GMP in Production of Animal Vaccine

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Requirements for production of animal vaccines.

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  • We looking to set up plant of veterinary vaccines in Egypt, our party has decided to do this. So I required your slide presentation. Please send me on Bhavna_shelar@rediffmail.com
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  • Very interesting hi spresentation, you can shared with me. Thanks in advance.
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  • Sir, I found this presentation is very useful for my understanding on the GMP requirement on veterinary vaccine. Could you please help to share this presentation with me? This presentation will not be used for commercial purpose. My email address is 13818065616@163.com
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  • Sir I am working in a vaccine production unit in south india. Please let me view and down load your presentation. It will not be used for commercial purpose My e mail address is vetroy@gmail.com
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GMP in Production of Animal Vaccine

  1. 1. GMP inProduction ofAnimal VaccineBalraj Singh ThapaQuality Assurance
  2. 2. Agenda  Introduction  Historyof GMP  Why GMP is important  GMP Coverage  Ten Golden Rules of GMP  cGMP for Animal Vaccine  Challenges with Vaccine  Dilemma faced by Industry  Summary  GMP Guidelines across the GlobeMar 2, 2013 GMP in Production of Animal Vaccine 2
  3. 3. Introduction  Good Manufacturing Practice is a set of regulations, codes, and guidelines for the manufacture of drug substances and drug products, medical devices, in vivo and in vitro diagnostic products, and foods.Mar 2, 2013 GMP in Production of Animal Vaccine 3
  4. 4. Introduction A basic tenet of GMP is that quality cannot be tested into a batch of product but must be built into each batch of product during all stages of the manufacturing process.  Hence Good Manufacturing Practices are control measures used to ensure the quality, safety, purity, and efficacy of products.Mar 2, 2013 GMP in Production of Animal Vaccine 4
  5. 5. History of GMP  1902 - Development of the Biologic Control Act  1906 - Development of the Pure Food and Drug Act  1938 - Federal Food, Drug and Cosmetic Act  1941 - Initiation of GMP  1944 - Development of Public Health Services Act  1962 - Kefauver-Harris Drug Amendments released  1963 - Establishment of GMPs for Drugs  1975 - cGMPs for Blood and Components Final Rule  1976 - Medical Device Amendments  1978 - cGMPs for Drugs and Devices  1979 - GLPs Final Rule  1980 - Infant Formula Act is passedMar 2, 2013 GMP in Production of Animal Vaccine 5
  6. 6. History of GMP 1941 Initiation of GMP  December 1940, Winthrop Chemical Company’s Sulfathiaziole tablets contaminated with phenobarbital  1941 - 300 people died/injured  FDA enforced and revised manufacturing and quality control requirements  1941 - GMP is bornMar 2, 2013 GMP in Production of Animal Vaccine 6
  7. 7. History of GMP 1962 Kefauver-Harris Drug Amendments  Thalidomide tragedy  Thousands of children born with birth defects due to adverse drug reactions of morning sickness pill taken by mothers  Strengthen FDA’s regulations regarding experimentation on humans and proposed new way how drugs are approved and regulated.Mar 2, 2013 GMP in Production of Animal Vaccine 7
  8. 8. Why GMP is Important A poor quality medicine may contain toxic substances that have been unintentionally added A medicine that contains little or none of the claimed ingredient will not have intended therapeutic effect.  Most countries will only accept import of medicines that have been manufactured to internationally recognized GMP standards.Mar 2, 2013 GMP in Production of Animal Vaccine 8
  9. 9. GMP Coverage  All aspects of production; from the starting materials, premises and equipment to the training and personal hygiene of staff.  Detailed, written procedures are essential for each process that could affect the quality of the finished product.  Systems to provide documented proof that correct procedures are consistently followed at each step in the manufacturing process – every time a product is made.Mar 2, 2013 GMP in Production of Animal Vaccine 9
  10. 10. Ten Golden Rules of GMP 1. Be fit for the job 2. Stay fit for the job 3. Have plant & machinery fit for intended use 4. Maintain the plant & machinery always fit for intended use 5. Have a stable, capable processMar 2, 2013 GMP in Production of Animal Vaccine 10
  11. 11. Ten Golden Rules of GMP 6. Validate the process 7. Have written operating procedures for the work 8. Follow the written operating procedures in the work 9. Cross check and report the data as you do it 10. Audit for continued conformance.Mar 2, 2013 GMP in Production of Animal Vaccine 11
  12. 12. cGMP for Animal Vaccine 1. Organization & Personnel. 2. Building & Facilities. 3. Equipments. 4. Control of Components. 5. Production & Process Control. 6. Packaging & Labelling Control. 7. Laboratory Controls. 8. Handling & Distribution 9. Records & Reports 10. Return & Salvaged Drugs.Mar 2, 2013 GMP in Production of Animal Vaccine 12
  13. 13. Organization & Personnel  Management Involvement & Responsibility  Policies & Procedures  Quality Manual  Personnel Qualifications  Job description.  Trainings on cGMP.Mar 2, 2013 GMP in Production of Animal Vaccine 13
  14. 14. Building & Facilities  FDA Approved layouts & design.  Classified Rooms – HVAC – HEPA filters – Bio-containment – Access Controlled  Plumbing & Lighting  Sewage & Refuse – Kill Tanks – Bio-waste, IncineratorMar 2, 2013 GMP in Production of Animal Vaccine 14
  15. 15. Building & Facilities CLEAN ROOM CORRIDORMar 2, 2013 GMP in Production of Animal Vaccine 15
  16. 16. Equipments  Equipments design, size and location.  Equipment construction. – SS 316 L  Equipment cleaning. – CIP/SIP  Auto controlled Fermentors.  Ultra-filtration Units.  LAF Units, Bio-safety Cabinets.  Validated & Calibrated.Mar 2, 2013 GMP in Production of Animal Vaccine 16
  17. 17. Equipments CELL FERMENTOR OPERATIONSMar 2, 2013 GMP in Production of Animal Vaccine 17
  18. 18. Control of Components  Raw Material, Containers and Closures – Receipt and storage – Testing and approval or rejection – Retesting  Seed (Virus / bacteria, Cells) – Source – National / International – Passage level – QC – Purity, Sterility, Extraneous agents – Storage in -70°C Deep Freeze, Liquid NitrogenMar 2, 2013 GMP in Production of Animal Vaccine 18
  19. 19. Control of Components ISSUANCE OF RAW MATERIAL CELLS FROM LN2 CONTAINERMar 2, 2013 GMP in Production of Animal Vaccine 19
  20. 20. Production & Process Control  Standard Operating Procedures (SOP).  Process Validation  Batch Manufacturing Record (BMR)  Identification of each stage.  In-process Quality Control (IPQC).  Aseptic Processing – Cleaning – Fumigation – Clean Rooms / Closed operationMar 2, 2013 GMP in Production of Animal Vaccine 20
  21. 21. Packaging & Labelling Control  Materials examination and release criteria – Master with QC – Specifications  Controlled Issuance (Kept in lockers)  Packaging and labelling operations – Monitored  Over printing details approved – Batch Number – Expiry DateMar 2, 2013 GMP in Production of Animal Vaccine 21
  22. 22. Laboratory Controls  Testing equipments & facility. – Analytical Laboratory – Microbiological Laboratory – Biological Testing Laboratory  Pharmacopeia, Test procedures.  Control sample, Stability Chambers  Animal Testing – Small Animal House – Large Animal House – Challenge FacilityMar 2, 2013 GMP in Production of Animal Vaccine 22
  23. 23. Handling & Distribution  Warehouse & Storage – Cold Room – Deep Freeze (-20° / -70° C) – Liquid Nitrogen  Distribution procedures – Cold Chain – Cold Van – AirMar 2, 2013 GMP in Production of Animal Vaccine 23
  24. 24. Records & Reports  Equipment cleaning and use log  Master formula and control records (MFR)  Batch manufacturing record (BMR)  Laboratory Testing Records  Animal Testing Records  Certificate of Analysis  Distribution Records  Cold Chain Monitoring Records  Complaint files  Audit ReportsMar 2, 2013 GMP in Production of Animal Vaccine 24
  25. 25. Return & Salvaged Drugs  Returned products – Kept under Quarantine in bonded room  Retested – Complete testing for efficacy  Approved or rejectedMar 2, 2013 GMP in Production of Animal Vaccine 25
  26. 26. Unique challenges with Vaccines  Unlike a substantial number of injectables pharmaceuticals, vaccines are administered to a large population of patients that are most often young and healthy.  Starting materials may have inherent bioburden, e.g. egg-based vaccines or may be infectious until inactivated e.g. bacterial vaccines.  From beginning to end, the manufacturing process for a vaccine can take several months to a year.Mar 2, 2013 GMP in Production of Animal Vaccine 26
  27. 27. Unique challenges with Vaccines  Must be processed under defined conditions/controls throughout production to consistently produce a safe, pure and potent product and preclude the introduction of environmental contamination.  Cannot withstand heat sterilization without affecting product quality, hence must be processed ‘aseptically’.Mar 2, 2013 GMP in Production of Animal Vaccine 27
  28. 28. Unique challenges with Vaccines  Bioburden testing of the product at various points in the manufacturing process.  Segregation of pre- and post-inactivation steps and appropriate methods for inactivation testing.  Cleaning of facilities and equipment using procedures shown to be effective for removal of residual product and bioburden.  Monitoring of the manufacturing environment to continuously assess conditions.Mar 2, 2013 GMP in Production of Animal Vaccine 28
  29. 29. Unique challenges with Vaccines  Product is filter sterilized at some point during the manufacturing process.  For vaccines, this may be earlier in the process than many products. – Once conjugated to an adjuvant, sterile filtration no longer possible  Subsequent steps must be carefully controlled to avoid introduction of contaminants.  Careful adherence to aseptic technique /practice by personnel is must.Mar 2, 2013 GMP in Production of Animal Vaccine 29
  30. 30. Dilemma faced by Industry  Defined conditions / controls not in place throughout the manufacturing process, has resulted in failures at the end of production. – Automation  Issues with inactivation steps. – Adverse affect of Inactivating agent - Alternate  Inadequate cleaning procedures that result in cross-contamination. Robust CIP / SIPMar 2, 2013 GMP in Production of Animal Vaccine 30
  31. 31. Dilemma faced by Industry  Environmental monitoring data collected but not adequately evaluated or investigated when levels exceeded or same organisms identified in the in-process or final product.  Inadequacies in aseptic processing: – Validation doesn’t simulate actual manufacturing conditions – Poor aseptic technique observed during aseptic operations PERSONNEL TRAININGMar 2, 2013 GMP in Production of Animal Vaccine 31
  32. 32. Summary  GMP is a guideline  GMP is a control measure  GMP is to be read and learned  GMP is to be practiced & implemented  GMP is constantly evolving - currentGMPMar 2, 2013 GMP in Production of Animal Vaccine 32
  33. 33. GMP Guidelines - Global  GMP as per Schedule “M” – Drugs & Cosmetics Act, 1940 www.cdsco.nic.in  GMP as per WHO – Over 100 countries www.who.int  GMP as per MHRA (Medicines and Healthcare Products Regulatory Agency) www.mca.gov.uk  GMP as per TGA (Therapeutically Goods Administration) www.tga.gov.au  GMP as per US FDA (Food & Drug Administration) www.fda.gov  GMP as per ICH guidelines (International Conference of Harmonization) www.ich.orgMar 2, 2013 GMP in Production of Animal Vaccine 33
  34. 34. Questions ? Balraj S Thapa Email : rajthapa2006@gmail.comMar 2, 2013 GMP in Production of Animal Vaccine 34

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