Frequently Asked Questions on Regulatory Inspections

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 regulatory 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.

Q.How long should an inspection/audit take?

A. There is really no specific time frame defined for an audit. 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 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 being provided so they can refer to the specific document when responding to any observations associated with that documentation. Basically, the hosting site needs to have an accurate log, so they are able to recreate the audit activities after the inspector leaves. This is especially important when responding to the audit observation because it eliminates any questions about which document/information was discussed. Audits are fast paced, and anything that helps people remember what was discussed benefits the ability to understand and respond to any observations associated with the documentation that was reviewed.

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 technical document, they may ask to see a previous version of the document. If this document is stored off site, then it may take a day or two to retrieve it. This is acceptable as long as you inform the inspector why there is a delay in providing the requested information. Bottom line, all questions and documentation should be answered as soon as possible, and if there is a delay, it is important to be transparent with the 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 inspection ends. In some cases, the observation may be easily corrected, so it might be possible to have the corrective action in place before the conclusion of the inspection, and if the correction is acceptable to the inspector, it may actually help remove that observation from the final inspection report. Having said that, the best advice is to wait until the inspection is completed before you implement any corrective action so you can be sure the action is appropriate for the observation and you have had time to make sure related documentation and activities have also been updated in relation to the observation.

About the Authors

Steven J. Lynn is executive vice-president, Pharmaceuticals for Regulatory Compliance Associates, Inc., and Susan J. Schniepp is distinguished fellow for Regulatory Compliance Associates, Inc.

Article Details

Pharmaceutical Technology
Vol. 45, No. 2
February 2021
Page: 58

Citation

When referring to this article, please cite it as S. J. Lynn and S.J. Schniepp, “Frequently Asked Questions on Regulatory Inspections,” Pharmaceutical Technology 45 (2) 2021.