Materials gmp


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Materials gmp

  1. 1. Materials/Standards Supaporn Phumiamorn Division of Biological Products GMP course, 17-18 Jan, 2006
  2. 2. Type of materials <ul><li>Starting materials </li></ul><ul><li>Packaging materials </li></ul><ul><li>Intermediate and bulk materials </li></ul><ul><li>Finished products </li></ul><ul><li>Rejected and recovered materials </li></ul><ul><li>Returned goods </li></ul><ul><li>Recalled products </li></ul>
  3. 3. <ul><li>Reagent and culture media </li></ul><ul><li>Reference standards </li></ul><ul><li>Waste materials </li></ul><ul><li>Miscellaneous materials </li></ul>
  4. 4. General requirements for materials <ul><li>All incoming materials and finished products </li></ul><ul><li>- quarantined after receipt </li></ul><ul><li>- until release for use </li></ul><ul><li>- distribution </li></ul>
  5. 5. <ul><li>Stored </li></ul><ul><li>- under appropriate condition </li></ul><ul><li>-orderly fashion (batch segregation) </li></ul><ul><li>- materials management </li></ul><ul><li>-stock rotation (FIFO, FEFO) </li></ul>General requirements for materials
  6. 6. <ul><li>Documentation </li></ul><ul><li>- SOPs </li></ul><ul><li>- Records </li></ul><ul><li>- Labels </li></ul><ul><li>- Specifications </li></ul>General requirements for materials
  7. 7. Starting materials <ul><li>Purchasing </li></ul><ul><li>Suppliers </li></ul><ul><li>Consignment </li></ul><ul><li>- integrity - delivery note </li></ul><ul><li>- seal - supplier’s label </li></ul><ul><li>- order </li></ul><ul><li>Cleaned and labeled </li></ul>
  8. 8. <ul><li>Damaged containers </li></ul><ul><li>Starting materials label: </li></ul><ul><li>- name and internal code </li></ul><ul><li>- batch number </li></ul><ul><li>- status </li></ul><ul><li>- expiry date or re-test date </li></ul><ul><li>Sample container identified </li></ul>Starting materials
  9. 9. <ul><li>Use only released material </li></ul><ul><li>Dispensing </li></ul><ul><li>- designated persons </li></ul><ul><li>- written procedure </li></ul><ul><li>- accurately weighed </li></ul><ul><li>- clean, labeled containers </li></ul>Starting materials
  10. 10. <ul><li>Independent checks </li></ul><ul><li>- material and weight </li></ul><ul><li>Dispensed material </li></ul><ul><li>- kept together and labeled </li></ul>Starting materials
  11. 11. Why starting materials are so important? <ul><li>Because their quality can directly </li></ul><ul><li>affect the quality of finished </li></ul><ul><li>products </li></ul>
  12. 12. Packaging materials <ul><li>Primary and printed materials: </li></ul><ul><li>- as for starting materials </li></ul><ul><li>purchasing, handing and control </li></ul><ul><li>No unauthorized access </li></ul><ul><li>Storage and transport </li></ul><ul><li>- avoid mix-ups </li></ul><ul><li>- issue and return: SOP </li></ul>
  13. 13. Intermediate and bulk products <ul><li>Appropriate conditions </li></ul><ul><li>Purchased: </li></ul><ul><li>-as starting materials </li></ul>
  14. 14. Finished products <ul><li>Quarantine until released </li></ul><ul><li>Storage conditions </li></ul><ul><li>Evaluation and documentation </li></ul><ul><li>- product release </li></ul>
  15. 15. Rejected and recovered materials <ul><li>Rejected materials </li></ul><ul><li>- clearly marked </li></ul><ul><li>- stored separately in restricted areas </li></ul><ul><li>- take action rapidly </li></ul>
  16. 16. <ul><li>Reprocessing </li></ul><ul><li>- exceptional </li></ul><ul><li>- procedure and records </li></ul><ul><li>- batch number </li></ul><ul><li>- additional testing </li></ul>
  17. 17. <ul><li>Recovery </li></ul><ul><li>- prior authorization </li></ul><ul><li>- additional testing </li></ul>
  18. 18. Recalled products and returned goods <ul><li>Recalled products </li></ul><ul><li>- identified </li></ul><ul><li>-stored separately </li></ul><ul><li>- access controlled </li></ul>
  19. 19. <ul><li>Returned goods </li></ul><ul><li>- SOP: decision regarding the fate </li></ul><ul><li>- nature of product, storage conditions </li></ul><ul><li>- history, time lapse </li></ul><ul><li>- records </li></ul>
  20. 20. Reagents and culture media <ul><li>Record upon receipt or preparation </li></ul><ul><li>Reagents: </li></ul><ul><li>- preparation in accordance with SOP </li></ul><ul><li>- label: </li></ul><ul><li>- concentration, shelf-life, storage conditions </li></ul><ul><li>- signed and dated </li></ul>
  21. 21. <ul><li>Culture media: </li></ul><ul><li>- positive and negative controls </li></ul>
  22. 22. <ul><li>Standard must be stable </li></ul><ul><li>Sufficient standard must be available for several years </li></ul>Reference Standard
  23. 23. <ul><li>Secondary or working standards: </li></ul><ul><li>- appropriate checks and tests </li></ul><ul><li>- regular intervals </li></ul><ul><li>- based on official reference standards </li></ul>
  24. 24. WHO Expert Committee on Biological Standardization (ECBS) <ul><li>One of the oldest WHO committees </li></ul><ul><li>Began as a mechanism for developing primary biological standards </li></ul><ul><li>Meet each year in Geneva </li></ul><ul><li>Members chosen from the Expert Advisory Panel </li></ul><ul><li>Reports published in WHO Technical Report Series </li></ul>
  25. 25. <ul><li>Purpose </li></ul><ul><li>- To establish primary biological standards </li></ul><ul><li>- To prepare written guidance on production and quality control of biological medicinal products </li></ul><ul><li>- To develop international consensus on issues of quality, safety and efficacy related to biological products </li></ul>WHO Expert Committee on Biological Standardization (ECBS)
  26. 26. Biological reference materials <ul><li>Standard and test must be similar in composition and behave in the same way in the test system </li></ul><ul><li>Standard does not have to be pure </li></ul><ul><li>Standard must have potency value assigned </li></ul>
  27. 27. Calibration System WHO: Calibration is generally achieved by parallel titration on at least six separate occasions. NCL: Calibration is routinely performed at least six times by at least two persons. (2 NCL labs + Manufacturer lab)
  28. 28. Calibration of WRP for Total OPV (Measles, Mumps, Rubella)
  29. 29. Parallel line assay Response Dose Parallelity Linearity 95% confidence limit Probit analysis (JE, Rabies ,Hepatitis B, Pertussis vaccines)
  30. 30. Reference Standard materials assuring the uniformity of the testing results assuring the reliability of the testing results
  31. 31. Waste materials and miscellaneous materials <ul><li>Waste materials </li></ul><ul><li>- proper and safe storage </li></ul><ul><li>- toxic and flammable materials </li></ul><ul><li>- separate, enclosed, as per legislation </li></ul><ul><li>- not allowed to accumulate </li></ul><ul><li>- collected for safe disposal </li></ul><ul><li>- regular intervals </li></ul>
  32. 32. <ul><li>Miscellaneous </li></ul><ul><li>- rodenticides, insecticides, sanitizing materials </li></ul><ul><li>- contamination risks </li></ul>
  33. 33. Materials checklist <ul><li>Quarantine </li></ul><ul><li>Storage condition </li></ul><ul><li>Purchasing </li></ul><ul><li>Labelling </li></ul><ul><li>Use of release material </li></ul><ul><li>Printed packaging material </li></ul><ul><li>Purchasing of intermediate or bulk </li></ul>
  34. 34. Materials checklist Records of the original and history of seeds/ banks and etc. <ul><li>Specifications for biological additives </li></ul><ul><li>Trypsin is mycoplasma free </li></ul><ul><li>Fetal calf serum if from BSC free animals </li></ul>Certificate of analysis from the supplier Records of audit of supplier
  35. 35. Warehouse area <ul><li>Entering </li></ul><ul><li>Sufficient capacity </li></ul><ul><li>Good storage conditions </li></ul><ul><li>Sanitation program </li></ul><ul><li>Receiving and dispatch bays </li></ul><ul><li>Quarantine areas </li></ul><ul><li>Sampling areas </li></ul><ul><li>Segregation </li></ul>
  36. 36. <ul><li>Highly active and hazardous materials </li></ul><ul><li>Handling and distribution </li></ul><ul><li>Contanmination and cross-contamination </li></ul><ul><li>The First Expired/First Out (FEEO) </li></ul><ul><li>Rejected materials </li></ul><ul><li>Narcotic </li></ul><ul><li>Damaged items </li></ul>Warehouse area
  37. 37. Warehousing and Distribution <ul><li>Products </li></ul>Quarantine Quality control Release - FIFO - FEFO
  38. 38. Storage conditions <ul><li>Stability </li></ul><ul><li>Monitoring </li></ul><ul><li>- Check and record </li></ul><ul><li>- Records </li></ul><ul><li>- Equipment calibration </li></ul>
  39. 39. Documentations and records <ul><li>SOPs and Records </li></ul><ul><li>Written information </li></ul><ul><li>Container’s label </li></ul><ul><li>- Name </li></ul><ul><li>- Lot number </li></ul><ul><li>- Shelf life </li></ul><ul><li>- Storage conditions </li></ul>
  40. 40. Receipt of incoming materials <ul><li>Check against the relevant purchase order </li></ul><ul><li>Uniformity </li></ul><ul><li>Container inspection </li></ul><ul><li>Record should be retained for each delivery </li></ul><ul><li>Sampling </li></ul><ul><li>Quarantine and batch segregation </li></ul><ul><li>Written release or rejection </li></ul><ul><li>Rejected materials cannot be used </li></ul>
  41. 41. Stock rotation and control <ul><li>Comprehensive records </li></ul><ul><li>Periodic stock reconciliation </li></ul><ul><li>Significant stock discrepancies </li></ul><ul><li>Re-close and reseal </li></ul><ul><li>Damaged containers </li></ul><ul><li>Outdate materials </li></ul>
  42. 42. Dispatch and transport <ul><li>Integrity </li></ul><ul><li>Special care for dry ice </li></ul><ul><li>Delivery order </li></ul><ul><li>Rules for dispatch </li></ul><ul><li>The outside container </li></ul><ul><li>Monitor conditions during transportation </li></ul>
  43. 43. Warehouse check list Identification of all customers Records of storage: time, temperatures Records of date, quantity, mode of packaging Distribution to customer SOPs for storage of released products
  44. 44. SOPs for warehousing SOPs for shipping, final transit conditions and storage Validation and monitoring of shipping methods Recalled Maintenance of records for 2 years beyond Expiry date
  45. 45. References <ul><li>WHO,1997. Joint training on GMP for biological products in Thailand, 2-11 September, 1997 </li></ul><ul><li>Chung Keel Lee, 2003. GMP and related topics, 13-15 October, 2003. </li></ul><ul><li>Chung Keel Lee, 2004. Current GMP for biological products and its practical implementation, 22-23 March, 2004. </li></ul><ul><li>FDA and WHO, 2004. GMP inspection workshop, 21-29 June, 2004. </li></ul>