A day in the life of a QP at MIAS Pharma

From the outside it may appear that a QPs role begins when the batch files are passed over for review, however this is the middle of the process.  Quality is not something that can be verified from a batch file or QC test alone.  Quality is building a case that supports the release of a batch.  Foundational to that is the QMS.  A QP needs to have constant and up to date knowledge about the facility, process and regulatory submissions for the medicinal product.  The QP needs to actively engage with deviations as they occur as well as any changes or regulatory updates which are often approved months or years before batch certification.  At MIAS this is particularly true as many of our clients are entering the EU for the first time.  Its really difficult to know what you don’t know, and there are a lot of things to get right.  At MIAS QPs are often hired to not only to perform batch certification but to act as a guide providing the necessary expertise so the client can succeed in bringing the product to market.  Unlike a lot of standard release sites MIAS is in a continuous process of certifying new product launches.  This was one of the biggest changes for me.  Previously as an inhouse QP I would be involved in one or two product launches every few years. The vast majority of the my time would be spent on routine batch release.  Now I am very much part of the project management process ensuing that launch goes smoothly from an early stage.  It is gratifying being able avoid potential  pitfalls before they even become an issue.

A QP must be a jack of all trades, from engineering to microbiology, medicinal chemistry to pharmacology.  They need to have  a depth of knowledge in all areas and be familiar with the legislative framework, restrictions and obligations for each market they release into.  As innovation and new updates appear the QP is required to stay on top of these new developments.  This means devoting time to ongoing  study referred to as continued personal development.  What is great about being in a team in MIAS is that everyone is working on something interesting or different, such as bespoke ATMP treatments, radiopharmaceuticals or niche orphan drugs.  I joke that by my career end I will have released every single type of product.  But aside from my personal development it is fantastic to have a cross functional team that are experts in such a broad range of areas.  There is a well of knowledge for me to draw on whenever a particularly spicy obstacle needs to be overcome.

Batch certification is the activity that is most associated with a QP. It is task that seems childishly simple at first blush, release the good batches and reject the bad.  However, QPs are not paid for the easy decisions but for their work in the grey. A batch can pass QC tests but still be rejected and conversely a batch can fail QC tests and still be released.  Decisions need to be made often with incomplete information. Using what evidence is available a case must be built for the fate of the batch.  Either reject or release, the QP will be the one who needs to stand behind the decision and ground the decision in the GMP requirements.

Even with all this, batch certification is not the final step.  Batches in the market are required to be monitored.  This means the review and trending of complaints, adverse reactions and stability reports.  For new drugs the QP may also be obliged to submit   reports to the regulator based on agreed post marketing commitments.

Is short there is lots of work to do before and after batch release.  The process of batch release its self may require a QP to look beyond appearances and think of the broader implications .  However perhaps the hardest part is trying to explain concisely what your job is to your friends who don’t work in the industry.