Abstract
On June 23, 2000, the Government of India issued GSR No. 560(E) under Rule 157 of the Drugs and Cosmetic Rules, and on March 7, 2003, GSR No. 198(E) revised Good Manufacturing Practices (GMP). These rules were made necessary for all new ASU drug manufacturing facilities on June 23, 2000, and for existing units on June 23, 2002. (2 years grace period was given for existing ASU units to obtain GMP certification). The criteria for production premises and hygienic conditions are outlined in Schedule T. The fundamental goal of implementing Schedule-T was to ensure that producers maintained a consistent level of hygiene. Good manufacturing practises must be followed at all times. For all the manufacturers of ASU drugs. Compliance to Good manufacturing Practices is mandatory for all the manufacturers of ASU drugs.
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