Thursday, September 16, 2010

Schedule L1, GLP on board !

Thanks to Mr Shirgaonkar for this wonderful information !
Knowledge of Good Laboratory Practices is very important in Pharmaceutical industry.
New GLP requirements as per Schedule L1 of Drug Rules will come into effect from 1st November 2010. Topics such as General laboratory requirements,instruments calibration, microbiological testing and internal audit will be covered in this statutory requirement.
It was announced that Ministry of Health has recently notified the Schedule L-1 of Rule 74,78 and 150 E under Drugs and Cosmetics Third Amendment Rule 2008 giving the pharmaceutical industry time till November 1, 2010 for compliance.
The implementation of GLP and the responsibility of companies to comply with them while carrying out quality analysis. GLP stresses on the maintenance of documented quality systems as per the quality manual laid down by the manufacturing unit, and on the technical audit of the quality control laboratory for GLP compliance by an expert/experts appointed by the top management other than the person in charge of the laboratory.
As Mr. Shirgaonkar organises a workshop on GLPs and highlight the incumbent Schedule L1, to know more visit Insight Systems website

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