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By Robbie Boyle, Quality Assurance Manager in Good Laboratory Practice (GLP)
Sponsors may oversee Good Laboratory Practice (GLP) studies whereby a given study spanning international and local regulations completes without an in-person inspection. How do you provide adequate oversight on this study scenario while reducing the risk of regulatory rejection, a potential and catastrophic result if the proper actions are not taken to address risks?
Sponsors need to be fully aware of the regulatory requirements of their chosen GLP site and how that impacts potential submissions to the regulatory authorities such as the FDA/MHRA and EMA. Further to this, within GLP, there can be additional local laws and requirements beyond global regulatory body requirements are required. This would include examples such as the UK Good Laboratory Practice Regulations 1999, but also international requirements such as Organisation for Economic Co-operation and Development (OECD) Good Laboratory Practice. These can often be described in consensus and advisory documents requiring thorough time dependent review.
The OECD GLP requirements are applicable to several different countries including but not limited to: France, Italy, Ireland, Japan, Australia and Canada, et cetera. Allowance for the OECD Principles are a common requirement for GLP facilities within the OECD compliant countries to follow. The USA while also being an OECD country additionally has the FDA CFR part 58 regulation which sees USA GLP facilities required to comply with, but with the Mutual Acceptance of Data (MAD) OECD countries, including the USA GLP studies performed in these countries can be submitted to their relevant regulatory body without issue.
With this framework the sponsor holds the responsibility themselves that the work being performed is in compliance with regulations both at a local, federal or greater regulatory level. In recent years several updated OECD consensus, advisory and position documents have been released (Data Integrity, Quality Assurance and GLP and Quality Improvements) to aid in the quality and integrity of the study and data for global acceptance. Sponsors in advance of the need to ensure that the chosen facility complies with these requirements. When a study is submitted to a regulatory authority, the receiving authority may ask for the regulator of that country where the data was generated, to assess the facility on their behalf. Thus, to ensure a seamless regulatory submission a sponsor should ensure that the work performed is in compliance with the local and relevant international regulation.
Sponsors are naturally not restricted to perform their GLP studies within their country of origin. Ensuring that GLP studies are designed to be compliant against the international and local requirements then becomes a strategic exercise if the facility performing the study work is not inspected. Further to this, a global dynamic regulatory environment poses a second, equally critical challenge to sponsors staying compliant to the latest updates to global laws which govern clinical trials.
The preventative measures to ensure successful regulatory submission is to primarily have staff with right expertise to ensure prior to GLP study initiation. If there isn’t the adequate global knowledge in place within your team, bring in additional global knowledge. It is critical to then identify the appropriate regulations both from a global regulatory authority standpoint, and at a local level are identified, documented and implemented . Then, from there, it is to ensure the study facility is compliant through detailed review and audit of their documentation and certificates.
Robbie Boyle M.Sc, has deep expertise in the field of Good Laboratory Practice. He has a Master of Science in Cardiovascular Science from the University of Glasgow. Since then he has audited globally, gaining expertise across regulatory jurisdictions and ensuring compliance to local standards and law.