2. Why GMP?Why GMP?
►ACS has decided to venture into FDAACS has decided to venture into FDA
regulated materialsregulated materials
►FDA materials are highly regulatedFDA materials are highly regulated
►ACS must develop and follow strictACS must develop and follow strict
procedures to ensure the safety andprocedures to ensure the safety and
integrity of the FDA regulated materialsintegrity of the FDA regulated materials
under our controlunder our control
►ACS must provide adequate trainingACS must provide adequate training
3. What are GMP’s?What are GMP’s?
►GMP or Good Manufacturing Practices areGMP or Good Manufacturing Practices are
control measures used to ensure thecontrol measures used to ensure the
quality, safety, purity, and efficacy ofquality, safety, purity, and efficacy of
pharmaceutical products.pharmaceutical products.
►GMP’s are much like our qualityGMP’s are much like our quality
procedures, only they are geared towardprocedures, only they are geared toward
FDA regulated materials and processesFDA regulated materials and processes
4. GMP Regulations and FDAGMP Regulations and FDA
►A brief review of the GMP section of theA brief review of the GMP section of the
FDA regulation under 21 CFR 211.FDA regulation under 21 CFR 211.
6. Buildings and FacilitiesBuildings and Facilities
►SpaceSpace
►LightingLighting
►HVACHVAC
►Plumbing and WaterPlumbing and Water
►Sewage and RefuseSewage and Refuse
►Toileting FacilitiesToileting Facilities
►Sanitation and MaintenanceSanitation and Maintenance
8. Control of Components, Drug ProductControl of Components, Drug Product
Containers, and ClosuresContainers, and Closures
►ReceiptReceipt
►TestingTesting
►UseUse
►StorageStorage
►Rejected Materials and RetestingRejected Materials and Retesting
►RequirementsRequirements
►Drug Product Containers and ClosuresDrug Product Containers and Closures
9. Production andProduction and
Process ControlsProcess Controls
►Charge InCharge In
►Calculation of YieldCalculation of Yield
►Equipment IdentificationEquipment Identification
►SamplingSampling
►Time LimitationsTime Limitations
►Control of MicrobiologicalControl of Microbiological
►ContaminationContamination
►ReprocessingReprocessing
10. Packaging andPackaging and
Labeling ControlLabeling Control
►InspectionsInspections
►IssuanceIssuance
►Pre-use InspectionPre-use Inspection
►Tamper-resistant PackagingTamper-resistant Packaging
►Drug Product InspectionDrug Product Inspection
►Lot NumbersLot Numbers
►Expiration DatingExpiration Dating
11. Holding and DistributionHolding and Distribution
►Storage and WarehousingStorage and Warehousing
►Inventory ControlInventory Control
►Environmental ControlEnvironmental Control
12. Laboratory ControlsLaboratory Controls
►Testing and ReleaseTesting and Release
►SpecificationsSpecifications
►Stability TestingStability Testing
►Contamination TestingContamination Testing
►Reserve SamplesReserve Samples
13. Records and ReportsRecords and Reports
► General RequirementsGeneral Requirements
► Logs – Equipment Cleaning and UseLogs – Equipment Cleaning and Use
► Component, Drug Product Container, Closure, andComponent, Drug Product Container, Closure, and
Labeling RecordsLabeling Records
► Master Production and Control RecordMaster Production and Control Record
► Batch Production and Control RecordBatch Production and Control Record
► Production Record ReviewProduction Record Review
► Laboratory RecordsLaboratory Records
► Distribution RecordDistribution Record
► Complaint FilesComplaint Files
14. Returned and Salvaged DrugReturned and Salvaged Drug
ProductsProducts
►Returned ProductReturned Product
►Salvaging Drug ProductsSalvaging Drug Products
►DocumentationDocumentation
►Summary:Summary:
Do it RightDo it Right
Document ItDocument It
Disclose ErrorsDisclose Errors
16. Types and Sources of ContaminationTypes and Sources of Contamination
►Food AdulterationFood Adulteration
►Food Consumption RulesFood Consumption Rules
►Pest ControlPest Control
►Restricted Personal ItemsRestricted Personal Items
►Restricted Substance ItemsRestricted Substance Items
►Contamination CategoriesContamination Categories
17. Examples of ContaminationExamples of Contamination
► Glass ShardsGlass Shards
► Metal ShardsMetal Shards
► HairHair
► MoldMold
► BacteriaBacteria
► CampylobacterCampylobacter
► StreptococciStreptococci
► ListeriaListeria
► E. ColiE. Coli
18. Building and FacilitiesBuilding and Facilities
►Environmental ControlsEnvironmental Controls
►CleaningCleaning
►HousekeepingHousekeeping
►Sewage and RefuseSewage and Refuse
