Union ministry of health has 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.
Under the notification of the Ministry of Health and Family Welfare, Department of Health, No G.S.R.634(E), sections 12 and 33 of the D&C Act, has now inserted ‘Good Laboratory Practices’ as in Schedule L-I and in Rule 78, in clause (p), and in Rule 150 E, in clause (a).
With Schedule L-I of Rules 74, 78 and 150 E, all pharmaceutical companies will need to adhere to Good Laboratory Practices (GLP) and have the necessary requirement of premises and equipment. Pharma companies need to speed up to upgrade the systems and there is a need for comprehensive technical sessions on similar lines like Schedule M to create massive awareness on the importance of the compliance, Kaushik S Desai, chief executive officer, Global Pharmatech told Pharmabiz.
GLP will now call upon all laboratories and organization carrying out testing, calibration, validation, 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.
In the case of premises, 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.
The laboratories should be provided with adequate lighting and ventilation. All bio-medical laboratory waste should be destroyed according to the provisions of the Bio-Medical waste (Management and Handling) Rules, 1996.The Animal House should have the approval of the Committee for the Purpose of Control and Supervision on Experiments on Animals (CPCSEA).In case of a diseased animal, proper diagnosis shall be done and proper record of treatment shall be maintained.
In the case of equipment, the laboratory should be furnished with all types of equipments to carry out the different activities within the laboratory. The analytical instruments must be housed in dust-free environment and whenever required, conditions of temperature and humidity should be maintained .The instruments, instrument bench and surrounding areas shall be kept clean and tidy at all times.
Further, Instruments requiring calibration must be calibrated at regular intervals and records of such calibration should be provided under Standard Operating Procedures.
Other areas that will need to be observed under GLP practices include storage of chemicals, reagents, good house keeping and safety. Quality systems, any time preparedness for audits, management review, maintenance of protocols and specifications archive are be adhered to.
Currently only large pharmaceutical companies and labs in the state have adhered to GLP norms. A dedicated Schedule under D&C will bring about stringent quality practices which are much-wanting when India is a hub for contract research activities, according to members of Karnataka Drugs and Pharmaceutical Association
Source : ePharmail of Pharmabiz.com. For more info, visit http://www.pharmabiz.com.