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Introduction to GMP

Introduction to GMP. Objectives. Acquire basic knowledge of Good Manufacturing Practices (GMP) What are GMPs ? Why are they important ?. History of Food and Drugs Act. Government Authorities Canada: Health Canada Health Products and Food Branch (HPFB)

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Introduction to GMP

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  1. Introduction to GMP

  2. Objectives • Acquire basic knowledge of Good Manufacturing Practices (GMP) • What are GMPs ? • Why are they important ?

  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

  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

  5. Why are GMPs important? • Government requirement • Ensure quality product • Reduce rejects, recalls • Satisfied customers • Maintain manufacturing consistency • Company image and reputation

  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

  7. Food and Drugs Act • Establishment license • Site Reference File • HPFB Inspections

  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

  9. Sale Premises Equipment Personnel Sanitation Raw Material Testing Manufacturing Control Quality Control Department Packaging Material Testing Finished Product Testing Records Samples Stability Sterile Products Medical Gases GMP Categories

  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

  11. Premises C.02.004Equipment C.02.005 • Permits effective cleaning • Prevents contamination • Orderly conditions • Good state of repair

  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

  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

  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

  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

  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

  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

  18. Manufacturing Control C.02.012 • Recall Programme • Self-Inspection Programme • Ensure compliance with vendors/contractors

  19. 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) Manufacturing Control (cont’d)

  20. Quality Control DepartmentC.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)

  21. Quality Control DepartmentC.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

  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

  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

  24. Good Documentation Practices • Documentation must be: • permanent (black or blue ink) • legible, clear, concise • accurate • timely • consistent • complete

  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 theproduct meets all specifications • Monitor the drug for this period of time

  26. Sterile Products C.02.029 • Sterile Products • Packaged in separate enclosed area by trained personnel using method to ensure sterility

  27. Summary • Pharmaceutical Industry is regulated by GMPs • Good Manufacturing Practices must be followed • GMPs ensure drug products are safe, pure and effective.

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