Category Archives: Lab Services

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“Good Laboratory Practice (GLP) has already been implemented mostly in the developed countries and even in some developing countries. Though it is not mandatory in India but some manufacturers have already implemented the concept voluntarily and very recently a step has been taken by the Government of India to implement GLP on and from 1st November 2010.
GLP generally refers to a system of management controls for laboratories and research organisations to ensure the consistency and reliability of results as outlined in the Organisation for Economic Co-operation and Development (OECD) principles of GLP and national regulations. It applies to non-clinical studies conducted for the assessment of the safety of chemicals to man, animals and the environment, but it does not include clinical research.
GLP in India (Schedule-L 1): The Government of India has notified GLP as mandatory vide G.S.R.780 (E) dated 10th November 2008 under schedule “”L-1″” with effect from the 1st day of November, 2010. This includes requirements in details about general requirements, premises, personal, equipments, chemicals and reagents, good housekeeping and safety, maintenance, calibration, and validation of equipments, Reference materials, quality system, Internal quality system audits, management review, standard operating procedures, protocols and specifications archive, raw data, storage and archival, Most of the GMP complied companies have already improved their laboratories during compliance of Schedule-MA major part of the GLP requirements have covered by the revised Schedule M especially under section 5 and 6 of the same.”

As the DCGI takes steps to streamline polices related to lab sample exports, the same are being formulated so that CRO’s and Pharmaceutical companies comply with the norms within the country as well as outside the country. Compliance to lab regulatory norms relating to export is becoming an important aspect and a matter of extreme business importance as far as outsourcing of laboratory services is concerned. For a sponsor (Pharma /biotech) to outsource his sample analysis to India, a complete compliance starting from the shipment to the testing up to the final results remains within the stipulated regulatory norms as desired.

Indian CRO’s which have extensive capabitiles in small molecule Pk as well the desired equipment, expertise and the capacity to handle large volumes of sample analysis on an ongoing basis would be able to find their place in the outsourced bio analysis market in India. It is difficult to estimate the existence or the size of the bionalaysis market. It can only be estimated form the sales of the life science instrumentation market to India.

Veeda Clinical Research is an Indian CRO which provides cost effective lab services to the drug industry. Veeda CR’s on-site laboratory was established in 2004 as a purpose built facility to serve the clinical trials industry. The laboratories offer a truly world class facility providing a bioanalytical laboratory services for the analysis of drugs and metabolites for small molecules.
The laboratory is equipped with MDS-Sciex Mass spectrometers and Shimadzu HPLC systems. These are supported by Tomtec Quadra 96 robotics allowing automation of extractions and analysis on 96-well microplates. The whole service is underpinned using

WATSON LIMS©