ABSTRACT
The Procter & Gamble Company, Cincinnati, Ohio
I. INTRODUCTION II. ORGANIZATION AND PERSONNEL
A. Organization Structure B . Personnel Qualifications C. Personal Sanitation D. Health
III. BUILDINGS AND FACILITIES IV. EQUIPMENT V. CONTROL OF RAW MATERIALS AND PACKAGING
MATERIALS A. Control Systems B. Sampling and Testing C. Storage
VI. PRODUCTION AND PROCESS CONTROLS VII. PACKAGING AND LABELING CONTROLS
VIII. WAREHOUSE AND DISTRIBUTION IX. SUMMARY X. APPENDIX: U.S. FOOD AND DRUG ADMINISTRATION
I. INTRODUCTION
The U.S. Food and Drug Administration (FDA) may be issuing Current Cosmetic Good Manufacturing Practices (CCGMP) regulations or guidelines in the future to convey their manufacturing expectations to
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thecosmeticindustry.TheFDAisresponsibleforseeing·thatcosmeticproductsarenotadulteratedormisbranded.Aspointedoutin Chap.1,"RegulationofCosmeticsintheUnitedStates-AnOverview,"theFDAisauthorizedtocheckthesanitationofacosmetic PackagingandLabelingAct.TheFDAisalsointerestedinthecompetenceofthepersonnel,thematerialcontrolsystemsused,andrecordsystemsmaintainedintheproductionofcosmetics.Itshouldbe notedthattheFDAcurrentlydoesnothaveauthoritytoexaminerecordsforcosmeticsandcosmeticdrug·swhicharealso"olddrugs"(anticariestoothpastes,antidandruffshampoos,etc.).1TheFDAdoes haveauthoritytoexaminerecordsforcosmeticswhicharealso"new drugs,n2tocheckcompliancewiththedrugs'NewDrugApplication (NDA).EventhoughtheFDAdoesnothaveauthoritytoexamine records,controlsystems,personnelqualifications,etc.,itwillask questionsduringanestablishmentinspectionrelatingtothesesubjects.Infact,theFDAhasrecentlypublishedarevisionofitsInspectors'OperationsManual,whichcontains"GMPGuidelinesforCosmetics"(seetheAppendixtothischapter).
