In an effort to allay the apprehensions among the industry on implementation of the Good Laboratory Practices (GLP) in the country, the Federation of Pharmaceutical Entrepreneurs (FOPE), an organization comprising hundreds of pharmaceutical units in the tax-free zones in Himachal Pradesh and Uttarakhand, will organise a one-day seminar on GLP in Chandigarh on May 30. DCGI Dr Surinder Singh is expected to be the chief guest in the seminar.
FOPE co-chairman BR Sikri said that there are apprehensions among the industry about the need for the implementation of the GLP. The seminar titled 'GLP----broad overview' will deliberate on the implementation of the GLP in the country. The main objective of the seminar is to create awareness among the industry on the need to comply the GLP and how to implement it. Union ministry of health had recently notified the Schedule L-I of Rules 74, 78 and 150 E under Drugs and Cosmetics Third Amendment Rules 2008 giving the pharmaceutical industry time till November 1, 2010 for compliance of Good Laboratory Practices.
Sikri said that apart from the DCGI, the licensing authorities of the region will also be attending the seminar. Besides, hundreds of delegates from across the country will also be participating in the seminar.
As per the GLP, all laboratories and organizations carrying out testing, calibration, validation, etc have to adhere to Schedule L-I. The management of the labs should have a team of qualified personnel, known as quality manager or technical manager to carry out all technical activities for the implementation of documented quality system. The teams will need to prepare a schedule for technical audit of the laboratory for GLP compliance by an expert or experts appointed by the top-management other than the in-charge of the laboratory.
As far as the premises are concerned, the GLP specifies that the laboratories should be designed, constructed and maintained to prevent entry of insects and rodents besides cross contamination; interior surface including walls, floor, and ceilings, which should be smooth and free from cracks. It should also permit easy cleaning and disinfection. Adequate provision is made not only for space and equipment for carrying out necessary test but also for utilities like water, power and gas. The air ventilation system shall ensure dust free environment.