Regulations are becoming more stringent now a days. Compliance with regulations of different countries and the presentation of data accordingly, creates huge workload in chemical and pharmaceutical industries. Harmonization initiatives such as Organization for economic cooperation and development (OECD) and International conference on harmonization (ICH) has led to ease of workload of this sector using mutual acceptance of data (MAD) in a particular format. Recently India has become OECD compliant and thus data generated by Indian GLP compliant laboratories will be considered across all OECD countries. The current article covers overview of good laboratory practices across India with special reference to evolution of GLP compliance history, principles, laboratories, inspection programme etc.
Good laboratory practice (GLP) is defined as a quality system of management controls for research laboratories and organizations in order to ensure the uniformity, consistency, reliability, reproducibility, quality, and integrity of chemical (including pharmaceuticals) non-clinical safety tests; from physiochemical properties through acute to chronic toxicity tests.
Many countries require manufacturers of industrial chemicals, pharmaceuticals, veterinary drugs, pesticides, cosmetic products, food products, feed additives etc. to establish through data that the 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.
GLP is a system, which has been evolved by Organisation for Economic Co-operation and Development (OECD) used for achieving the above goals. Effective GLP implementation leads to generation of high quality and reliable data.
Effective GLP compliance becomes necessary for development of quality test data, mutual acceptance of data, avoiding duplication of data, avoiding technical barriers to trade, and protection of human health and the environment.
Historical perspective
Till 1970s, it was believed by US FDA that data submitted by sponsor companies is accurate, reliable and of high quality. But the case of two major pharmaceutical manufacturers with misleading data caused US FDA to form expert group which was working on standards for measuring performance of research laboratories and forming of enforcement policies. As a result of this OECD was formed in 1978.
Developments in OECD continued leading to development of guidelines of GLP. India, as an emergency economy across the globe, founded National Good Laboratory Practice (GLP) Compliance Monitoring Authority (NGCMA) on April 24, 2002, under the administrative control of Department of Science and Technology, with the approval of the Cabinet. The purpose of this establishment was to help Indian industries to obtain GLP-compliance status for their test facilities, so that data generated by these test facilities is acceptable in the countries of OECD. India became a Provisional Member of the OECD’s working group on GLP in April 2003. In February 14-18, 2010; OECD along with NGCMA carried out evaluation of Indian GLP programme and this resulted in approval of Indian GLP programme by OECD leading to mutual acceptance of data in April 2011.
Consequences of inclusion of Indian GLP programme
- India joined the group of 34 nations from developed countries who have a “fully adherent status”. India is the third emerging economy after South Africa and Singapore to join the OCED member countries.
- No further inspections by member OECD countries, thereby saving time and money involved in multiple inspections.
- Mutual acceptance of data (MAD): Data generated by Indian test facilities would have a validity and acceptability in all OECD countries for review and consideration for registration or licensing of products in the respective OECD member countries.
- Increase in number of contract research facilities further in India leading to enhancement of trade and economy of the country.
Major activities of NGCMA
- Conducting GLP inspections,
- Grant of GLP certificate
- GLP compliance monitoring of certified test facilities (through annual surveillances)
- Awareness generation on GLP
Training on OECD principles of GLP and training of GLP inspectors to maintain a pool of quality inspectors for conducting GLP inspections on behalf of NGCMA.
Areas for which certification of GLP are essential:
GLP-compliance certification for one or more of the following areas of expertise:
- Physiochemical 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
Essential components of GLP:
Written instructions or procedures in English or local languages. Use of approved procedures and instructions.
- Trained operators for performing procedures accurately
- Recording of tests during laboratory activities
- Define and review all laboratory processes
- Qualified and trained personnel
- Correct containers, materials and labels
- Adequate premises and Space.
- Suitable equipment and services.
- Suitable storage and transport.
- Adequate personnel, equipment for all type of in process tests
- Storage and distribution of the products in proper manner to minimize any risks
GLP certification from National GLP Compliance Monitoring Authority
National GLP Compliance Monitoring Authority offers GLP certifications to facilities in India.
This authority acts as an apex body which comprises secretaries of different ministries/departments, Director-General, CSIR and the Drugs Controller General of India as its members with Secretary-DST as its Chairman.
The authority is responsible to ensure that the National GLP programme functions as per OECD norms and principles. The chairman of this authority sets up technical committee on GLP, which provides recommendations to GLP authority and helps the National GLP Compliance Monitoring Authority in evaluating the competence of test facilities on the basis of the inspections organized by the GLP Secretariat.
Empanelled GLP inspectors are approved by the technical committee for assessment of test facility/laboratory. These inspectors evaluate the technical competence of the applicant test facility/laboratory in all respects for its compliance to GLP. Though GLP certification is voluntary for industries, it is essential in order to get product approval easily without conducting studies again for approval in OECD member countries. GLP certification is valid for three years and annual surveillance is done by authorities. Reassessment is done during third year of maintaining certification.
Procedure for obtaining GLP certificationThe test facilities or laboratories should apply in prescribed format available on website of national GLP compliance monitoring authority. After receiving the application, authority conducts pre-inspection of facility by GLP inspectors. Final inspection is conducted after pre-inspection visit. Report of GLP inspection team is forwarded to Technical Committee which recommends facility to be approved to Chairman of National GLP Compliance Monitoring Authority.
GLP inspection check-list for test facilitiesThis check-list involves ten points which should be ensured for compliance with GLP norms. GLP inspectors examine test facilities for these points which are as follows:
- Test facility organization and personnel
- Quality assurance programme
- Facilities
- Apparatus, materials and reagents
- Test systems (physical, chemical and biological)
- Test and reference items
- Standard operating procedures (SOPs)
- Performance of the study
- Reporting of study results
- Storage and retention of records and materials
Current status of GLP compliant facilitiesIndia has around 24 GLP compliant facilities. Out of this six are chemical companies, 15 are pharmaceuticals and three are institutes such as National Institute of Pharmaceutical Education and Research (NIPER), Chandigarh; Indian Institute of Toxicology, Pune and International Institute of Biotechnology and Toxicology (IIBAT), Tamil Nadu. GLP compliance monitoring authority receives many applications for approval or certification for different facilities across India.
Future prospectsIndia, an emerging destination for research, development and manufacturing for chemicals and pharmaceuticals is ready to provide high quality and reliable data from studies conducted. Different regulations regarding pharmaceuticals have been devised and are being effectively implemented across the country. GLP certification from Indian GLP compliance and monitoring authority provides uniqueness to the data submitted for approval to OECD member countries.
As India has been recognized by OECD as a member of the organization, mutual acceptance of data will save money of governments and chemical producers around €150 million every year by allowing the results of a variety of non-clinical safety tests done on chemicals and chemical products, such as industrial chemicals and pesticides, to be shared across OECD and other countries that adhere to the system. This will lead to the growth of contract research sector of India and also to the development as a hotspot for R&D. This will also remove potential non tariff trade barriers between countries for marketing of chemicals and pharmaceuticals.
The author is a pharmacuetical and clinical consultant