In November 2018 LabPromEngineering’s head of validation department Oleksandr Belinskyi was attended the hotel based courses, organized by Compliance and Validation Ltd. (UK). From 6 to 8 of November in Copenhagen there were HVAC systems in focus, from 20 to 22 of November in Amsterdam there was the pharmaceutical sterilization under discussion. The attendees were from whole the Europe, e.g. the representatives of Novo Nordisk, Merck, Fresenius etc. It was very useful to verify the skills and knowledge with the foreign colleagues, to discover some details concerning both studies performing and regulator’s requirements in different countries and from different authorities, just like MHRA, FDA etc.
The particular attention was given to the draft of Annex 1 GMP EU, that dedicated to the sterile product manufacturing. It much more in details describes the requirements and approaches than current edition, remove some misunderstanding.
For example, concerning airflow patterns velocity on grade A areas it is mentioned, that the height (level) of the measurements could be chosen by the regulated company – either under the filter’s face or at the working level – but in any case it must be documented and directly associated with airflow patterns visualization, proving that both mentioned parameters provide the product protection. Clean up (recovery) test should be determined but it’s no more guidance value. Continuous particles monitoring in a case of sterile powders is described separately, allowing to perform it before and after manufacturing steps (clause 9.20).
It was remarkable that among the lectors were the specialists with reach experience, including test performing. The joke from SME John Welbourn was very smart – he told that he’s engaged for validation from the 20 years old age, now he’s over 50 and he’s doing the same – it’s possible to say that he has “zero carrier progress” :) But it means that with him was possible to discuss the particular details concerning steam quality test, that is very seldom possible to discuss with anybody else. It’s a single example, because the dialog was present with all the lectors that is invaluable. The courses allowing communication between the colleagues from the different countries in order to understand in the same manner the regulator’s requirements, implementing them in reality.