Cell and Gene Therapy Manufacturing: Prepared for Your Next GMP Audit?

As growing numbers of academic institutions and start-ups embark on producing cell and gene therapies under Good Manufacturing Practice (GMP) requirements, more and more organizations are facing the prospect of regulatory audits.

Preparing for and receiving a GMP audit can often be a daunting process, even for the most accomplished and experienced teams. However, with the right planning and training in place, you can achieve the best possible outcome. In this blog, we look at three critical strategies for executing a successful GMP audit.

1.Don’t let your facility tour let your GMP audit down

One of the first things your auditor will want to do is tour the facility. In particular, they will want to follow the path of your product from the receipt of raw materials to shipment out of the door, via any equipment it’s stored in along the way.

Throughout their inspection, your auditor will be looking out for possible cross-contamination sites, assessing cleanliness and checking that equipment is clearly marked with ID numbers, maintenance tags and up-to-date safety stickers. Therefore, ensuring that everything is clean and properly labeled, and the contents of storage instruments are properly organized, is of utmost importance. Don’t forget your auditor is going to be asking questions, so make sure the individual giving the tour is a knowledgeable and senior colleague.

2. Documentation is critical to passing a GMP audit

Your auditor will want to be certain any storage instruments you use are fit for purpose, have been properly qualified and are maintained in a compliant state of operation. As such, they’ll typically ask to review the most recent documentation to ensure you have a robust maintenance and re-qualification plan in place. On top of that, they will most probably aim to review the available records of all maintenance and re-qualification activities conducted over the last year.

This means you must be ready to provide the requested documentation, including details of procedures and personnel training. Be sure to do this in a timely manner – presenting this quickly shows you have complete control of your business.

Thermo Fisher Scientific understands the importance of robust documentation for GMP-compliant cell and gene therapy workflows. Products in the Thermo Scientific Cell Therapy Systems (CTS) Series Laboratory Equipment range come with a factory acceptance test documentation package that serves as a hub for GMP documentation, facilitating audit-readiness with minimal effort. Thermo Fisher also offers a range of field compliance services to help laboratories working in the GMP environment achieve the installation qualification/operation qualification (IQ/OQ) validation they need for a successful audit.

3. Ensure your team have practiced how to answer audit questions

Once the auditor has reviewed your documents, they may want to have a discussion with a relevant member of your team. Being prepared for these questions is one of the most important steps in a successful audit, so it is vital you have in place a training program that teaches personnel how to answer questions expertly and confidently. After all, practice makes perfect!

It is important that the person leading the discussion with the auditor is comfortable referring questions to other experts on the team to ensure the right information is provided in a timely and confident manner. The significance of this skill and being able to smoothly transition conversations reinforce the need for audit training across different positions and specialties, so the team is fully prepared to answer an auditor’s questions in the best positioning for the facility.

Want more tips for a successful audit?

Watch this on-demand webinar to discover more expert tips and best practices to ensure your GMP audit results in the best possible outcome.

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