How to Prepare For FDA Inspection – Rules of the Road
Rule #1: Always be Prepared for FDA Inspections
It is very apparent when things are prepared just prior to an audit or hastily put together during the audit. Fresh paint over poorly prepared material or all documents very recently signed are obvious indicators that hurried work was performed.
Most inspections in the United States are not announced. If the inspection is to be performed outside the United States, then the FDA usually calls to arrange a time and date.
Rule #2: A Place for Everything and Everything in Its Place
First impressions are very important. Not only should everything be stored properly, there should be a written procedure for cleaning and sanitation of the facility. There should also be a preventive maintenance program to ensure proper upkeep. You should prepare for FDA inspections because if an auditor is witness to the following, there will be more questions and “drilling” into systems to determine compliance:
Rule #3: Be in Compliance with Observations from Previous Audits
Verify that the observations from prior audits have been addressed.
Evaluate the internal audit program.
Verify that regulatory filings are up to date.
Conduct mock inspections.
Evaluate the Quality System.
Rule #4: Review and Verify All Data PRIOR to the Audit
If the inspection is known to be approaching, prepare a “war room” (i.e., a central location to store documents that may be relevant to the inspection). If the inspection is a “surprise” or short notice, use this section to anticipate the types of documentation that may be required during the audit. Many of these preparation steps are specific to PAIs; however, the principles apply for any type of audit.
Rule #5: Training and Company Structure Should be Appropriate
Rule #6: General Compliance and Documentation Should be in Place
During an inspection, a company has to demonstrate, with documentation, that it has quality systems in place and they are in compliance with cGMPs. A few examples of the documentation that would support a company’s quality systems are as follows:
Next – Handling A FDA Inspection