FDA reviewers and inspectors to forge closer links

By Gareth Macdonald

- Last updated on GMT

Related tags: Inspection, Evaluation, Food and drug administration

The US Food and Administration says that a new project examining the interaction between its review and facilities inspection arms will help improve inter-departmental communication, particularly during pre-approval inspections (PAI)

The FDA's PAI programme is designed as a late-stage check to ensure that manufacturing facilities are up to code prior to the issuance of final marketing approval. The agency explained that the first stage of the process had been improving the integration of its field operations into the overall regulatory review.

The program will see the ORA and the FDA's Offices of Generic Drugs (OGD) and New Drug Quality Assessment (NDQA) team up to assess various knowledge and communication solutions that have been proposed. In practice, this means that any questions that arise during the PAI inspection process will be passed on to an inspector for a response before the review is completed.

The overall aim of the study, which was unveiled by FDA manufacturing and product quality director Richard Friedman at the International Society for Pharmaceutical Engineer's (ISPE) regulatory conference, is to establish a formal communication procedure for use during regulatory review.

Friedman explained that the FDA is "working on a pilot to test these procedures and hopefully ... you're going to see a stronger link between the center and ORA [Office of Regulatory Affairs] operations and thus a more effective regulatory system overall​."He went on to say that the agency will consult with investigators, specifically asking them to focus inspections on areas where data may be lacking, including "overall manufacturing control strategy raises issues that need inspectional evaluation or the manufacturing concept includes apparent weaknesses​."

Expansion of pharmaceutical inspectorate

The FDA will also use the project to further the scope of its pharmaceutical inspectorate, which is a specialist group of inspectors that conduct field analysis of manufacturing facilities. At present there is an 11-strong team that the agency hopes to increase to around 50 personnel by the end of the project.

Given that regulatory bodies worldwide, and in particular the FDA, are being stretched thin by their increasingly challenging global remit this expansion could play an important role in easing the pressure.

Related topics: Regulatory & Safety, QA/QC

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