In this blog article series on regulatory affairs inspections, we talked about the importance of making a good impression when the inspector or investigator arrives and how to do that. To prepare for the inspection – which can happen anytime – we talked about putting together a preparedness inspection management team. Also, we went over basic and advanced options for inspection management software to stay organized and expedite the inspection process. In the last inspection series installment, we initiated the discussion on who to have available during an inspection. In this blog, we’re taking it one step further and into the crux of the matter – fulfilling the inspector or investigator’s requests.
You’ve created a room for the inspector to do their work, the audit room. With the inspector are the host and at least one scribe. The scribe is writing down everything the inspector says, and these notes are relayed to the backroom. The backroom can contain several people, as many as needed to expedite the process.
The goal is to fulfill an inspector’s request in 15 minutes or less.
The three main request types are paper records, electronic records, and asking to speak to someone. Keep a record of all documents, files, drawings, etc., that are being provided.
Requests for paper documents or records are relatively simple –
- Make sure the document is complete and doesn’t have any yellow stickies on it.
- Figure out who is the best person to talk about the record, if so needed.
- Bring the document to whoever is going to present it to the inspector.
- Give it to the inspector, and then they will give it back when they’re done.
An electronic record request is similar in structure to the paper record, but simpler. These kinds of requests are fast and easy with inspection management software. The primary components for electronic record and document requests are:
- Review the electronic record or document in the backroom.
- Send it to the investigator.
The final type of request is a bit more involved. The regulatory affairs inspector or investigator might request to talk to someone in the company. For example, they might want to interview someone from quality control specializing in chemistry or microbiology. Have your Subject Matter Expert (SME) come into the room with the inspector. Then the SME will undergo a series of questioning as if they are on the stand in a courtroom. The SME should:
- Listen to the investigator and what they want carefully. Every time the investigator asks a question with two components, the SME should clarify first with, ‘which question do you want me to answer?’, and then wait for the answer.
- Answer the question as if in a court of law because this is, more or less, the same thing.
- Only respond with ‘yes’ or ‘no’ or the most concise and brief answer to the question – without elaborating or going off-topic.
- Then immediately discontinue speaking and wait patiently.
There’s nothing better than practice. Practice inspections, practice retrieving and presenting, practice showing documents virtually, have the SMEs practice by grilling them and giving feedback. PSC Biotech® provides experienced professionals to help you prepare for and practice inspections. Contact us for more information!
Remember – be polite, listen to the question, and think before responding.
We have several more tips for you in our subsequent installments of the inspection series – frequently asked questions, how to wrap up an inspection, and our recommendations for your receptionist’s red book. Follow our blog by email or social media for more insights from our former FDA inspectors, engineers, and exceptionally experienced professionals!
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