GOOD MANUFACTURING PRACTICES IN THE PHARMACEUTICAL, BIOTECHNOLOGY

AND MEDICAL DEVICE INDUSTRIES

MODULE 1- THE HISTORY OF THE DEVELOPMENT OF GOOD

MANUFACTURING PRACTICES (GMP)

I. State versus Federal Powers and the Regulation of Commerce

Versus

MODULE 1-CONTINUED

II. Separation of Powers

MODULE 1-CONTINUED

III. History of FDAIV. What the FDA RegulatesV. Summary of the Mission and

Fundamental Activities of the FDA

MODULE 2 - THE FDA AND PHARMACEUTICAL DEVELOPMENT

I. FDA BackgroundII. FDA OrganizationIII. Process of Drug DevelopmentIV. Notes

MODULE 3 – THE FDA AND MEDICAL DEVICES

MODULE 3 –CONTINUEDI. IntroductionII. Classification of a Medical

DeviceIII. Regulatory Requirements for

Medical Devices

MODULE 4 - ESSENTIALS OF GOOD MANUFACTURING PRACTICES

I. IntroductionII. RegulationsIII. Risk-Based Approach to FDA

Regulation of GMP

MODULE 4 - CONTINUED

IV.Further Background on Current Good Manufacturing Practices

V. CGMP ProceduresVI.FDA Inspection, Warning

Letters and Post-Marketing Regulation

MODULE 5 - BUILDINGS AND FACILITIES FOR GMP

I. Design and Construction

MODULE 5 - CONTINUED

II. Plant Materials

MODULE 5 - CONTINUED

II. Ventilation, Air Filtration; Air Heating and Cooling

MODULE 5 - CONTINUED

IV. PlumbingV. LightingVI. Sewage and RefuseVII. SanitationVIII. Maintenance 

MODULE 6 - RECEIVING AND QUARANTINE OPERATIONS

I. IntroductionII. General RequirementsIII.Receipt and Storage of Untested

Components, Drug Product Containers and Closures

IV.Testing and Approval or Rejection of Components, Drug Product Containers and Closures

MODULE 6 - CONTINUED

V. Use of Approved Components, Drug Product Containers, and Closures

MODULE 6 - CONTINUED

VI.Retesting of Approved Components, Drug Product Containers, and Closures

VII.Rejected Components, Drug Product Containers, and Closures

VIII.Drug Product Containers and Closures

MODULE 7 - HOLDING AND DISTRIBUTION

I. IntroductionII. Warehousing ProceduresIII.Distribution Procedures

MODULE 8 - QUALITY ASSURANCE AND VALIDATION

I. FUNDAMENTALSII. IMPLEMENTATION OF

VALIDATIONIII.HOW VALIDATION GETS DONEIV.PLANNING THE VALIDATION

PROJECTV. PROCESS VALIDATION

MODULE 9 - AUDITSI. IntroductionII. What is an Audit?

MODULE 9 - CONTINUED

III.What is an Internal Audit?IV.What is an External Audit?V. The Quality Systems ApproachVI.Example of a Quality AuditVII.Medical Device RegulationsVIII.Detecting Potential ProblemsIX.The Audit Program

THE ENDTHANK YOU!