.3.2dAre the provisions of thedocuments complied with inthe respective scopes ofresponsibly?3.3.2eDoes the personnel complywith personal hygienerequirements?3.3.2fDoes the personnel reportirregularities or nonconformities within itsscope of responsibility?3.3.2gDoes the personnel haveadequate education trainingand skills to perform theassigned responsibilities andComplied withPartlyNotNot applicableNote

ReferenceAs awholeIKW Cosmetics DesignationGMP based onISO 22716activities?3.4Training3.4.13.4.2Training and SkillsTraining and GoodManufacturing PracticesIs the personnel offeredappropriate GoodManufacturing Practicestraining?Are the training needs of allpersonnel determined?Is a training programmedeveloped andimplemented on the basisof the identified trainingneeds?Is the training programmedocumented?Are the training courses ofthe respective personneltailored to be appropriateto the jobs andresponsibilities ofindividuals considering 2.3Complied withPartlyNotNot applicableNote

ReferenceAs awhole2627282930IKW Cosmetics DesignationGMP based onISO 22716expertise and experience?3.4.2.4Are the training coursesdeveloped andimplemented by internal orexternal personnel?3.4.2.5aAre trainings carried out ona regular basis and adjustedto current circumstances?3.4.2.5bAre any trainings carried outdocumented?3.4.3Is newly recruited personnelprovided with basic trainingon the theory and practiceof Good ManufacturingPractices as well as trainingappropriate to the dutiesassigned to it?3.4.4Is the knowledgeaccumulated by personnelevaluated during or aftertraining?3.5Personnel Hygiene andHealthComplied withPartlyNotNot applicableNote

ReferenceAs awhole31323334353637IKW Cosmetics DesignationGMP based onISO 227163.5.1Personnel Hygiene3.5.1.1aHas a hygiene programmebeen established for theproduction, quality controland storage areas?3.5.1.1bHas the hygiene programmebeen adapted to the needsof the plant?3.5.1.1cAre the requirementsdefined in the hygieneprogramme understood andfollowed?3.5.1.2aAre sufficient facilities forhand washing and handdisinfection available?3.5.1.2bHas the personnel beeninstructed in respect ofhand washing anddisinfection?3.5.1.2cAre the facilities for handwashing and disinfectionused?3.5.1.3aDoes the personnel wearappropriate clothing andComplied withPartlyNotNot applicableNote

ReferenceAs awhole38394041IKW Cosmetics DesignationGMP based onISO 22716protective garments toavoid contamination ofcosmetic products?3.5.1.3bDoes the quality controlpersonnel wear appropriateand prescribed clothing andprotective garments toavoid contamination ofcosmetic products?3.5.1.3cDoes the warehousepersonnel wear appropriateand prescribed clothing andprotective garments inorder to avoidcontamination of thecosmetic products?3.5.1.4aIs there a ban on eating anddrinking, chewing andsmoking in the production,quality control and storageareas?3.5.1.4bIs there a ban on storingfood, drink or smokingmaterials or personalComplied withPartlyNotNot applicableNote

ReferenceAs awhole424344IKW Cosmetics DesignationGMP based onISO 22716medication in theproduction, quality controland storage areas?3.5.1.4cIs there a provision in theproduction, quality controland storage areasconcerning the wearing of awatch and any jewellery(including a wedding ring),artificial finger nails andvisible piercings, etc?3.5.1.5Is there an instruction forthe production, qualitycontrol and storage areasforbidding any unhygienicpractice in order to avoidthe product from beingadversely affected?3.5.2Personnel Health3.5.2Have steps been taken toavoid that any personaffected by an illness orhaving open lesions isexcluded from the area ofComplied withPartlyNotNot applicableNote

ReferenceAs awholeIKW Cosmetics DesignationGMP based onISO 22716open products?3.6Visitors and UntrainedPersonnel453.6a463.6b473.6cAre visitors and untrainedpersonnel kept away fromthe production, qualitycontrol and storage areas?If it is unavoidable to keepthem away from thementioned areas, is thisgroup of persons giveninformation and supervisedin terms of personal hygieneand the prescribedprotective clothing?Is there any provision forthe conduct of visitors andthird party handicrafts inthe production and storageareas?4.Premises /Production Plan4.1PrincipleComplied withPartlyNotNot applicableNote

ReferenceAs awhole48.49505152IKW Cosmetics DesignationGMP based onISO 227164.1.1aAre the premises designed,constructed and utilised soas to ensure protection ofthe product?4.1.1bIs efficient cleaning, ifnecessary, sanitising andmaintenance of thepremises possible?4.1.1cAre the premises designed,constructed and utilised soas to minimise the risk ofconfusion when movingproducts, raw materials andpackaging materials?4.1.2Have areas of differenthygienic requirements beendefined, identified and havemeasures been assigned tothe areas?4.2Types of Area4.2Have separate or definedareas been provided forstorage, production, qualitycontrol, ancillary, washingComplied withPartlyNotNot applicableNote