Gmp cgmp qa considerations- by Mr. Kailash Vilegave


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Gmp cgmp qa considerations- by Mr. Kailash Vilegave

  1. 1. Mr. Kailash Vilegave M Pharma Lecturer, Dept of PharmaceuticsShivajirao S. jondhle College of Pharmacy Asangaon
  2. 2.  Globalization has been the key word in restructuring of the Indian economy which calls for integration of Indian trade and business with world market. However, to tap opportunities in the potential world market it is imperative that the manufacturing sector tries to reach the international level in terms of quality, cost, safety, and reliability. To authenticate organizational standards it would required accreditation from international certification bodies. The international organization for standardization (ISO) is one such certification level under ISO 9000. These standers are widely accepted by the lately unified market of the European Economic Community (EEC) Department of Pharmaceutics 2
  3. 3.  Certifacationis the mechanism by which a costimer can have confidance in a compony and is most effective when carried out by a national certification body. In increasing number of market and third party quality assesment and certifiacation is becoming a prerequisite for doing buisness. Thus if the compony operates a quality system complying with the standards allows the purchaser to have increased confidence in the quality of the product concerned and the service associated with the suppy of the product Department of Pharmaceutics 3
  4. 4.  FDA & industry are in agreement that the consumer must receive safe, effective, and quality product. Preformulation studies to judge the quality of raw material. Schedule M – Drug and Cosmetic act 1945 describes law as “ Good Manufacturing Practices & requirements of premises, plant and equipment.” Rule 71 of Drug and Cosmetic act 1945 clearly specifies the condition for grant or renewal of license in form 25 (25F) Department of Pharmaceutics 4
  5. 5.  GMP is that part of Quality assurance which ensures that the products are consistently manufactured and controlled to the Quality standards appropriate to their intended use "GMP" - A set of principles and procedures which, when followed by manufacturers for therapeutic goods, helps ensure that the products manufactured will have the required quality. "GMP“ – provides specific gudelines to serve to checks for criticle operation within the organisation so that a total quality controll system can be achieved Department of Pharmaceutics 5
  6. 6. T QM Zero deffect product Withstand in global market Safty & efficacy in the entire organization. Efficient operation during work process. Department of Pharmaceutics 6
  7. 7.  20-25 % increase productivity 40-50%reduction in work in process due to more efficient & swifter technique. Decrease manufacturing cost Avoidance of accident within entire organization. Personnel hygiene and health is achieved. Department of Pharmaceutics 7
  8. 8.  Usually see “cGMP” – where c = current, to emphasize that the expectations are dynamic In this some aditional guidelines for Manufacturing, Packaging, Storage & installation of medicle servises into organisation.C GMP may also be viewed as consisting of the following four essential elements. 4 „ P ‟s –  1.Personnels  2.Parts  3.Process  4.Procedures Department of Pharmaceutics 8
  9. 9. 4 „ P ‟s essential Element to represent CGMP1.Personnels: The people system and manpower required to carryout the various tasks within the manufacturing and control function.2. Parts: The raw material and components used in connection with the manufacture and packaging of the drug product as well as the material used in association with the control.3. Process: The building, facilities, equipments instrumentation and support systems (heat, air, vacuum, water, & lighting ) used in connection with the manufacturing process and the control.4. procedure: the paper work, documentation of records used in connection with the manufacturing process and its control Department of Pharmaceutics 9
  10. 10.  Quality of a medicinal product is measured by it‟s fitness for purpose . Safety and efficacy are not separable from Quality but part of it Quality = Safety + Efficacy + Purity Department of Pharmaceutics 10
  11. 11. Department of Pharmaceutics 11
  12. 12. 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. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product. Department of Pharmaceutics 12
  13. 13.  unexpectedcontamination of products, causing damage to health or even death. incorrectlabels on containers, which could mean that patients receive the wrong medicine. insufficientor too much active ingredient, resulting in ineffective treatment or adverse effects. Department of Pharmaceutics 13
  14. 14.  Mostcountries will only accept import and sale of medicines that have been manufactured to internationally recognized GMP. Governments seeking to promote their countries export of pharmaceuticals can do so by making GMP mandatory for all pharmaceutical production and by training their inspectors in GMP requirements. Department of Pharmaceutics 14
  15. 15.  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. There must be systems to provide documented proof that correct procedures are consistently followed at each step in the manufacturing process - every time a product is made. Department of Pharmaceutics 15
  16. 16.  The Quality of a formulation or a bulk drug depends on the Quality of those producing it GMP is the magic key that opens the door of the Quality In matter of GMP, swim with the current and in matter of Quality stand like a rock! Department of Pharmaceutics 16
  17. 17. QA GMP QCDepartment of Pharmaceutics 17
  18. 18. QAIt is the sum total of the organizedarrangements with the objective of ensuring that products will be of the quality required for their intended useDepartment of Pharmaceutics 18
  19. 19. GMP Is that part of Quality Assurance aimed at ensuring that products are consistently manufactured to a quality appropriate to their intended useDepartment of Pharmaceutics 19
  20. 20. QC Is that part of GMP concerned with sampling, specification & testing, documentation & release procedures which ensure that the necessary & relevant tests are performed & the product is released for use only after ascertaining it’s qualityDepartment of Pharmaceutics 20
  21. 21.  QC is that part of GMP which  QA is the sum total of is concerned with sampling, organized arrangements specifications, testing and with made with the object of in the organization, ensuring that product documentation,and release will be of the Quality procedures which ensure that required by their the necessary and relevant intended use. tests are carried out Department of Pharmaceutics 21
  22. 22.  Operational  Allthose planned or laboratory systematic actions techniques and necessary to provide activities used to adequate confidence fulfill the that a product will requirement of satisfy the Quality requirements for quality Department of Pharmaceutics 22
  23. 23.  QC is lab based  QA is company based Department of Pharmaceutics 23
  24. 24.  GMP as per Schedule “M” GMP as per WHO GMP as per MCA now known as MHRA GMP as per TGA GMP as per US FDA GMP as per ICH guidelines Department of Pharmaceutics 24
  25. 25.  GMP in solid dosage forms GMP in semisolid dosage forms GMP in Liquid orals GMP in Parenterals Production GMP in Ayurvedic medicines GMP in Bio technological products GMP in Nutraceuticals and cosmeceuticals GMP in Homeopathic medicines Department of Pharmaceutics 25
  26. 26.  Good Manufacturing Practice Good Management Practice Get More Profit Give more Production GMP Training with out tears Department of Pharmaceutics 26
  27. 27.  Allpast GMPs are history….It is looking like in rear view mirror and driving Department of Pharmaceutics 27
  28. 28. 1. Design and construct the facilities and equipments properly2. Follow written procedures and Instructions3. Document work4. Validate work5. Monitor facilities and equipment6. Write step by step operating procedures and work on instructions7. Design ,develop and demonstrate job competence8. Protect against contamination9. Control components and product related processes10. Conduct planned and periodic audits Department of Pharmaceutics 28
  29. 29.  Reduce pollution - Zero discharge Adaptation of environment friendly methods Consideration for better and healthier life tomorrow Consideration of ethics in life One should begin with end in mind otherwise it will be the beginning of the end Department of Pharmaceutics 29
  30. 30.  In fact Cost benefits – positive cost benefits of GMP/QA Good plant lay out, Smooth work flows, Efficient documentation systems, well controlled process, good stores lay outs and stores records- These are Good manufacturing practices Reduction in work in process and inventory holding costs Avoidance of cost of Quality failure ( cost of waste, of rework, of recall, of consumer compensation and of loss of company reputation) Department of Pharmaceutics 30
  31. 31.  Policies SOP Specifications MFR (Master Formula Record) BMR Manuals Master plans/ files Validation protocols Forms and Formats Records Department of Pharmaceutics 31
  32. 32. 1. Accurate2. Clear3. Complete4. Consistent5. Indelible6. Legible7. Timely8. Direct9. Authentic10. Authorized Department of Pharmaceutics 32
  33. 33.  ICH. WHO. US FDA. EU/EMEA. Department of Pharmaceutics 33
  34. 34. At a high level, GMPs of various nations are verysimilar; most require things like: Equipment and facilities being properly designed, maintained, and cleaned Standard Operating Procedures (SOPs) be written and approved An independent Quality unit (like Quality Control and/or Quality Assurance) Well trained personnel and management Department of Pharmaceutics 34
  35. 35. 1. General Provision2. Organization & Personnel3. Building & Facilities4. Equipment5. Control of Components & Drug Product Containers & Closures6. Production & Process Control7. Packaging & Labeling Control8. Handling & Distribution9. Laboratory Control10. Records & Reports11. Returned & Salvaged Drugs Department of Pharmaceutics 35
  36. 36. 1. Responsibilities of quality control unit.2. Personnel qualifications.3. Personnel responsibilities.4. Consultants. Department of Pharmaceutics 36
  37. 37. 1. Design and construction features.2. Lighting.3. Ventilation, air filtration, air heating and cooling.4. Plumbing.5. Sewage and refuse.6. Washing and toilet facilities.7. Sanitation.8. Maintenance. Department of Pharmaceutics 37
  38. 38. 1. Equipment design, size, and location.2. Equipment construction.3. Equipment cleaning and maintenance.4. Automatic, mechanical, and electronic equipment.5. Filters. Department of Pharmaceutics 38
  39. 39. 1. General requirements.2. Receipt & storage of untested components, drug product containers, and closures.3. Testing and approval or rejection of components, drug product containers, and closures.4. Use of approved components, drug product containers, and closures.5. Retesting of approved components, drug product containers, and closures.6. Rejected components, drug product containers, and closures.7. Drug product containers and closures. Department of Pharmaceutics 39
  40. 40. 1. Written procedures; deviations.2. Charge-in of components.3. Calculation of yield.4. Equipment identification.5. Sampling and testing of in-process materials and drug products.6. Time limitations on production.7. Control of microbiological contamination.8. Reprocessing. Department of Pharmaceutics 40
  41. 41. 1. Materials examination and usage criteria.2. Labeling issuance.3. Packaging and labeling operations.4. Tamper-evident packaging requirements for over-the-counter (OTC) human drug products.5. Drug product inspection.6. Expiration dating. Department of Pharmaceutics 41
  42. 42. 1. Warehousing procedures.2. Distribution procedures. Department of Pharmaceutics 42
  43. 43. 1. General requirements.2. Testing and release for distribution.3. Stability testing.4. Special testing requirements.5. Reserve samples.6. Laboratory animals.7. Penicillin contamination. Department of Pharmaceutics 43
  44. 44. 1. General requirements.2. Equipment cleaning and use log.3. Component, drug product container, closure, and labeling records.4. Master production and control records.5. Batch production and control records.6. Production record review.7. Laboratory records.8. Distribution records.9. Complaint files. Department of Pharmaceutics 44
  45. 45. 1. Returned drug products.2. Drug product salvaging. 45 Department of Pharmaceutics
  46. 46. Department of Pharmaceutics 46