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BIO 221 REGULATORY COMPLIANCE IN BIOMANUFACTURING

BIO 221 REGULATORY COMPLIANCE IN BIOMANUFACTURING . CHAPTER SUMMARIES. DRUGS. BIOLOGICS. MEDICAL DEVICES. CHAPTER 1 - THE HISTORY OF THE DEVELOPMENT OF REGULATORY AGENCIES. State versus Federal Powers and the Regulation of Commerce. Georgia State Capitol. Versus.

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BIO 221 REGULATORY COMPLIANCE IN BIOMANUFACTURING

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  1. BIO 221 REGULATORY COMPLIANCE IN BIOMANUFACTURING CHAPTER SUMMARIES

  2. DRUGS BIOLOGICS MEDICAL DEVICES

  3. CHAPTER 1 - THE HISTORY OF THE DEVELOPMENT OF REGULATORY AGENCIES • State versus Federal Powers and the Regulation of Commerce

  4. Georgia State Capitol Versus The United States Capitol

  5. CHAPTER 1 - CONTINUED • The United States is a federal system of government with powers divided between the states and the federal government. • The United States Constitution grants to the federal government the power to regulate international and interstate commerce. Hence food and drug laws require that the product, or at least one of its ingredients, travel in interstate commerce.

  6. CHAPTER 1-CONTINUED • Separation of Powers

  7. CHAPTER 1-CONTINUED • History of Key Regulatory Agencies and Legislation Underpinning Regulation • USDA (formed in 1862), FDA (formed in 1931) & EPA (formed in 1970).

  8. CHAPTER 2 - EVOLUTION AND SCOPE OF THE FDA • FDA History • Basic timeline: 1848-1968 • Events and Legislation Underlying the Evolution and Scope of the FDA Drug Importation Act (1848)>>>> Bioterrorism Act (2002)

  9. CHAPTER 2 - CONTINUED • What the FDA Regulates • Food

  10. CHAPTER 2 - CONTINUED • What the FDA Regulates – Continued • Drugs

  11. CHAPTER 2 - CONTINUED • What the FDA Regulates – Continued • Medical Devices E.g. Contact Lenses

  12. CHAPTER 2 - CONTINUED • What the FDA Regulates – Continued • Biologics • Veterinary Products

  13. CHAPTER 2 - CONTINUED • What the FDA Regulates – Continued • Cosmetics

  14. CHAPTER 2 - CONTINUED • What the FDA Regulates – Continued • Radiation-Emitting Products • What the FDA Does Not Regulate

  15. CHAPTER 2 - CONTINUED • Summary of the Mission and Fundamental Activities of the FDA FDA Website: http://www.fda.gov/

  16. CHAPTER 3 - ORGANIZATION OF THE FDA • Background FDA is a federal science-based law enforcement agency within the US Department of Health and Human Services (HHS) • Organization FDA consists of six centers and several offices

  17. CHAPTER 4 - PROCESS OF DRUG DEVELOPMENT • Introduction Definition of new drug • Requirements • Preclinical Investigation • IND • Phase I clinical trials • Phase II clinical trials • Phase III clinical trials • NDA

  18. CHAPTER 4 - CONTINUED • Notes • Biologics (BLA vs NDA; CDER or CBER): • Vaccines, antitoxins, sera, blood and blood products. • Therapeutic protein drugs derived from natural sources, e.g. anti-thrombin III, or biotechnology, e.g. proteins derived using recombinant DNA technology. • Gene or somatic cell therapies.

  19. CHAPTER 5 - FORMAT, ASSEMBLY AND SUBMISSION OF IND • Introduction A submission to the FDA that requests permission to initiate a clinical study of a new drug in the United States • Requirement for an IND New drug or change in use of old drug

  20. CHAPTER 5 - CONTINUED • Pre-IND Meeting Between sponsor and FDA • Format of an IND • Assembly and Submission of an IND • Overview of Review Process

  21. CHAPTER 6 - FORMATTING, ASSEMBLING AND SUBMITTING THE NEW DRUG APPLICATION (NDA) • Introduction Approval of NDA (BLA for biologics) required for marketing and sale of drug • Format, Assembly and Submission of NDA

  22. CHAPTER 6 - CONTINUED • Overview of Review Process NDA Review Chart The New Drug Development Process: Steps from Test Tube to New Drug Application Review

  23. CHAPTER 7 – MEDICAL DEVICES

  24. CHAPTER 7 – CONTINUED • Introduction • Classification of a Medical Device • Regulatory Requirements for Medical Devices

  25. CHAPTER 8 - MEETING WITH FDA • Introduction • Types of FDA Meetings • Categories of FDA Meetings Type A, Type B and Type C • Preparing for FDA Meetings • Conduct at FDA Meetings

  26. CHAPTER 9 - GOOD CLINICAL PRACTICES • Introduction • Regulations and Guidance for GCPs

  27. CHAPTER 10 - THE ROLE OF GOOD MANUFACTURING PRACTICES • Introduction • Regulations for Good Manufacturing Practices (GMP) • Current Good Manufacturing Practices (cGMP) • Regulations • Basis • Code of Federal Regulations (CFR)

  28. CHAPTER 11 - POST-MARKETING REGULATION • Adverse drug reports are required to be reported to FDA • Post-Marketing Surveillance is an ongoing process by FDA for monitoring the safety of medical products • MedWatch, the FDA Medical Products Reporting Program, was established to facilitate post-marketing surveillance

  29. CHAPTER 12 - FDA INSPECTION AND WARNING LETTERS • Inspection: investigators look for evidence of non-compliance with • Various types of inspections • Documentation: 482, 483, 484, EIR • Warning Letters cGMP

  30. CHAPTER 13 - RISK-BASED APPROACH TO FDA REGULATION OF GMP • GMP regulations broad and open to some interpretation • Risk-based approach • Initiative: Pharmaceutical Quality for the 21st Century: A Risk-Based Approach

  31. CHAPTER 14 – PATENTS AND THEIR ROLE IN DISCOVERY AND MARKETING • The Patent • How an Invention is Patentable • The Role of Patents

  32. CHAPTER 15 - APPLICATION OF CURRENT GOOD MANUFACTURING PRACTICES • Introduction • CGMP Procedures

  33. CHAPTER 16 - BUILDINGS AND FACILITIES FOR GMP • Design and Construction

  34. CHAPTER 16 - CONTINUED • Plant Materials

  35. CHAPTER 16 - CONTINUED • Ventilation, Air Filtration; Air Heating and Cooling

  36. CHAPTER 16 - CONTINUED • Plumbing • Lighting • Sewage and Refuse • Sanitation • Maintenance

  37. CHAPTER 17 - RECEIVING AND QUARANTINE OPERATIONS • Introduction • General Requirements • Receipt and Storage of Untested Components, Drug Product Containers and Closures • Testing and Approval or Rejection of Components, Drug Product Containers and Closures

  38. CHAPTER 17 - CONTINUED • Use of Approved Components, Drug Product Containers, and Closures

  39. CHAPTER 17 - CONTINUED • Retesting of Approved Components, Drug Product Containers, and Closures • Rejected Components, Drug Product Containers, and Closures • Drug Product Containers and Closures

  40. CHAPTER 18 - CLEAN ROOMS • Introduction • Design

  41. CHAPTER 19 - EQUIPMENT PREPARATION AND ASSEMBLY • Introduction • Equipment Cleaning • Sanitary Versus Non-Sanitary Fittings • Notes on Selected Equipment

  42. CHAPTER 20 - CLEANING, DECONTAMINATION AND SANITATION (CDS) • Introduction • CDS of the General Manufacturing Area • CDS of Process Equipment

  43. CHAPTER 20 - CONTINUED

  44. CHAPTER 21-STERILIZATION OF PROCESS EQUIPMENT • Introduction • Methods of Sterilization

  45. CHAPTER 21- CONTINUED • Validation • Introduction • Qualification and Validation • Equipment Controls and Instrument Calibration

  46. CHAPTER 22 - PRODUCT FORMULATION AND FILLING OPERATIONS • Introduction • Bulk Freeze-Thawing • Formulation Process • Sterile Filtration

  47. CHAPTER 22 - CONTINUED V. Filling Liquid Filling Machine with 40 to 55 Bottles/Minute Capacities and 90 to 520mL Filling Range

  48. CHAPTER 23- HOLDING AND DISTRIBUTION • Introduction • Warehousing Procedures • Distribution Procedures

  49. THE END THANK YOU!

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