Gmp Orientation

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Basic orientation training to introduce employees to GMP.

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Gmp Orientation

  1. 1. GMP Orientation Presented by Alameda Chemical
  2. 2. Why GMP? ► ACS has decided to venture into FDA regulated materials ► FDA materials are highly regulated ► ACS must develop and follow strict procedures to ensure the safety and integrity of the FDA regulated materials under our control ► ACS must provide adequate training
  3. 3. What are GMP’s? ► GMP or Good Manufacturing Practices are control measures used to ensure the quality, safety, purity, and efficacy of pharmaceutical products. ► GMP’s are much like our quality procedures, only they are geared toward FDA regulated materials and processes
  4. 4. GMP Regulations and FDA ►A brief review of the GMP section of the FDA regulation under 21 CFR 211.
  5. 5. Organization and Personnel ► Responsibilities of QC Unit ► Personnel Responsibilities ► Personnel Qualifications ► Consultants and Contractors
  6. 6. Buildings and Facilities ► Space ► Lighting ► HVAC ► Plumbing and Water ► Sewage and Refuse ► Toileting Facilities ► Sanitation and Maintenance
  7. 7. Equipment ► Design ► Construction ► Cleaningand Maintenance ► Automatic, Mechanical, and Electronic Equipment ► Filters
  8. 8. Control of Components, Drug Product Containers, and Closures ► Receipt ► Testing ► Use ► Storage ► RejectedMaterials and Retesting ► Requirements ► Drug Product Containers and Closures
  9. 9. Production and Process Controls ► Charge In ► Calculation of Yield ► Equipment Identification ► Sampling ► Time Limitations ► Control of Microbiological ► Contamination ► Reprocessing
  10. 10. Packaging and Labeling Control ► Inspections ► Issuance ► Pre-use Inspection ► Tamper-resistant Packaging ► Drug Product Inspection ► Lot Numbers ► Expiration Dating
  11. 11. Holding and Distribution ► Storage and Warehousing ► Inventory Control ► Environmental Control
  12. 12. Laboratory Controls ► Testing and Release ► Specifications ► Stability Testing ► Contamination Testing ► Reserve Samples
  13. 13. Records and Reports ► General Requirements ► Logs – Equipment Cleaning and Use ► Component, Drug Product Container, Closure, and Labeling Records ► Master Production and Control Record ► Batch Production and Control Record ► Production Record Review ► Laboratory Records ► Distribution Record ► Complaint Files
  14. 14. Returned and Salvaged Drug Products ► Returned Product ► Salvaging Drug Products ► Documentation ► Summary: Do it Right Document It Disclose Errors
  15. 15. Contamination Control ► What is Contamination Control? ► Adulterated Drugs
  16. 16. Types and Sources of Contamination ► Food Adulteration ► Food Consumption Rules ► Pest Control ► Restricted Personal Items ► Restricted Substance Items ► Contamination Categories
  17. 17. Examples of Contamination ► Glass Shards ► Metal Shards ► Hair ► Mold ► Bacteria ► Campylobacter ► Streptococci ► Listeria ► E. Coli
  18. 18. Building and Facilities ► Environmental Controls ► Cleaning ► Housekeeping ► Sewage and Refuse
  19. 19. Personnel Responsibilities ► Hand Washing ► Illness and Lesions ► Clothing and Gowning
  20. 20. Raw Materials and Components ► Testing ► Component Cleaning
  21. 21. Contamination Summary ► Quality ► Purity ► Safety ► Efficacy
  22. 22. Proper Documentation Practices ► Regulations: Predicate Rule Documentation Retrieval Inspection by FDA Retention Preservation Formats
  23. 23. Required Documents ► Review Required ACS Documents here once established
  24. 24. Organization and Personnel ► Overview  Which GMP’s affect people ► Organization  The Quality Unit ► Personnel  Staffing  Training  Consultants and Contractors ► Personnel Hygiene  Clothing  Rest Rooms  Hand Washing  Illness and Lesions

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