In the pharmaceutical industry, both FDA and OECD implement GLP (Good Laboratory Practice) guidelines aiming to ensure the quality and integrity of non-clinical safety studies. However, there are some key similarities and differences to consider:
Similarities:
Overall Goal: Both aim to produce reliable data for evaluating the safety of products like drugs, food additives, and medical devices.
Core Principles: Both emphasize similar principles such as:
Organizational process for conducting studies
Qualified personnel and training
Proper facilities and equipment
Quality control procedures
Accurate recordkeeping and reporting
International Acceptance: Studies conducted under either FDA GLP or OECD GLP are generally accepted by regulatory bodies worldwide.
Differences:
Scope:
FDA GLP: Applies to studies submitted to the FDA for approval of products regulated by the agency.
OECD GLP: Has a broader scope, encompassing studies submitted to various regulatory authorities across OECD member countries.
Level of Detail:
FDA GLP: Generally considered more detailed and specific in its requirements. The FDA provides a formal regulation outlining the expectations.
OECD GLP: Provides a set of principles, allowing for some interpretation and flexibility by member countries. Specific details might be elaborated upon by national regulations.
Inspections:
FDA GLP: Facilities conducting studies for the FDA may be inspected by the agency.
OECD GLP: Inspections are performed by national bodies adhering to OECD GLP principles.
Choosing Between FDA GLP and OECD GLP:
The choice often depends on the intended use of the study data.
If the study results are solely for internal research or intended for submission to the FDA for approval, following FDA GLP regulations is recommended.
If the data is intended for submission to regulatory bodies in multiple OECD countries, following OECD GLP principles ensures wider acceptance.
Here are some resources for further exploration into the detail.
Comparison Chart of FDA and EPA Good Laboratory Practice (GLP) Regulations and the OECD Principles of GLP: https://www.fda.gov/media/75819/download
OECD Principles on Good Laboratory Practice (GLP): https://www.oecd.org/chemicalsafety/testing/overview-of-good-laboratory-practice.htm