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Abstract

CURRENT GOOD LABORATORY PRACTICES IN PHARMA INDUSTRY

Ganesh Surkute* Gholve S. B., Santosh Kamble, Sayyed Sarfaraz Ali, Ranjana Suryawanshi

ABSTRACT

Good Laboratory Practice (GLP) is a quality system concerned with the organizational process and conditions, under which a study is planned, performed, monitored, recorded, archived and reported. The role of GLP is the development of quality test data, mutual acceptance of data avoids duplication of data, avoids technical barriers to trade and also protection of human health and the environment. GLP is sometimes confused with the standards of laboratory safety like wearing safety goggles. GLP is a regulation that was created by the FDA (United states food and drug administration) in 1978. FDA decided to do an in-depth investigation on 40 toxicology labs. The principles of GLP are complied with a sufficient number of qualified personnel, appropriate facilities, equipment and materials are available. Records of qualifications, job descriptions, training and experience of personnel are maintained. It involves a number of good practices in the QC laboratory which are to be undertaken to carry out ananalysis with a defined degree of accuracy and precision. GLP and cGMP regulations have a significant impact on the daily operation of an analytical laboratory. GLP was altered to protect the integrity and quality of laboratory data used to back up a product application.

Keywords: Regulatory Authorities, Quality Control, 21 CFR.


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