The Key to a Successful Inspection

Stock up on tea and coffee, it’s that time again. The inspectors are coming.

Minimise the chance of follow-up and repeat visits. The key to a successful inspection is preparation.

👉 Correct & up to date documents

Have inspections in mind the moment you receive the green light for a project.

Start those required documents, keep them up to date, store them in the correct places, and ensure they are accessible for the appropriate people.

Don’t waste yours or the inspector’s time trying to find documents during the inspection. Ensure all documents are up to date and accessible beforehand.

If your team creates delays, it could be seen as impeding the inspection.

👉 Design and implement effective quality management systems.

There’s no one-size-fits-all. What may have been sufficient for one project may not be for another. Successful QMS must be tailored and implemented specifically to meet individual products.

👉 Create clear and concise SOPs which are understood by all those involved.

👉 Conduct mock inspections.

👉 Be interview ready

Have locations, rooms, and interviewees organised.

Interviewee unavailable in person? Arrange resources required for effective remote calls.

Don’t just allocate senior management for interviews, include interviewees who have day to day involvement in the procedures and are familiar with the documentation so that questions can be answered fully and correctly.

If you don’t know an answer, don’t guess. Refer to a document, procedure or someone who will know the answer.

👉 Select an appropriate inspection host.

The host can be key to a smooth inspection. They should:
–         Be sufficiently senior
–         Have a thorough understanding of the organisation and processes
–         An excellent organiser
–         An excellent communicator
–         Be available throughout the inspection

👉 Stock up on tea and coffee

For more information and guidance on how to prepare for competent authority inspections, Contact the team.

To discover how we can help you in other areas of pharmaceutical product and medical device development head to our Home for more information.

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