GMB NEW (2).pptx
- 1. By Asnake W. 01/10/20222 1 CURRENT GOOD MANUFACTURING PRACTICES (cGMP) By Asnake W.
- 2. Definitions What is GMP? ⚫ GMP is a common term and its full form is Good Manufacturing Practice ⚫ It 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. ⚫ GMP is that part of Quality Assurance which ensures that medicinal products are constantly produced and controlled to the quality standard appropriate to their intended use. 2
- 3. GMP…. GMP handbooks for every industry. It is concerned with both Production and Quality Control . It’s a magic key that opens the door to quality.
- 4. GMP…. A basic tenet (principle) 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. 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.
- 5. 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 57
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- 7. QA, GMP & QC inter-relationship QA 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. GMP is part of quality assurance which ensures that medicinal products are consistently produced and controlled to the quality standards appropriate to their intended use. 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. 5
- 8. Cont… What is cGMP? cGMP refers to Current Good Manufacturing Practices regulation enforced by USFDA According to FDA: the "C" in cGMP stands for "current," requiring companies to use technologies and systems that are up-to- date in order to comply with the regulations. Systems and equipment that may have been "top-of-the-line" to prevent contamination, mix-ups, and errors. 8
- 9. cGMP 9
- 10. cGMP ⚫ cGMP reminds manufacturer that they must employ the technologies and systems which are up to date in order to comply with the current regulations. 10 ⚫ GMP has to be updated time to time in order to comply with the standard guidelines. ⚫ cGMP is a unique term to define most recent guidelines with improvement and additions.
- 11. cGMP ⚫ Even if any product meets the specification but cGMP is not followed, the product is then considered “adulterated” by the law. ⚫ cGMP provide for systems that assure proper design, monitoring and control of manufacturing processes and facilities. ⚫ It is important to note that cGMPs are minimum requirements. 11
- 12. What is GxP? ⚫A general term for Good Practice quality guidelines and regulations. These guidelines are used in many fields, including the pharmaceutical and food industries. ⚫The titles of these good practice guidelines usually begin with "Good" and end in "Practice", with the specific practice descriptor in between 12
- 13. What is GxP?(continued…) • GxP represents the abbreviations of these titles, where x (a common symbol for a variable) represents the specific descriptor. • Good Automated Manufacturing Practice, or GaMP • Good Clinical Practice, or GCP • Good Distribution Practice, or GDP • Good Documentation Practice, or GDP • Good Laboratory Practice, or GLP • Good Manufacturing Practice, or GMP • Good Storage Practice, or GSP 13
- 14. Why cGMP is important? ⦁ cGMP is important because it is related with the well being of human life. ⦁ A consumer usually cannot detect or understand much about drugs which is safe or if it will work through smell, touch, or sight ⦁ So it is the responsibility of the people involved with this industry to produce quality and safe product and make it available for the people. 14
- 15. Why GMP…. 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. 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
- 16. Importance of cGMP(continued…) Some recent incidents are mentioned as follows; A Local GMP noncompliant incidence: ⦁ Paracetamol Tragedy in Bangladesh in 1991 and 2009 ⦁ Miltefosine fraud in 2008 A very recent scenario in international arena: A British based Multinational giant Pharma has to pay $ 750 million to settle the manufacturing fraud, October, 2010. 16
- 17. Importance of cGMP(continued…) GMP is important because it affects life. Some incidents : • 1960 : The Thalidomide case in Europe….. Thalidomide first entered the German market in 1957 as an over-the-counter remedy, based on the maker’s safety claims. They advertised their product as “completely safe” for everyone, including mother and child, “even during pregnancy,” as its developers “could not find a dose high enough to kill a rat.” By 1960, thalidomide was marketed in 46 countries, with sales nearly matching those of aspirin. • 1970: Following the thalidomide case few regulation were released by congress that company has to ensure not only safety but also the efficacy of the intended use including clinical trial reports 20
- 18. Importance of cGMP(continued…) • 1980 & 1990: A 12 yrs old girl died after taking Tylenol Acetaminophen capsule. Six other people died for the same reason, 3 of them from the same family. • The mfg. company recalled 32 million bottles of the product. The investigation revealed that, a criminal tampered had intoxicated the bottles with Cyanide capsule. • FDA issued the tamper resistant packaging regulations for all OTC drugs. 18
- 20. cGMP covers ALL aspects of production; from the starting materials, premises and equipment to the training and personal hygiene of staff.
- 22. Personnel 22
- 23. Premises 23
- 24. Premises 24
- 25. Premises 25
- 26. Premises 26
- 27. Equipments 27
- 28. Sanitization 28
- 30. Raw Materials 30
- 31. Self Audit and Inspection 31
- 32. PACKAGING & LABELING CONTROL 32
- 33. PACKAGING & LABELING CONTROL 33
- 36. Conclusion From the above discussion we can conclude that Pharmaceutical Industry is regulated by GMPs Good Manufacturing Practices must be followed GMPs ensure drug products are safe, pure and effective.
- 38. Assignment-2 1. Introduction: general mechanisms of drug release from dosage forms and types of modified release dosage forms: 2. Physicochemical &Biological Considerations in the Design of Modified Release Dosage Forms. 3. Designs, development and characterization of modified release dosage forms. Approaches based on drug modification Approaches Based on Dosage Form Modification 4. In vitro/In vivo evaluation of modified release dosage forms
Editor's Notes
- #8: Ancillary spaces are spaces that help support the main function of a building
- #17: The drugs, manufactured at the plant between 2001and 2005, are Kytril, Bactroban, Paxil CR and Avandamet. Kytril is a sterile anti-nausea medication. Bactroban is a topical anti-infection ointment commonly used to treat skin infections. Paxil CR is the controlled release formulation of the popular anti-depressant drug, Paxil, and Avandamet is a combination Type II diabetes drug.