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Introduction to GMP Training by

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  • 1. Introduction to GMP CHEE 440
  • 2. Objectives Acquire basic knowledge of Good Manufacturing Practices (GMP) What are GMPs ? Why are they important ? CHEE 440
  • 3. History of Food and Drugs Act Government Authorities Canada: Health Canada Health Products and Food Branch (HPFB) USA: Food & Drug Administration (FDA) Europe: EC Directives CHEE 440
  • 4. History Food and Drugs Act Food and Drug Regulations Division 2 : Good Manufacturing Practices 1900’s- Adulterated Food First purity laws enacted 1930’s- Sulfanilimide Drugs had to be proven safe 1960’s- Thalidomide Drugs had to be proven safe and effective through clinical trials CHEE 440
  • 5. Why are GMPs important? Government requirement Ensure quality product Reduce rejects, recalls Satisfied customers Maintain manufacturing consistency Company image and reputation CHEE 440
  • 6. Drugs HPFB Definition: Any substance or mixture of substances manufactured, sold or represented for use in a) the diagnosis, treatment, mitigation or prevention of a disease, a disorder, an abnormal physical state or the symptoms thereof in humans or animals b) restoring, correcting or modifying organic functions in humans or animals c) “disinfection” in premises in which food is manufactured, prepared or kept DIN Label Claim CHEE 440
  • 7. Food and Drugs Act Establishment license Site Reference File HPFB Inspections CHEE 440
  • 8. Production Goals Safety Product is free of unwanted side effects when used appropriately by patient Identity Product exactly matches the labelling and related documents Strength Product has correct concentration, potency or therapeutic activity of active ingredient Purity Product is free from contamination Quality Product meets all standards, expectations; performs as claimed Product made consistently CHEE 440
  • 9. GMP Categories Sale Premises Equipment Personnel Sanitation Raw Material Testing Manufacturing Control CHEE 440 Quality Control Department Packaging Material Testing Finished Product Testing Records Samples Stability Sterile Products Medical Gases
  • 10. Sale C.02.003 No distributor … and no importer shall sell a drug unless it has been fabricated, packaged/labeled, tested, and stored in accordance with the requirements of this Division CHEE 440 1
  • 11. Premises C.02.004 Equipment C.02.005 Permits effective cleaning Prevents contamination Orderly conditions Good state of repair CHEE 440 1
  • 12. Personnel C.02.006 Appropriate education, training and experience Sufficient number of people Receive GMP training Initial and continuing training as relevant to job responsibilities CHEE 440 1
  • 13. Sanitation C.02.007 - .008 Sanitation Program to prevent contamination Limit the sources and types of contamination » Cleaning procedures for facilities & equipment » Pest control » Environmental monitoring Documented evidence CHEE 440 1
  • 14. Sanitation C.02.008 Hygiene Health and eye examinations Report adverse health conditions Clothing requirements » No direct skin contact with product » Wash hands » No jewelry or excessive makeup No smoking, eating, drinking, chewing, or keeping of plants in operations areas CHEE 440 1
  • 15. Raw Material Testing C.02.009 - .010 each lot or batch of raw material is tested three objectives confirm the identity of the raw materials provide assurance that quality of the drug in dosage form will not be altered by raw material defects assure that raw materials have the characteristics that will provide the desired quantity or yield in manufacturing process CHEE 440 1
  • 16. Raw Material, Packaging Material and Finished Product Testing Samples of incoming materials are collected and tested before use Approved test methods and specifications are used Results must conform to specifications for release for use or sale Transportation and storage records CHEE 440 1
  • 17. Manufacturing Control C.02.011 Written procedures are established and followed Master formulae, manufacturing order and packaging order Critical processes are validated 2nd person verification of activities Quarantine system Labelling requirements CHEE 440 1
  • 18. Manufacturing Control C.02.012 Recall Programme Self-Inspection Programme Ensure compliance with vendors/contractors CHEE 440 1
  • 19. Manufacturing Control (cont’d) Validation: the documented act of demonstrating that any procedure, process, equipment, material, activity, or system will consistently lead to the expected results » TPP 1998 Edition Design Qualification (DQ) Installation Qualification (IQ) Operational Qualification (OQ) Performance Qualification (PQ) CHEE 440 1
  • 20. Quality Control Department C.02.013 - C.02.015 Quality Control Responsibilities Testing of bulk components prior to use by production Testing of finished product prior to release for sale Stability program (in association with QA) CHEE 440 2
  • 21. Quality Control Department C.02.013 - C.02.015 Quality Assurance Responsibilities Ensure GMP compliance Review batch records, labels Release product, based on QC test results Authorize all master documents and SOPs Training, auditing Customer complaints Recall CHEE 440 2
  • 22. Key Quality Terms CHANGE CONTROL written procedure that describes the action to be taken if a change is proposed to facilities, etc. used in fabrication, packaging, and testing of drugs or any change that may affect quality or support system operation DEVIATION Planned or unplanned temporary departure from an approved process, specification or procedure with the potential to impact product quality CHEE 440 2
  • 23. Records C.02.020 - C.02.024 Document all GMP activities Use Good Documentation Practices (GDP) Records must be readily available Needed to prove activities were done CHEE 440 2
  • 24. Good Documentation Practices Documentation must be: permanent (black or blue ink) legible, clear, concise accurate timely consistent complete CHEE 440 2
  • 25. Samples and Stability Samples Retain samples of each lot of raw material and finished product for specified period of time Stability Establish the length of time in which the product meets all specifications Monitor the drug for this period of time CHEE 440 2
  • 26. Sterile Products C.02.029 Sterile Products Packaged in separate enclosed area by trained personnel using method to ensure sterility CHEE 440 2
  • 27. Summary Pharmaceutical Industry is regulated by GMPs Good Manufacturing Practices must be followed GMPs ensure drug products are safe, pure and effective. CHEE 440 2