GMP 2- 2013.ppt notes on gooda mmpractic
- 1. GMP
- 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. Feb 2018 SKP 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 Feb 2018 SKP 3
- 4. Feb 2018 SKP 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. Feb 2018 SKP 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. Feb 2018 SKP 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. Feb 2018 SKP 7
- 8. GMP helps boost pharmaceutical export opportunities •Most countries 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. Feb 2018 SKP 8
- 9. 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. Feb 2018 SKP 9
- 10. 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 Feb 2018 SKP 10
- 11. QA, GMP & QC inter-relationship Feb 2018 SKP 11 QC GMP QA
- 12. QA, GMP & QC inter-relationship 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 Feb 2018 SKP 12 QA
- 13. QA, GMP & QC inter-relationship Is that part of Quality Assurance aimed at ensuring that products are consistently manufactured to a quality appropriate to their intended use Feb 2018 SKP 13 GMP
- 14. QA, GMP & QC inter-relationship 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 Feb 2018 SKP 14 QC
- 15. QC and QA • QC is that part of GMP which is concerned with sampling,specifications, testing and with in the organization, documentation, and release procedures which ensure that the necessary and relevant tests are carried out। • QA is the sum total of organized arrangements made with the object of ensuring that product will be of the Quality required by their intended use. Feb 2018 SKP 15
- 16. QC and QA • Operational laboratory techniques and activities used to fulfill the requirement of Quality • All those planned or systematic actions necessary to provide adequate confidence that a product will satisfy the requirements for quality Feb 2018 SKP 16
- 17. QC and QA • QC is lab based • QA is company based Feb 2018 SKP 17
- 18. 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 Feb 2018 SKP 18
- 19. GMP •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 Feb 2018 SKP 19
- 20. GMP • Good Manufacturing Practice • Good Management Practice • Get More Profit • Give more Production • GMP Training with out tears Feb 2018 SKP 20
- 21. GMP • All past GMPs are history….It is looking like in rear view mirror and driving Feb 2018 SKP 21
- 22. Ten Principles of GMP 1. Design and construct the facilities and equipments properly 2. Follow written procedures and Instructions 3. Document work 4. Validate work 5. Monitor facilities and equipment 6. Write step by step operating procedures and work on instructions 7. Design ,develop and demonstrate job competence 8. Protect against contamination 9. Control components and product related processes 10. Conduct planned and periodic audits Feb 2018 SKP 22
- 23. 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 Feb 2018 SKP 23
- 24. Cost of effective GMP •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) Feb 2018 SKP 24
- 25. List of important documents in GMP • Policies • SOP • Specifications • MFR (Master Formula Record) • BMR • Manuals • Master plans/ files • Validation protocols • Forms and Formats • Records Feb 2018 SKP 25
- 26. 10 attributes of a good document 1. Accurate 2. Clear 3. Complete 4. Consistent 5. Indelible 6. Legible 7. Timely 8. Direct 9. Authentic 10. Authorized Feb 2018 SKP 26
- 27. Certifying agencies • ICH. www.ich.org • WHO. www.who.int • US FDA. www.fda.gov • EU/EMEA. www.emea.europa.eu Feb 2018 SKP 27
- 28. How do GMPs of different countries compare? At a high level, GMPs of various nations are very similar; 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. Feb 2018 SKP 28
- 29. CGMP: •The cGMP acronym originated in the USA, where the US Food and Drug Administration (FDA) wanted to impress upon drug manufacturers the need for continuous improvement in their approach to product quality. The FDA cautioned against a ‘set and forget’ approach to compliance to the GMP guidelines, wanting manufacturers to ensure that product quality became a core driver within their organisations Feb 2018 SKP 29
- 30. cGMP For Finished Pharmaceuticals 1. General Provision 2. Organization & Personnel 3. Building & Facilities 4. Equipment 5. Control of Components & Drug Product Containers & Closures 6. Production & Process Control 7. Packaging & Labeling Control 8. Handling & Distribution 9. Laboratory Control 10. Records & Reports 11. Returned & Salvaged Drugs Feb 2018 SKP 30
- 31. General Provision 1. Scope 2. Definitions Feb 2018 SKP 31
- 32. Organization & Personnel 1. Responsibilities of quality control unit. 2. Personnel qualifications. 3. Personnel responsibilities. 4. Consultants. Feb 2018 SKP 32
- 33. Building & Facilities 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. Feb 2018 SKP 33
- 34. Equipment 1. Equipment design, size, and location. 2. Equipment construction. 3. Equipment cleaning and maintenance. 4. Automatic, mechanical, and electronic equipment. 5. Filters. Feb 2018 SKP 34
- 35. Control of Components & Drug Product Containers & Closures 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. Feb 2018 SKP 35
- 36. Production & Process Control 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. Feb 2018 SKP 36
- 37. Packaging & Labeling Control 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. Feb 2018 SKP 37
- 38. Handling & Distribution 1. Warehousing procedures. 2. Distribution procedures. Feb 2018 SKP 38
- 39. Laboratory Control 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. Feb 2018 SKP 39
- 40. Records & Reports 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. Feb 2018 SKP 40
- 41. Returned & Salvaged Drug Products 1. Returned drug products. 2. Drug product salvaging. Feb 2018 SKP 41