Good Laboratory Practices is a newly introduced schedule in the Drugs & Cosmetics Rules from last November 1 and these practices were not addressed as a legal requirement until then. Now if the labs are not conforming to GLP, they may attract administrative or penalty said Kapil Bhargava, vice-chairman of Regulatory & Technical Sub-committee of Indian Drug Manufacturers Association (IDMA).
He was addressing a scientific workshop on Good Laboratory Practices, Schedule L1 organised by IDMA Tamil Nadu branch in Chennai.
The Centre notified GLP as mandatory on November 10, 2008 under Schedule L 1 with effect from 01-11-2010. This includes requirements in details about general requirements, premises, personnel, equipments, chemicals & reagents, good housekeeping & safety, maintenance, calibration & validation of equipments, reference materials, quality system, internal quality system audits, management review, standard operating procedures, protocols & specifications archive, raw data, storage and archival.
Though some of the manufacturers have already made their laboratories GLP compliant, most of the small and medium companies are not aware of the provisions of Schedule L1, according to an expert while chatting with Pharmabiz.
Amar Kumar Kasthuri, Head-Quality Control, Edict Pharmaceuticals, Chennai, while speaking on Good Documentation said the laboratory must establish and maintain procedures to control and review all documents that form part of the quality documentation. He emphasized the need for an errorless, palpable and easy-to-follow laboratory record as different laboratories are supported by different technical staffs and managers, but everyone should follow what others do in every stage of generation of results. He said the original observations, calculations, the data derived, reports on calibration, validation, verification reports and final results must be retained on record for an appropriate period of time as per national regulations. The records for each test must contain sufficient information to permit repetition of tests. According to him documentation is an essential part of the quality system and an important part of accreditation process.
In the afternoon session, J L Sipahimalani, chairman of the Quality Management and Regulatory & Technical Sub-committee of the IDMA spoke on Samples Management systems.
S V Veeramani, vice-president of IDMA southern region has announced the celebration of IDMA golden jubilee which is to be held in Ahmedabad in September 2011. Later he told Pharmabiz that IDMA would conduct free medical camps in Chennai and another two seminars as part of its golden jubilee celebration.
The workshop provided the participants in-depth knowledge about the theme and facilitating them to interact with experts in pharma, science and technology areas. IDMA has organised the workshop as part its golden jubilee celebrations.