GLP and GMP

GLP and GMP

1. M. Pharm. (Quality Assurance) 1 st Sem. MQA 103T- Quality Control and Quality Assurance Lecture 2: GLP & GMP 07-Oct-21 ISF College of Pharmacy, MOGA 1 Balak Das Kurmi Professor Department of Pharmaceutics ISF College of Pharmacy (An Autonomous College), Moga E mail: [email protected]

2. Contents GLP definition History of GLPs Reasons for creation of GLPs Objectives of GLPs GLP v/s GMP GMP definition History of GMPs Reasons for creation of GMPs Objectives of GMPs 07-Oct-21 ISF College of Pharmacy, MOGA 2

3. Good Laboratory Practices (GLPs) GLP is an FDA regulation that embodies a set of principles that provides a framework within which laboratory studies are planned performed, monitored, reported and archived. GLP may be defined as a body of rules, operating procedures, and practices established by a given organization, that are mandatory with a view to ensuring quality and correctness in the results produced by a laboratory. GLP is sometimes confused with lab safety standards like wearing, safety goggles etc. 07-Oct-21 ISF College of Pharmacy, MOGA 3

4. History of GLP GLP is a formal regulation that was created by the FDA (United states food and drug administration) in 1978. In 1981 an organization named OECD (organization for economic co-operation and development) produced GLP principles that are now international standards. 07-Oct-21 ISF College of Pharmacy, MOGA 4

5. R easons, why GLP was created? In the early 70’s FDA became aware of cases of poor laboratory practice all over the United States and decided to do an in-depth investigation on 40 toxicology labs. They discovered a lot of fraudulent activities and a lot of poor lab practices. Examples of some of these poor lab practices found were: Equipment not been calibrated to standard form, therefore giving wrong measurements. Incorrect/inaccurate accounts of the actual lab study. Inadequate test systems. 07-Oct-21 ISF College of Pharmacy, MOGA 5

6. Objectives of GLP Adopt good and safe operating procedures and recording systems. Prevent human errors in the performance of the job. Prevent equipment errors in measurements. Prevent unsafe and hazardous acts which could affect individuals and/or properly. Improve efficient performance of the job. 07-Oct-21 ISF College of Pharmacy, MOGA 6

7. GMP V/s GLP Good Laboratory Practices Samples Laboratory Processes Quality Results of Analysis Good Manufacturing Practices Raw/ Packing Materials Manufacturing Processes Finished Product of Standard quality 07-Oct-21 ISF College of Pharmacy, MOGA 7

8. 07-Oct-21 ISF College of Pharmacy, MOGA 8 Subpart A- Scope, Definition, Applicabilityto studies performed under grants and contracts, Inspection of testing facilities Subpart B- Oraganization personnel Subpart C- facilities Subpart D-equipments Subpart E-Testing facilities operations F-test and control articles G-protocol for and conduct a non clinical laboratory study H- reserved J-Record and reports K-Disqualification of testing facilities

9. Good Manufacturing Practices (GMPs) GMP is also an FDA regulation that embodies a set of principles that provides a framework within which manufacturing activities are planned performed, monitored, reported and archived. GMP may be defined as a body of rules, operating procedures, and practices established by a given organization, that are mandatory with a view to ensuring quality and performance of the product manufactured by following them. GMPs are guidelines on aspects of manufacture like premises, personel , equipment, sanitation, starting material, manufacturing operations, validation, quality control systems and documentation. 07-Oct-21 ISF College of Pharmacy, MOGA 9

10. History of GMP One of the oldest drug laws in USA was a law approved by congress in 1848 that prohibited import of deteriorated and adulterated drugs, later in 1906 first pure food and drug law was approved. In 1962 an amendment to Federal Food and drugs Act called Kefauver Harris Amendments introduced the definition that a drug is to be considered adulterated if the methods used in its manufacture/processing, testing, packing or storing did not conform to Good Manufacturing Practices. As a result first GMPs were published in 1963. 07-Oct-21 ISF College of Pharmacy, MOGA 10

11. History of GMP In UK “ Guide to Good Pharmaceutical Manufacturing Practice” was published in 1971 popularly known as ORANGE GUIDE. Actually in India the Act of 1940 gave powers to government to make rules to regulate import, manufacture sale and distribution of drugs under which rules were framed in 1945. World Health assembly consultant group drafted GMP in 1967 and revised text was published in 1968. By The end of seventies many countries adopted WHO GMP guidelines and in India the concept of GMP was made mandatory by a legislation of 1988 as Schedule M to the rules of 1945. 07-Oct-21 ISF College of Pharmacy, MOGA 11

12. R easons, why GMP was created? Sources of variation in quality need to be controlled and the error may arise at any stage from procurement of raw material to processing, packing and thus testing of final product cannot be relied upon for quality, safety and efficacy of the drugs. Sources of quality variation include: Materials: Different venders, different batches o same supplier and variation within batch. Machines: Variation of equipment, or different setting or controls of equipment, improper care. Methods: Inexact/ inadequate procedures or negligence by chance. Men: Inadequate training, lack of interest, dishonesty, fatigue and improper work condition. 07-Oct-21 ISF College of Pharmacy, MOGA 12

13. Objectives of GMP To produce product confirming to predetermined specifications . To produce product of consistent quality . To prevent and minimize contamination, mix-ups To eliminate errors 07-Oct-21 ISF College of Pharmacy, MOGA 13

14. Literature 07-Oct-21 ISF College of Pharmacy, Moga

15. Short Questions What are GLPs? When and why GLP guidelines came into existence? What are the objectives of GLPs? What are GMPs? Write note on history of GMPs. What are the objectives of GMPs? Describe various source of variation in Quality. Questions 07-Oct-21 ISF College of Pharmacy, MOGA 15

16. 1. Quality Assurance Guide by organization of Pharmaceutical Procedures of India, Volume I & II, Mumbai, OPPI Quality Summit 2018 2. Good Laboratory Practice Regulations, Sandy Weinberg Vol. 69, Marcel Dekker Series 2002. 3. Quality Assurance of Pharmaceuticals- A compendium of Guidelines and Related materials Vol I & II, WHO Publications. 4. How to Practice GMP’s – P P Sharma, 7 th edition, Vandana Publications, Agra. 07-Oct-21 ISF College of Pharmacy, Moga References

17. THANKS For Further Detail/ Suggestions Please Contact ISF COLLEGE OF PHARMACY, MOGA (An Autonomous College) Ghal Kalan, GT Road, Moga - 142001, (Pb.) E- mail: [email protected] 07-Oct-21 ISF College of Pharmacy, MOGA 17