Elaborate preparations are necessary during an FDA inspection. Before the inspections, the units should conduct internal audits and analyze quality data - deviations, OOS, rejects etc. Management has to review all the processes and systems. Training to key staff, review of SOPs, following procedures and monitoring processes and analysis of complaints etc. are a must as part of the preparation.
Before the FDA team arrives, ensure necessary regulatory follow-ups are done. Discarding of warning letters may render all products unacceptable and finding of significant deficiencies can result in discontinuation of inspection and issuance of further warning letters. Findings like all systems are not compliant and follow-up could result in further enforcement action and freezing of products in pipeline.
Ideally, create a company statement on audit behavior, be honest with the team and cooperate with them. Train personnel to answer the question directly and concisely. Be careful not to volunteer information and if you are unsure of the answer, do not guess. The procedure for responding to FDA activities includes prompt supply of photographs, electronic data, entering controlled areas and sampling. Identify the inspection team members, and define their roles and responsibilities (including back-up) like receptionist, trained facilitators and employees, note takers and subject experts.
Identify the logistics of the inspection, especially Who?, What?and Where?
Develop a strategy to manage the inspection from acceptance of the FDA-482 (Notice of Inspection) to the inspection closeout.
During the inspection, ask for a scope of the audit, timeline, or agenda so that you can have key personnel available. Encourage a daily closeout discussion and have a clear understanding of issues. Attempt to address concerns and request the corrections appear clearly in the EIR. After FDA leaves each day, note takers should create a summary report for management review. Then prepare for the "next step" of the inspection, assure documents/items are ready and available. It is necessary to effectively control your documents, so that it is readily available on demand.
Monitor observations made by the team during the inspection and compare it with the observations listed on the FDA-483. During a FDA inspection, the management has to play a key role by meeting the investigators, periodically checking with investigators, facilitate any decisions, help and resolve conflicts concerning the application of company policies, review daily inspection memoranda, facilitate and participate in the close out meeting, review and assist in responding to the 483 etc.
At the end of inspection, accept the FDA-483 and check out whether all statements during inspection closeout are included in the EIR. This is the time to clarify any issues and identify any inaccuracies. Discuss them openly with the team, and promise a written response. The management should discuss the issues, communicate it, and should correct errors. Promise corrective actions and ensure the management is present and actively participating in the meetings. Also analyse, how many observations did you miss?
After the inspection, plan, discuss, and respond in writing to the FDA-483 and determine if a regulatory attorney or consultant should review the FDA-483 and the response before delivery. Assure that promises for corrective action can be reasonably met.
(Based on the speech byJoseph X. Phillips, Former USFDA official and Regulatory Affairs Advisor, ISPE made at the ISPE annual conference held recently in Mumbai)