It is at the discretion of an inspector to request documents prior to, during, and after an inspection. A document request after an inspection may call for a surprise even if the closing meeting was uneventful.

On-site Vs Remote

For obvious reasons, remote inspections are expected to have more document requests prior to the inspection as compared to on-site inspections. However, it is difficult to predict if document requests will be more for either of them during the inspection days. Some inspectors are expected to be too demanding; it does not matter if the inspection is on-site or remote. But yes, document review during an on-site inspection may be more convenient.

Effectively managing the document requests

Many inspectors follow a definitive numbering system where continuity in numbering is maintained, e.g., 1-9 were pre-inspection requests and the first request on the day of the inspection will be numbered 10.

If there are multiple inspectors making requests at the same time, it might be overwhelming for the marketing authorization holder (MAH). Hence it will be a good idea to periodically reconcile with the inspectors and check by when they would require the document, i.e., end of business (EOB) day or prior to the closing meeting.

Timelines for document requests

The inspectors generally request the documents uploaded by EOB or before the Closing meeting. If lucky, then they would provide a few days more (2-3 calendar days after the inspection dates).

Document requests related to cross-functional stakeholders

At times, the document requests may be related to business continuity plans (BCP), labeling and artworks (Regulatory affairs), or even other departments. This may be challenging at times, and it may be worthwhile to request extended timelines for facilitating the documents.

The only drawback of the document review (or even request) after the inspection is the unpleasant surprise in the inspection report.