Experts Steven J. Lynn, executive vice-president, Pharmaceuticals for Regulatory Compliance Associates, Inc., and Susan J. Schniepp, distinguished fellow for Regulatory Compliance Associates, Inc., provide simple answers to frequently asked questions regarding FDA inspections, although many of the concepts can be applied to internal and supplier audits as well.
Q. What documentation should I have ready to present to the inspectors?
A. There are a number of documents and supporting evidence that can be staged prior to an inspection whether it is in-person or is being handled remotely. The objective is to make the inspection process go smoothly for both parties.
At a minimum, there should be a list of all current standard operating procedures (SOPs) provided to the auditor so they can choose the specific ones they are interested in reviewing, a listing of customer complaints for the past two years, a list of current closed and open deviations and corrective and preventive actions (CAPAs) for the past two years and the site’s quality manual, the current organizational charts, a copy of the employee training program, and a map of the facility. In addition, it is advisable to have a short introductory presentation (5–10 minutes) that describes the facility, the products produced, and the operating hours of the facility. This information can be provided up front for the inspectors.
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Q. How long should an inspection/audit take?
A. There is really no specific time frame defined for an audit or regulatory inspections in general. Typically, supplier and internal audits should take between one to two days and a regulatory inspection typically takes three to four days.
Any inspection/audit can be extended depending on what the auditors/inspectors observe during the inspection. If things go well, the inspection will be completed quickly. If problems arise, the auditors may wish to extend the inspection and pursue the issue. This time frame is consistent whether the audit is done in-person or remotely.
Q. Do I need to make copies of everything the inspectors request?
A. In organizing for an inspection, it is advisable to track all audit documentation provided to the inspector. This is an important activity whether the inspection is performed in-person or remotely.
The inspection tends to run more smoothly when both parties are looking at and discussing the same documents. Whatever documentation is provided and kept by the inspector, it is advisable that the hosting site keep a record of the documentation. For instance, being able to provide specific data when responding to observations associated with that documentation.
Basically, the hosting site needs to have an accurate log to recreate the audit activities after the inspector leaves. This is especially important when responding to the audit observation. It eliminates any questions about which document/information was discussed. Audits are fast paced, and anything that increases data integrity helps people remember what was discussed. In addition, it helps the regulatory inspections team respond to observations associated with the documentation.
Q. How much time do I have to answer a question after the inspector asks it?
A. There really isn’t a defined time frame to answer the questions. Questions that can be answered immediately should be answered immediately. Questions that need a little more investigation or clarification before answering should be responded to in a timely manner.
Let’s look at an example. If the inspector is reviewing a manufacturing processes technical document, they may ask to see a previous version to compare the improvement. Your QA team should know if this document is stored off site or may take time to retrieve it.
The delay is acceptable as long as you inform the inspector why the time is needed to provide the requested information. Bottom line, all regulatory compliance documentation should be delivered as soon as possible. If there is a delay, it is important to be transparent with the FDA inspector and explain the reason for the delay.
Q. If an inspector makes an observation, do I need to have a corrective action in place before the inspection ends?
A. No, there is no reason to have a corrective action in place before the FDA inspection ends. In some cases, the observation may be easily corrected. It can be possible to have the corrective action in place before the conclusion of the inspection. If the correction is acceptable to the inspector, this can help remove that observation from the final inspection report.
On the other hand, the best advice is to wait until the FDA inspection is completed before you implement any corrective action. This way you can be sure the action is appropriate for the observation. The entire team can use the time to make sure related documentation and team communication has been mass produced.
Vol. 45, No. 2
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