The Food and Drug Administration (FDA), Maharashtra is planning to organise a sensitisation programme on Schedule L-1 for small scale manufactures in Mumbai and Thane in November. Through this programme, FDA plans to spread the importance and necessity of following the good laboratory practices (GLP) requirements as per Schedule L-1.
The objective of the programme is to inform the the small scale manufacturers in Mumbai and Thane about the importance of the implementation of GLP and to train them about the same. According to P R Uttarwar, joint commissioner, Maha FDA, “Knowledge of good laboratory practices is very important in pharma industry. It is important for them to follow the new GLP requirements as per Schedule L-1 of Drug Rules which is going to be operational soon, failing which we would be forced to cancel their licences.”
The FDA' wanted to make sure that all the companies, large as well as small scale manufacturers, are made aware of the new GLP requirements and follow it accordingly as it is the responsibility of the companies to comply with them while carrying out quality analysis. However, the small and medium scale pharmaceutical units are not so keen in upgrading the lab facilities to comply with the GLP norms due to the huge investments required for upgrading the manufacturing facility. In fact there have been demands from some section of the industry demanding postponement of the present deadline by two years to November 1, 2012.
The new GLP requirements as per Schedule L-1 of Drug Rules will come into effect from November 1, 2010. The Ministry of Health had notified the Schedule L-1 of Rule 74, 78 and 150 E, under Drugs and Cosmetics Third Amendment Rule 2008 giving the pharma industry time till November 1, 2010 for compliance. General laboratory requirements, instruments calibration, microbiological testing and internal audit are covered in this statutory requirement.
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 experts appointed by the top management other than the person in charge of the laboratory.
FDA officials informed that soon after the completion of the sensitisation programme in Mumbai and Thane, they would conduct similar programmes in Pune, Nashik and Aurangabad as well.