Preparing for an FDA Inspection in a Global Pharmaceutical Environment - FDA has created a dedicated cadre of foreign drug investigators and established permanent offices worldwide. - BioPharm


Preparing for an FDA Inspection in a Global Pharmaceutical Environment
FDA has created a dedicated cadre of foreign drug investigators and established permanent offices worldwide.

BioPharm International
pp. 24-26


The first step in preparing for an FDA inspection is implementing an SOP that will govern employee activity during the inspection. This should be done whether or not an FDA inspection is anticipated. The SOP should provide guidance on a number of issues, including: greeting the FDA investigator, duties of key individuals, conducting tours of the facility, responding to FDA questions and requests for documents, employee documentation of the inspection, and inspection-closeout procedures.

When FDA schedules the inspection, obtain as much information as possible. FDA's foreign inspections are announced in advance, and are generally scheduled for a predetermined period of time. So when FDA schedules the inspection, obtain as much information from the agency as possible. The more that is known about a planned FDA inspection, the better. Specifically, determine the reason for the inspection (e.g., cGMP, preapproval, followup, or for-cause), when the inspection will start, how long the inspection will last, whom from FDA will be attending, and whether there are any special requests or documents to have ready. As soon as notification of the FDA inspection is received, alert the company's regulatory affairs, quality, and legal departments.


Once the dates of an FDA inspection have been established, make certain all crucial employees will be available during the inspection. Carefully select an inspection team that will be tasked with interacting with the FDA investigator. Part of this exercise is knowing who is crucial; knowing who is currently responsible and who was historically responsible; and ensuring that employees understand their responsibilities. One of the worst things that can happen during an FDA inspection is having an unqualified or unprepared employee answering vital questions posed by the investigator.


Prior to the inspection, review all the relevant and recent FDA Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) guidance documents and compliance policy guides, as well as the International Conference on Harmonization (ICH) Quality Guidelines. These documents are key to understanding FDA's often-evolving view of industry standards, which is as important to comply with as FDA's specific cGMP regulations. Additionally, it is helpful to analyze past Warning Letters and available Form FDA 483s; these documents offer valuable insight into what FDA investigators are keying on during inspections and what issues investigators deem to be worthy of a Form FDA 483 observation.


Ensure that all required documents are available for FDA inspection, and make sure they are organized, complete, and current. Reviewing key documents will allow employees to refresh their memory and understand the organization of documents. It is also advisable to have an English translation of critical SOPs and documents, if possible.


Bring any known deficiencies to light; especially any that may relate to prior Form FDA 483 observations or recurring issues. The goal is to avoid any surprises during the inspection, as well as taking any preemptive steps to correct or mitigate the deficiency prior to the FDA inspection.

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