Introduction:

MIA for Marketed Products: Importance of matching the correct QP to your product

As science advances the types of products on offer have grown in complexity. From Oral Solid Dosage Forms  (OSD) to novel Cell and Gene Therapy products, the range of technical knowledge required is vast. At the very end of the manufacturing and testing process sits the Qualified Person (QP). This person is responsible (per Annex 16 of the EU GMP Guide) for certifying the batch for release to market or clinical trial.

Whilst the QP may not necessarily know, or for that matter need to know the precise science that has gone into the product, what is critically important is that they have an underlying knowledge of how the product is manufactured, what are the critical process parameters (CPP’s), the Critical Quality Attributes (CQA’s) and be able to understand, when things go wrong, whether the action taken is appropriate.

Matching Process

Step one:

The first step is to request a copy of the CV from your potential QP. This CV should detail their education and qualifications, their background and should include some information on what product types they have worked on. Critically assessing the CV can help to narrow the pool of people under consideration.

When reviewing the CV, you should first consider background. Many people that qualify as a QP come from Quality, Manufacturing or Laboratory backgrounds. During this time, they will have been exposed to certain product types that can help to inform their understanding of the method of manufacture and testing. They will have seen things go wrong and learned from corrective actions, preventative actions, and continuous improvement initiatives. This experience can prove invaluable when confronted with a deviation, Out of Specification (OOS) investigation or risk assessment. In this situation, there is no substitute for experience.

Step two:

The second area to consider is training and development. QPs must maintain a continued professional development (CPD) programme to ensure that they remain current with developments in GxP. Many QPs will use their CPD to learn about product types that they may not yet be familiar with. For example, a QP who has a deep knowledge in OSD products may attend courses on sterile manufacturing. This will give them a good theoretical understanding of the manufacturing process.

Step three:

The third area to consider is the stage of manufacture for which you require the QP. Annex 16 provides for QP Confirmation wherein a sequence of QPs can independently review, approve, and take responsibility for a certain stage of manufacture. For example, QP A could approve the Bulk manufacture and QP B could approve the Packaging. It should be noted, however, that the final QP in the chain takes overall responsibility for all the previous steps.

As a guide a non-exhaustive list of product types in increasing complexity is included below:

OSD –> Topicals (Creams, Ointments etc) –>Sterile Injectables –> Biologics –> Vaccines

–>Radiopharmaceuticals –>ATMP

Conclusion:

Whilst the QP is the last step in the process for certifying the batch to market they rely on the experience, knowledge and diligence of many  teams involved in the entire supply chain and all the way through the manufacturing process. Although the QP may not be a subject matter expert on every aspect of the manufacture and testing of the product, it is critical that they understand what are the CPP’s and CQA’s and be able to make informed decisions if and when an issue arises.

At MIAS Pharma we have a number of QPs with a wide range of experience covering all product types. We have the expertise and knowledge to ensure that when your product goes to market that your patients’ needs are met.

Get more information about our QP services here.

For any questions get in touch with us at info@miaspharma.com