It is an obvious fact that one of the primary objectives of compliance with the principles of Good Laboratory Practice by any test facility is mutual acceptance of data, commonly termed as MAD system. Through MAD system it is intended to avoid duplication of test data among the OECD member countries, besides preventing trade barriers and eventually saving cost to government and industry.
There are timely revisions and updating of the principles of GLP, intended to promote quality and validity of test data used for determining safety of chemicals and chemical products, to account for the scientific and technical progress in the field of safety testing by the Expert Group of OECD members. Normally the revisions brings out new decisions in some of the provisions of the regulations to permit non-clinical testing laboratories greater flexibility in conducting non-clinical laboratory studies without compromising public protection. The recent publication of statement of policy on outsourcing of inspection functions by GLP MA endorsed by the Working Group on GLP at its 20th meeting held on 4th April, 2006, totally reiterates the policy set by the 1989 Council Decision-Recommendation on Compliance with GLP.
There are two key issues that needed to be dealt with clarity with regard to the functionality and decision-making by the GLP MA on GLP certification. The first issue is the certification of the test facilities of the non-member economies, like India (included though she holds the observer status). Test facilities in non-member countries have been conferred GLP certificate on an ad hoc basis by the representatives of GLP compliance Monitoring Programmes in member countries (eg. Germany and the Netherlands) at the request of the local receiving authorities of the test data. While this is explicitly termed only as 'an interim solution' by the OECD Council the question is that what would be the 'GLP status' of the data generated by the test facilities, certified by the member countries, on ad hoc basis?
Though it could be understood that the country that provided the GLP certificate should only accept the data generated by the test facility, the overall objective of the MAD system has been compromised by this practice because the data could not be submitted to any other member countries. In other words, if the other member countries would not accept the data of the GLP-certified lab what value does the certificate hold with regard to the purpose of the MAD system? Moreover, there is also a prevailing chance of misuse of claiming global 'GLP status' by the test facilities that have only been provided with ad hoc certificate.
Second issue is that the non-member economy like India, currently being a provisional adherent to GLP compliance programme and striving to become member country as well, has so far conferred GLP certificate to seven test facilities in India. Usually it takes three to four years to become a valid member country, after being evaluated by the other OECD members, at the end of the provisional period. In such situation, what would be the 'GLP status' of the test data generated by the test facilities certified by the Indian GLP MA, during the course of the provisional period? What is the fate of the data generated so far, should the data be acceptable only after getting full member status? It is relevant that a few sponsors abroad still show reluctance in outsourcing GLP studies to the test facilities because of the current observer status that India holds.
It is appropriate to mention paragraph 3 and point 2 of the policy statement as it is, "more and more test facilities located in economies (like India) which are not yet part of the MAD system are working in compliance with the OECD principles of GLP to meet the regulatory requirements of OECD countries to which they submit data, the need to monitor them for compliance is also growing". Despite the commitment of the Indian GLP Monitoring Authorities and the test facilities striving to comply with the principles of GLP it is a highly pertinent issue to throw clarity on these issues because it is not only the principle but the business as well that matters to any test facility and government bodies as cost and time saving is also the complementary of the principles of GLP.
(The author is senior research scientist - Quality Assurance, Orchid Research Laboratories Limited, Chennai.)