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

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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

PLAN FOR ANSWERING INVESTIGATOR'S QUESTIONS

First and foremost, all employees need to be directed to be honest and to avoid any speculation. Of equal importance, be prepared to speak with one voice and avoid internal disagreements while in front of the FDA investigator at all costs. Also, employees should be instructed to ask for clarification if FDA's questions are not completely understood (e.g., be clear on what timeframe FDA's request for documents covers). This is important so that all questions and requests are fully addressed, while at the same time refraining from saying more than what is necessary. Employees should also understand that it is acceptable to take a reasonable amount of time in responding to the investigator's questions and requests; responses do not always have to be instantaneous.

CONDUCT A MOCK INSPECTION

Generally, the best way to prepare for an FDA inspection is to actually practice one. This can help pinpoint any weaknesses in procedures or inadequacies in records, and it prepares employees for the types of questions that will be asked by the FDA investigator. Another benefit of practicing an inspection is—by providing a dry run for employees—they will be more comfortable when the actual FDA inspection occurs. The mock inspection should be scheduled far enough in advance to afford time to implement any corrective actions which become needed as a result of the mock inspection.

HAVE A ROOM RESERVED FOR THE INVESTIGATOR

While a simple matter, always set aside a quiet and securable conference room or office for the FDA investigator to review documents and to conduct his or her business. Ideally, this room should be away from any high-traffic employee areas, as well as the manufacturing areas.

An FDA inspection is an important event and should not be taken lightly. This is particularly true for non-US facilities that manufacture biopharmaceuticals, pharmaceuticals, and APIs for US importation. In these cases, the legal standard for FDA to refuse the entry of drug products into the US is significantly lower than what is required for FDA to initiate a domestic enforcement action (i.e., a seizure or injunction). FDA can refuse admission of an imported drug product if the product merely appears to be violative.

One way a drug product can appear to be violative—and therefore be denied entry into the US—is if it was manufactured at a foreign establishment that had a poor FDA cGMP inspection. Therefore, taking the time to carefully prepare the items discussed above, in advance, can greatly reduce any tension and increase the likelihood of a positive FDA inspection.

James R. Johnson is an associate at Hogan Lovells US LLP, Washington, DC, tel: 202.637.5600,
.


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