The golden rule of GMP audits – My path into a qualified GMP auditor

2022-08-04 12:54

If it is not documented, it is not done

One of the first things I learned in my pharmacy studies was that “if it is not documented, it is not done”. It has been more than a decade since that lesson, but the statement is still usable in my daily work as a GMP auditor.

Pharmacists are known as pedantic or even strict people, and I would also describe myself as a precise person. Having eye for detail is beneficial for an auditor, but when I started studying pharmacy, I did not think of quality management as a potential career path – probably did not even know that it was a possibility.

Attention to detail

Although audits may seem like digging unnecessary details, they are performed in order to ensure that medicinal products meet their specified requirements for product quality and patient safety. For me as a Medical Service Specialist, details are important not only when auditing but also in my day-to-day work: e.g., when checking that marketing material or a scientific presentation is compliant with the applicable codes, laws, and requirements.

Marketing compliance was the task that I originally started working with at Biocodex PhaMe at the end of 2020. However, since the beginning, I expressed interest in quality work and audits as well. I had already gathered experience in internal and external audits in my previous tasks, e.g., while working as a QA Specialist. Luckily, there was a need for another auditor at Biocodex PhaMe, so I started my qualification for GMP auditor in March 2021.

Audit there, audit here, audit everywhere

During the course of one year, I attended a total of ten GMP audits: remote and on-site audits, audits regarding products for clinical trials and for medicines with marketing authorization, audits for API manufacturers, sterile products, and primary packaging materials – the variability was huge. To prepare for the audits, I participated in auditor training and studied relevant guidelines, regulations, and certificates. I also read previous audit reports, quality agreements, deviation lists, and CAPA plans. But the most important lessons came from attending those ten audits. I started first by taking notes and then step-by-step becoming more part of the audit as a co-auditor accompanied by a qualified lead auditor.

“If it is not documented, it is not done” -rule also applies to audits. What evidence do you have that your employees are trained to work according to the change? How do you prove that the raw material sampling plan is scientifically sound? What justification do you have for environmental monitoring? These questions and lot, lot more were asked and reviewed from different documents during my qualification period.

From behind the screen to the manufacturing plant

Since COVID-19, pharma companies and authorities have accepted remote audits as an alternative for on-site audits. Even though you get to see more during on-site audits, those can be successfully replaced by well-organized remote audits. An online audit follows the same process as a regular face-to-face audit: reviewing all the relevant facilities, processes, personnel, and documentation through a pre-audit questionnaire and interviews.

For me, it was an easy start when I got to participate in my first audits via Teams. This also made it simple to audit places located anywhere in the world. It was interesting to get to see the manufacturing premises, review the documents, and talk with the personnel.

I guess that remote audits are here to stay alongside on-site audits. Thus, auditors will keep looking for “if it was documented” in-person as well as through a web-camera: reviewing that actions are performed in compliance with GMP guidelines and company protocols and reporting findings. I am looking forward to upcoming on-site and remote audits, as even though my qualification is now complete, I keep learning something new from every audit.


Would you like to learn more about auditing and become a qualified auditor yourself? We at Biocodex PhaMe offer auditor training where you can refine your skills with our qualified lead GxP auditors. We can do a training tailored for your needs or you can participate in our general auditing training. Contact us for more information.

If you would need PhaMe experts to perform an audit on your behalf, want us to do an internal audit, or would like to prepare for regulatory inspection contact us for more information.