Preparing for FDA Inspections in a Changing Regulatory Environment - Pharmaceutical Technology

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Preparing for FDA Inspections in a Changing Regulatory Environment
Industry and regulatory experts provide advice on inspection preparation and best practices.


Pharmaceutical Technology


Get data in order


Table I: Typical documents requested during FDA preapproval inspections.
Table I outlines the most common documents FDA will request during a PAI, including those that are CGMP requirements and those that are not necessarily required by CGMPs but that will be expected. An inspection team should not be given access to financial documents such as sales or revenue reports or forecasts, internal and supplier audit reports, or personnel files, except for employee education and training information.

Have an organizational chart on hand as well, suggests Garvey. "A facility diagram that is coded by environmental control area can help the agency get an idea of where they are when doing plant tours, what the controls in those areas are and how they relate to product manufacturing builds."

Review SOPs


Who is at the door?
Reviewing and updating standard operating procedures will not only help the inspection team understand how things operate but also will provide staff with a refresher course on protocol and procedure. This will enable them to better discuss and explain systems when asked.

Carry out a mock inspection

The best way to prepare for an FDA inspection is to carry out a mock inspection ahead of time.

Set a timeframe. It's best to carry out an inspection close enough to the scheduled inspection that all the data and procedures are fresh but far enough ahead of time that one can correct any errors or make any adjustments before the big day, advises P. Smith. This is generally about six to eight months before the scheduled inspection.


Don't forget the basics.
Make staff assignments. Inspections are a mobilization effort, and all personnel must know what his or her role will be and what is required. "It's important to assign a trained, key employee to each subject area to the PAI such as management responsibility, R&D, pilot plant, the water system, validation, production, engineering, laboratories, quality, change control, and regulatory affairs," advises Chinny C. Okparanta, president of Integrated Quality Systems (Edison, NJ).

Ideally, an internal readiness team made up of personnel with FDA inspection experience and who have interfaced with FDA investigators or were on the regulatory side of the industry is important. "All strategy should be driven by this core team of people who know how to manage the process," says Medina.

Practice interviewing. Surprisingly, a number of inspection failures have less to do with actual facility management and more to do with simple misunderstandings. Although contract manufacturers are constantly going through customer audits and thereby are accustomed to answering questions and retrieving documents, other companies may have very complex systems to explain that are new to an FDA inspector. Staff must be able to explain everything in basic terms, with flow charts and summaries to demonstrate systems.

"Often times, the staff is so familiar with the subject matter that they don't understand the investigator hasn't been to the plant before and may not understand certain terminology," says P. Smith.


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