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  • 1. Introduction toGMP By V.SARAVANAN
  • 2. What is GMP ?  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. 22/10/2008 Department of Pharmaceutics 2
  • 3. Quality Definition  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 X Quality Safety Efficacy 22/10/2008 Department of Pharmaceutics 3
  • 4. 22/10/2008 Department of Pharmaceutics 4
  • 5. Good Manufacturing Practices  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. 22/10/2008 Department of Pharmaceutics 5
  • 6. Some of the main risks are – unexpected contamination of products, causing damage to health or even death. – incorrect labels on containers, which could mean that patients receive the wrong medicine. – insufficient or too much active ingredient, resulting in ineffective treatment or adverse effects. 22/10/2008 Department of Pharmaceutics 6
  • 7. 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 the intended therapeutic effect. 22/10/2008 Department of Pharmaceutics 7
  • 8. GMP Covers…  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. 22/10/2008 Department of Pharmaceutics 8
  • 9. GMP  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! 22/10/2008 Department of Pharmaceutics 9
  • 10. QA, GMP & QC inter-relationship QA GMP QC 22/10/2008 Department of Pharmaceutics 10
  • 11. QA, GMP & QC inter-relationship QA It is the sum total of the organized arrangements with the objective of ensuring that products will be of the quality required for their intended use 22/10/2008 Department of Pharmaceutics 11
  • 12. QA, GMP & QC inter-relationship GMP Is that part of Quality Assurance aimed at ensuring that products are consistently manufactured to a quality appropriate to their intended use 22/10/2008 Department of Pharmaceutics 12
  • 13. QA, GMP & QC inter-relationship 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 quality 22/10/2008 Department of Pharmaceutics 13
  • 14. QC and QA  QC is that part of GMP  QA is the sum total which is concerned with of organized sampling, arrangements specifications, testing made with the and with in the object of ensuring organization, that product will be documentation,and of the Quality release procedures which ensure that the required by their necessary and relevant intended use. tests are carried out 22/10/2008 Department of Pharmaceutics 14
  • 15. QC and QA  QC is lab based 22/10/2008  QA is company based Department of Pharmaceutics 15
  • 16. GMP guidelines  GMP as per Schedule “M” www.cdsco.nic.in  GMP as per WHO www.who.int  GMP as per MCA now known as MHRA www.mca.gov.uk  GMP as per TGA www.tga.gov.au  GMP as per US FDA www.fda.gov  GMP as per ICH guidelines www.ich.org 22/10/2008 Department of Pharmaceutics 16
  • 17. GMP  Good Manufacturing Practice  Good Management Practice  Get More Profit  Give more Production  GMP Training with out tears 22/10/2008 Department of Pharmaceutics 17
  • 18. Ten Principles of GMP 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. Design and construct the facilities and equipments properly Follow written procedures and Instructions Document work Validate work Monitor facilities and equipment Write step by step operating procedures and work on instructions Design ,develop and demonstrate job competence Protect against contamination Control components and product related processes Conduct planned and periodic audits 22/10/2008 Department of Pharmaceutics 18
  • 19. Beyond GMP  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 22/10/2008 Department of Pharmaceutics 19
  • 20. List of important documents in GMP           Policies SOP Specifications MFR (Master Formula Record) BMR Manuals Master plans/ files Validation protocols Forms and Formats Records 22/10/2008 Department of Pharmaceutics 20
  • 21. 10 attributes of a good document 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. Accurate Clear Complete Consistent Indelible Legible Timely Direct Authentic Authorized 22/10/2008 Department of Pharmaceutics 21
  • 22. Certifying agencies  ICH. www.ich.org  WHO. www.who.int  US FDA. www.fda.gov  EU/EMEA. www.emea.europa.eu 22/10/2008 Department of Pharmaceutics 22
  • 23. cGMP For Finished Pharmaceuticals 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. General Provision Organization & Personnel Building & Facilities Equipment Control of Components & Drug Product Containers & Closures Production & Process Control Packaging & Labeling Control Handling & Distribution Laboratory Control Records & Reports Returned & Salvaged Drugs 22/10/2008 Department of Pharmaceutics 23
  • 24. Control of Components & Drug Product Containers & Closures 1. 2. 3. 4. 5. 6. 7. General requirements. Receipt & storage of untested components, drug product containers, and closures. Testing and approval or rejection of components, drug product containers, and closures. Use of approved components, drug product containers, and closures. Retesting of approved components, drug product containers, and closures. Rejected components, drug product containers, and closures. Drug product containers and closures. 22/10/2008 Department of Pharmaceutics 24
  • 25. Production & Process Control 1. 2. 3. 4. 5. 6. 7. 8. Written procedures; deviations. Charge-in of components. Calculation of yield. Equipment identification. Sampling and testing of in-process materials and drug products. Time limitations on production. Control of microbiological contamination. Reprocessing. 22/10/2008 Department of Pharmaceutics 25
  • 26. Packaging & Labeling Control 1. 2. 3. 4. 5. 6. Materials examination and usage criteria. Labeling issuance. Packaging and labeling operations. Tamper-evident packaging requirements for over-the-counter (OTC) human drug products. Drug product inspection. Expiration dating. 22/10/2008 Department of Pharmaceutics 26
  • 27. Laboratory Control 1. 2. 3. 4. 5. 6. 7. General requirements. Testing and release for distribution. Stability testing. Special testing requirements. Reserve samples. Laboratory animals. Penicillin contamination. 22/10/2008 Department of Pharmaceutics 27
  • 28. Records & Reports 1. 2. 3. 4. 5. 6. 7. 8. 9. General requirements. Equipment cleaning and use log. Component, drug product container, closure, and labeling records. Master production and control records. Batch production and control records. Production record review. Laboratory records. Distribution records. Complaint files. 28
  • 29. THANK YOU 29

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