Senior government officials, including the drug controller general of India (DCGI), have allayed the fears of the industry on implementation of the Good Laboratory Practices (GLP) which will become mandatory in the country from November 1, 2010. The officials presented a roadmap for implementation of the GLP at a seminar in Chandigarh on May 30.

At the seminar, the officials showcased the roadmap for implementation of the GLP and made several presentations to guide the industry to follow the government guidelines. The seminar was organized by the Federation of Pharmaceutical Entrepreneurs (FOPE), an organization comprising hundreds of pharmaceutical units in the tax-free zones in Himachal Pradesh and Uttarakhand.

Apart from DCGI Dr Surinder Singh who was the chief guest of the seminar, National GLP committee chairman and eminent pharmacologist Dr YK Gupta was also present in the seminar. Other officials who were also present in the seminar included CDL, Kolkata, director PK Guha, Haryana drug controller RM Sharma, Himachal Pradesh drug controller Navneet Marwaha, Uttarakhand drug controller DD Upreti, Solan drug licensing authority RK Choudhury and Dharamshala drug licensing authority Kapil Dimant.

FOPE chairman BK Gupta, co-chairman BR Sikri and IDMA president NR Munjal were also present in the seminar in which more than 200 delegates from industry participated. The seminar was an opportunity for the industry to clear their doubts about the implementation of the GLP. After the presentations on GLP, there was an open house session in which the officials answered all the questions raised by the industry.

The main objective of the seminar was 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.

The seminar was an effort to allay the apprehensions among the industry on implementation of the GLP in the country. There are apprehensions among the industry about the need for the implementation of the GLP. The seminar titled 'GLP----broad overview' deliberated on the implementation of the GLP in the country.

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.