All You Never Wanted to Know About GLP and GMPResearchDevelopmentManufacturingWhat is the intent of regulations?What is Quality?GLP and GMPCurrent Good Manufacturing Practices (GMP or cGMP)PowerPoint PresentationSlide 10Slide 11Slide 12Slide 13Slide 14Slide 15Slide 16Slide 17Slide 18Slide 19Slide 20Slide 21Current Good Manufacturing PracticesPart 210: General ProvisionsSlide 24Part 211: Finished PharmaceuticalsOrganization and PersonnelBuildings and FacilitiesSlide 28EquipmentSlide 30Control of Components and Drug Product Containers and ClosuresSlide 32Slide 33Production and Process ControlsSlide 35Slide 36Packaging and Labeling ControlSlide 38Holding and DistributionLaboratory ControlsSlide 41Slide 42Slide 43Slide 44Records and ReportsSlide 46Slide 47Slide 48Slide 49Slide 50Slide 51Returned and Salvaged Drug ProductsWhat Does It All MeanSlide 54Bottom LineAll You Never Wanted to Know AboutAll You Never Wanted to Know AboutGLP and GMPGLP and GMPResearchResearchBy FDA standards . . .By FDA standards . . .A VERY uncontrolled, undisciplined activity!!!A VERY uncontrolled, undisciplined activity!!!Note: Innovation is the key.Note: Innovation is the key.DevelopmentDevelopmentBy comparison . . .By comparison . . .Much more disciplined.Much more disciplined.GLP and cGMP become considerations.GLP and cGMP become considerations.ManufacturingManufacturingMust be even more disciplined . . .Must be even more disciplined . . .cGMP takes prioritycGMP takes priorityQC becomes an important driver!QC becomes an important driver!What is the intent of regulations?What is the intent of regulations?Provide assurance of identity, quality, and strength of Provide assurance of identity, quality, and strength of pharmaceuticals.pharmaceuticals.Assure that correct procedures have been followed.Assure that correct procedures have been followed.Provide documentation, traceability.Provide documentation, traceability.Overall IntentOverall Intent::To assure To assure QualityQuality is “built in” to the approach. is “built in” to the approach.What is Quality?What is Quality?The ability to The ability to consistentlyconsistently produce the produce the samesame product to meet the product to meet the samesame specifications time specifications time after time!after time!Stronger, purer, higher assay, or higher yield . . . Stronger, purer, higher assay, or higher yield . . . is is notnot better! better!GLP and GMPGLP and GMPGMP: GMP: Protect the integrity and quality of Protect the integrity and quality of manufacturedmanufactured productproduct intended intended for for humanhuman useuse..GLP:GLP:Protect the integrity and quality of Protect the integrity and quality of laboratorylaboratory datadata used to support used to support a product application.a product application.Current Good Manufacturing Practices (GMP or cGMP)Current Good Manufacturing Practices (GMP or cGMP)Must be Must be bothboth currentcurrent andand good!good!Apply to all aspects of preparation when a drug Apply to all aspects of preparation when a drug entity is intended for use in humans (or target entity is intended for use in humans (or target animal for animal drug). animal for animal drug). Do not apply when drug is in Pre-Clinical Trials Do not apply when drug is in Pre-Clinical Trials (animal testing).(animal testing).Good Laboratory Practices (GLP)Apply when a non-clinical laboratory study Apply when a non-clinical laboratory study (e.g. Pre-Clinical animal testing) is intended to (e.g. Pre-Clinical animal testing) is intended to support an application for an FDA-regulated support an application for an FDA-regulated product.product.Good Laboratory PracticesGood Laboratory PracticesTitle 21 CFR:Title 21 CFR:Part 58: “ . . . For Non-Clinical Laboratory Studies”Part 58: “ . . . For Non-Clinical Laboratory Studies”Part 58: Non-Clinical Laboratory StudiesPart 58: Non-Clinical Laboratory StudiesPart 58: Non-Clinical Laboratory StudiesPart 58: Non-Clinical Laboratory StudiesSubpart A: General ProvisionsSubpart A: General ProvisionsSubpart B: Organization and PersonnelSubpart B: Organization and PersonnelSubpart C: FacilitiesSubpart C: FacilitiesSubpart D: EquipmentSubpart D: EquipmentSubpart E: Testing Facilities OperationSubpart E: Testing Facilities OperationSubpart F: Test and Control ArticlesSubpart F: Test and Control ArticlesSubpart G: Protocol for and Conduct of a Non-Clinical Subpart G: Protocol for and Conduct of a Non-Clinical Laboratory StudyLaboratory StudySubpart H: [Reserved]Subpart H: [Reserved]Subpart I: [Reserved]Subpart I: [Reserved]Subpart J: Records and ReportsSubpart J: Records and ReportsSubpart K: Disqualification of Testing FacilitiesSubpart K: Disqualification of Testing FacilitiesOrganization and PersonnelOrganization and Personnel58.29 Personnel58.29 Personnel (a)“Each individual engaged in the conduct of or responsible for the (a)“Each individual engaged in the conduct of or responsible for the supervision of a nonclinical laboratory study shall have supervision of a nonclinical laboratory study shall have educationeducation, , trainingtraining, and , and experienceexperience, or combination thereof, to enable that , or combination thereof, to enable that individual to perform the assigned functions.”individual to perform the assigned functions.”(b)“Each testing facility shall (b)“Each testing facility shall maintainmaintain a current a current summarysummary of of trainingtraining and and experience and job description for each individual engaged in or experience and job description for each individual engaged in or supervising the conduct of a nonclinical laboratory study.”supervising the conduct of a nonclinical laboratory study.”Organization and PersonnelOrganization and PersonnelThree Key Responsibilities:Three Key Responsibilities:Testing Facility ManagementTesting Facility ManagementStudy DirectorStudy DirectorQuality Assurance UnitQuality Assurance UnitOrganization and PersonnelOrganization and Personnel58.33 Study Director58.33 Study Director ““For each nonclinical laboratory study, a For each nonclinical laboratory study, a scientistscientist or or otherother professionalprofessional of appropriate education, training, and experience, or of appropriate education, training, and experience, or combination thereof, shall be identified as the