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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!