Get data in order
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.
Table I: Typical documents requested during FDA preapproval inspections.
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."
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.
Who is at the door?
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.
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).
Don't forget the basics.
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.
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.