In recent years, TailorMinds has been a frequent guest at the training location of the Biotech Training Facility in Leiden. Our consultants Peter and Bas attended the training ‘Basics in Biopharmaceutical Manufacturing’ last week. We come here more often, not only to train our consultants. But also for network or knowledge events that we periodically organise for relations and professionals. This time with thanks to Ciriel Bhikhie as trainer/host and Ronald Kompier for the consultancy masterclass on vaccines.
The pharmaceutical industry
At TailorMinds, we find it important that our consultants are up to date with the developments in the pharmaceutical industry. This makes us a full-fledged discussion partner for professionals and relations. So: “How does a pharmaceutical production process run”. “What does someone in QA, Validation or Process actually do? Not dry material from a book, but real experience. Because learning is best done by doing. All this from the angle of how the professional performs his function. And how this is done in outline form.
A tailor-made training course has been set up for Peter and Bas. Various subjects are covered, including the purpose of GMP and starting up a production process. The validation and qualification of equipment and working aseptically. Experiencing’ working in a cleanrooms A, B, C and D, with the corresponding change of clothes procedure. Obviously with the aim of not causing any contamination.
Theoretically, knowledge was gained about writing a protocol, qualification principles, CIP, SIP and column chromatography. The subjects sterile filtration and pharmaceutical microbiology were also discussed. Finally, the backgrounds of producing API’s, UPS/DS and liquid/vaccine processes were covered. Finally, aseptic filling, the batch review process, product certification and release were discussed and performed in the cleanrooms.
Visit cleanrooms A, B, C and D
Theory was alternated with practical experience. By seeing, hearing, feeling and smelling, we were introduced to many aspects of the pharmaceutical industry. After seeing the HVAC, the SIP and CIP installations, Peter and Bas could go into the cleanrooms. There they experienced what actions and procedures are necessary to work in the pharmaceutical industry.
All these subjects were centred around Good Manufacturing Practice (GMP). Anyone entering the pharmaceutical industry comes into contact with GMP. Patient safety is always the starting point. This is why the backgrounds of GMP were explored from the point of view of regulations, legislation from the EU, US and ICH. And, of course, from the perspective of the pharmaceutical supply chain.
Are you interested?
Interested in talking to a professional at TailorMinds for roles as a consultant or professional? Check our vacancies page and maybe there is an interesting vacancy for you online. Do you have any questions? Feel free to contact us.