Basic cGMP
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The document discusses key aspects of current good manufacturing practices (cGMP) for pharmaceuticals. It defines cGMP and explains that the "C" stands for "current," meaning manufacturers must use up-to-date technologies and systems. cGMP covers all aspects of production from facilities, equipment, personnel, packaging, quality control, and documentation. Following cGMP is important because it helps ensure the quality, safety and effectiveness of drugs. Historical incidents like the thalidomide tragedy and Tylenol tampering case demonstrate how non-compliance with GMP can put patients' lives at risk.
Basic cGMP
- 1. BISHNU PADA SARKER 6/24/20201 BASIC CURRENT GOOD MANUFACTURING PRACTICES (cGMP)
- 2. Definitions 6/24/20202 What is GMP? GMP is a common term and its full form is Good Manufacturing Practice 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. It is concerned with both Production and Quality Control . It’s a magic key that opens the door to quality.
- 3. HOW MANY GMPs? British GMP-Good Pharmaceutical Manufacturing Practice (GMP) United States GMP-Current Good Manufacturing Practices for Finished Pharmaceuticals (cGMP) WHO GMP-Good Practices in the Manufacture and Quality Control of Drugs ASEAN GMP-ASEAN Good Manufacturing Practice of Drugs 6/24/20203
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- 5. 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 that part of Quality Assurance aimed at ensuring that products are consistently manufactured to a quality 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 6/24/20205
- 6. Definitions 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 10 or 20 years ago may be less than adequate by today's standards. 6/24/20206
- 7. Why c is small? c is a variable in cGMP that’s why it is written in small letter just like pH…p is variable potential in pH 6/24/20207
- 9. cGMP 6/24/20209 cGMP reminds manufacturer that they must employ the technologies and systems which are up to date in order to comply with the current regulations. 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.
- 10. cGMP Even if any product meets the specification but cGMP is not followed, the product is then considered “adulterated” by the law. It is important to note that cGMPs are minimum requirements. 6/24/202010
- 11. 6/24/202011 The Code of Federal Regulations (CFR) is the codification of the general and permanent rules and regulations (sometimes called administrative law) published in the Federal Register by the executive departments and agencies of the federal government of the United States. The CFR is divided into 50 titles that represent broad areas subject to federal regulation. Title 21 is the portion of the Code of Federal Regulations that governs food and drugs within the United States for the Food and Drug Administration (FDA), the Drug Enforcement Administration (DEA), and the Office of National Drug Control Policy (ONDCP).
- 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 6/24/202012
- 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 6/24/202013
- 14. Essence of cGMP for pharmaceuticals product 6/24/202014 Initially- the assurance of the quality of the medicinal product. Ultimately- the safety, well being and protection of the patient.
- 15. History of GMP & cGMP 6/24/202015 THE 1940s AND 1950s In 1941 nearly 300 people were killed or injured by one company’s sulfathiazole tablets, a sulfa drug contaminated with the sedative, Phenobarbital. That incident caused FDA to revise manufacturing and quality control requirements, leading to what would later be called GMPs.
- 16. History of GMP & cGMP (Continued…..) 6/24/202016 • 1963 GMPs for Drugs (28 FR 6385) Good manufacturing practices for manufacturing, processing, packing, or holding finished pharmaceuticals were first published. • 1975 CGMPs for Blood and Blood Components Final Rule Established minimum current good manufacturing practices for blood collection, processing, compatibility testing, storage and distribution.
- 17. History of GMP & cGMP (Continued……) • 1976 Medical Device Amendments Tragedy: the Dalkon Shield IUD seriously injures many patients. Response: New law strengthens FDA authority to oversee medical devices. • 1978 cGMPs for Drugs and Devices (21 CFR 210–211 and 820) A major rewrite for the drug GMPs and GMPs for medical devices were published. These regulations establish minimum current good manufacturing practices for manufacturing, processing, packing, or holding drug products and medical devices. 6/24/202017
- 18. Importance of cGMP GMP is important because it is related with the well being of human life. It is developed to cure people from illness. General people do not understand much about drugs. 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. It affects business and reputation. Some recent incidents are mentioned on next slide. 6/24/202018
- 19. Importance of cGMP(continued…) 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. 6/24/202019
- 20. 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. 6/24/202020
- 21. 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. 6/24/202021
- 34. Self Audit and Inspection 6/24/202034
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- 42. HVAC 6/24/202042
- 43. HVAC 6/24/202043
- 44. HVAC 6/24/202044
- 45. HVAC 6/24/202045
- 57. Ten Principles of GMP 1. Design and construct the facilities and equipments properly 2. Follow written procedures and Instructions 3. Document work (give more paper) 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 6/24/202057
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- 59. Thank You