MIAS Pharma provides QP services for commercial and investigational medicinal products. Our QPs have experience in oversight and release of multiple types of products. Each type of product has it’s own specific properties and challenges, which determines what approach should be taken to provide the best solutions. Sterile products have to be free from viable microorganisms, practically free from visible particles and have established allowable limits for endotoxins. These requirements are essential for a patient’s safety.
A QP is responsible for this type of product needs to know different techniques of sterilisation like dry heat sterilisation, steam sterilisation, radiation sterilisation, EO sterilisation and aseptic techniques in addition to technics of solution preparation or lyophilization.
Radiopharmaceutical products have other challenges. They usually have very short shelf-lives. In practice, it means that at the time of dispensing the products to hospitals and patients, not all of the analytical results are available.
The release process, as per annex 3 of EU GMP, has to be conducted in two steps. The first one is a conditional release that is done by a QP before dispensing of a product based on manufacturing data and the limited number of analytical tests. The second step is a final release, and it takes place after dispensing when all test results are available.
A QP responsible for this type of product needs to be aware of special requirements related to radioactive products. These requirements are very often contraindicative to aseptic techniques. And because most of the radiopharmaceutical products are sterile products, a manufacturing process still needs to ensure that product meets requirements related to sterility, visible particles, and endotoxins.
The additional challenge related to these products is to have procedures which allow them to work effectively and in a timely manner as the release of products needs to happen in hours not days. Biological pharmaceutical products are another type of product that requires specific knowledge. A manufacturing process starts with the manufacturing of a drug substance. This process is very long and involves such processes as cell cultivation, different purification steps, and virus inactivation steps.
A final step of the manufacturing of a drug substance is often called formulation and involves adding excipients present in a finished drug product. Drug Products are usually sterile products in the form of a solution or lyophilized cake. So again, knowledge about sterile products is essential.
If you would like to get in touch with MIAS Pharma, please email firstname.lastname@example.org or call us on +353 (1) 846 3605.