GMP OrientationGMP Orientation

Presented by Presented by

Alameda ChemicalAlameda Chemical

Why GMP?Why GMP?

►ACS has decided to venture into FDA ACS has decided to venture into FDA regulated materialsregulated materials

►FDA materials are highly regulatedFDA materials are highly regulated►ACS must develop and follow strict ACS must develop and follow strict

procedures to ensure the safety and procedures to ensure the safety and integrity of the FDA regulated integrity of the FDA regulated materials under our controlmaterials under our control

►ACS must provide adequate training ACS must provide adequate training

What are GMP’s?What are GMP’s?

►GMP or Good Manufacturing Practices GMP or Good Manufacturing Practices are control measures used to ensure are control measures used to ensure the quality, safety, purity, and efficacy the quality, safety, purity, and efficacy of pharmaceutical products.of pharmaceutical products.

►GMP’s are much like our quality GMP’s are much like our quality procedures, only they are geared procedures, only they are geared toward FDA regulated materials and toward FDA regulated materials and processesprocesses

GMP Regulations and FDAGMP Regulations and FDA

►A brief review of the GMP section of A brief review of the GMP section of the FDA regulation under 21 CFR 211.the FDA regulation under 21 CFR 211.

Organization Organization and Personneland Personnel

►Responsibilities of QC UnitResponsibilities of QC Unit►Personnel ResponsibilitiesPersonnel Responsibilities►Personnel QualificationsPersonnel Qualifications►Consultants and ContractorsConsultants and Contractors

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

EquipmentEquipment

►DesignDesign►ConstructionConstruction►Cleaning and MaintenanceCleaning and Maintenance►Automatic, Mechanical, and Electronic Automatic, Mechanical, and Electronic

EquipmentEquipment►FiltersFilters

Control of Components, Drug Product Control 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

Production and Production 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

Packaging and Packaging 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

Holding and DistributionHolding and Distribution

►Storage and WarehousingStorage and Warehousing► Inventory ControlInventory Control►Environmental ControlEnvironmental Control

Laboratory ControlsLaboratory Controls

►Testing and ReleaseTesting and Release►SpecificationsSpecifications►Stability TestingStability Testing►Contamination TestingContamination Testing►Reserve SamplesReserve Samples

Records and ReportsRecords and Reports

► General RequirementsGeneral Requirements► Logs – Equipment Cleaning and UseLogs – Equipment Cleaning and Use► Component, Drug Product Container, Closure, and Component, Drug Product Container, Closure, and

Labeling Records Labeling 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 Files Complaint Files

Returned and Salvaged Drug Returned and Salvaged Drug ProductsProducts

►Returned ProductReturned Product►Salvaging Drug ProductsSalvaging Drug Products►DocumentationDocumentation►Summary:Summary:

Do it RightDo it RightDocument ItDocument ItDisclose ErrorsDisclose Errors

Contamination ControlContamination Control

►What is Contamination Control?What is Contamination Control?►Adulterated DrugsAdulterated Drugs

Types and Sources of Types and Sources of ContaminationContamination

►Food AdulterationFood Adulteration►Food Consumption RulesFood Consumption Rules►Pest ControlPest Control►Restricted Personal ItemsRestricted Personal Items►Restricted Substance ItemsRestricted Substance Items►Contamination CategoriesContamination Categories

Examples of ContaminationExamples of Contamination

►Glass ShardsGlass Shards►Metal ShardsMetal Shards►HairHair►MoldMold► BacteriaBacteria► CampylobacterCampylobacter► StreptococciStreptococci► ListeriaListeria► E. ColiE. Coli

Building and FacilitiesBuilding and Facilities

►Environmental ControlsEnvironmental Controls►CleaningCleaning►HousekeepingHousekeeping►Sewage and RefuseSewage and Refuse

Personnel ResponsibilitiesPersonnel Responsibilities

►Hand WashingHand Washing► Illness and LesionsIllness and Lesions►Clothing and GowningClothing and Gowning

Raw Materials Raw Materials and Componentsand Components

►TestingTesting►Component CleaningComponent Cleaning

Contamination SummaryContamination Summary

►QualityQuality►PurityPurity►SafetySafety►EfficacyEfficacy

Proper Documentation Proper Documentation PracticesPractices

►Regulations:Regulations:Predicate RulePredicate RuleDocumentation RetrievalDocumentation RetrievalInspection by FDAInspection by FDARetentionRetentionPreservationPreservationFormatsFormats

Required DocumentsRequired Documents

►Review Required ACS Documents here Review Required ACS Documents here once establishedonce established

Organization Organization and Personneland Personnel

► OverviewOverview Which GMP’s affect peopleWhich GMP’s affect people

► OrganizationOrganization The Quality UnitThe Quality Unit

► PersonnelPersonnel StaffingStaffing TrainingTraining Consultants and ContractorsConsultants and Contractors

► Personnel HygienePersonnel Hygiene ClothingClothing Rest RoomsRest Rooms Hand WashingHand Washing Illness and LesionsIllness and Lesions