OECD GLP and FDA Regulations: Who is Who ?
Working global also means understanding the different regulatory authorities. We all know the OECD term and FDA authority, but do we really know the Technical and legal difference between both authorities ? do you Know how the one may impact your SOP within a multisite setting ? Before Answering these tricky questions, I would like to thank my professional association ‘the society of Quality assurance professionals’ giving me the tools to understand. Feel free to send me your questions ! Feel free to Visit the SQA website for additional materials; as well my keynote lectures on various subjects.
OECD Principles of GLP were largely based on the FDA 1978 GLPs, and were recommended for use in OECD member countries by the OECD Council in 1981. They were updated in 1997, and were set out in Annex II as an integral part of the Council Decision on Mutual Acceptance of Data (MAD). The Assessment of Chemicals states "data generated in the testing of chemicals in an OECD Member country in accordance with OECD Test Guidelines and OECD Principles of Good Laboratory Practice shall be accepted in other Member countries for purposes of assessment and other uses relating to the protection of man and the environment."
OECD GLP principles are not a law unless they are adopted as a whole or with specific modifications by a member country's national government. The OECD GLP Principles (and other documents) may be useful information for US firms; however, no OECD documents have any legal status in the US. Other OECD GLP document types are issued, in descending order of importance, as Consensus documents (input by regulators and industry), Guidance and Advisory documents (input by regulators), Position Papers, and Frequently Asked Questions. The OECD #21 Position Paper reflects the OECD GLP Working Group's current opinion. The OECD GLP Working Group includes OECD member country representatives, including FDA and EPA representatives.
The US is a full adherent GLP member country of OECD. Studies conducted in the US in compliance with the FDA/EPA GLPs shall be accepted by full adherent and provisional adherent OECD member countries. An important difference of note is that test facilities in other OECD-member countries, and full adherent countries as per OECD provisions, are certified by their respective monitoring authorities and receive a certificate. Firms inspected by US FDA/EPA are not certified, and no certificate is issued. FDA/EPA routinely conduct study-based inspections of facilities after a GLP study that includes a claim of GLP compliance made by a sponsor has been submitted to the agency. Evidence of inspection includes, but is not limited to, a 483 (if any violations were identified) and an Establishment Inspection Report (EIR).