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National Good Laboratory Practice (GLP) Compliance Monitoring Authority (NGCMA)

A number of countries require manufacturers of industrial chemicals, pharmaceuticals, veterinary drugs, pesticides, cosmetic products, food products, feed additives, etc., to establish through data that use of these products do not pose any hazards to human health and the environment. Non-hazardous nature needs to be established through studies and data, which will be examined by the regulatory authorities of the concerned countries. Good Laboratory Practice (GLP) is system used for achieving these objectives.

National GLP Compliance Monitoring Authority (NGCMA) was established by the Department of Science & Technology, Government of India, with the approval of the Union Cabinet on April 24, 2002. India is full-member for Mutual Acceptance of Data (MAD) in the OECD's Working Group on GLP w.e.f March 3, 2011. As a consequence, the data generated by Indian GLP laboratories is acceptable in all the OECD member countries. This facilitates export of chemicals, drugs, pesticides etc. to these countries.

The National GLP Programme functions through an Apex Body, represented by Secretaries of concerned Ministries/ Departments and the Drugs Controller General of India with Secretary, DST being its Chairman. This Apex Body overseas that the National GLP Programme functions as per OECD norms and principles. The Apex Body is supported by Technical Committee on GLP, which is a recommending body of NGCMA on various technical matters concerning GLP.

To meet the increasing demand of GLP compliance monitoring in the country, NGCMA has 15 trained GLP Inspectors from various public funded institutions to evaluate the technical competence of the applicant laboratory in all respects for its compliance to OECD Principles of GLP and OECD Test Guidelines.

GLP certification is voluntary in nature. The test facilities/laboratories have to submit the prescribed Application fee and apply in the prescribed application form of NGCMA. A pre-inspection of the laboratory is carried out by the GLP inspectors, followed by a final inspection. The report, prepared by the inspection team, is considered by Technical Committee whose recommendations are placed before Chairman, NGCMA for a final decision. GLP Certification is valid for a period of three years and the GLP Secretariat organizes surveillance at 18 months from the date of certification and a re-assessment during third year for maintaining the certification.

Industries/test facilities/laboratories, dealing with chemicals listed in para above and conducting safety studies for submission to Regulatory Authorities, can apply to NGCMA for obtaining GLP Certification in one or more of the following areas of expertise:

• Physical-chemical testing
• Toxicity studies
• Mutagenicity studies
• Environmental toxicity studies on aquatic and terrestrial organisms Studies on behaviour in water, soil and air, bio-accumulation
• Residue studies
• Studies on effects on mesocosms and natural ecosystems
• Analytical and clinical chemistry testing
• Others (please specify)