Pharmadule Morimatsu AB, Sweden
Magnus Johnsson has 20 years experience in the pharmaceutical field and is currently Director Regulatory Affairs with Pharmadule Morimatsu. Mr Johnsson has a Master of Science in Materials engineering from the Royal Institute of Technology (KTH) in Stockholm and a University Certificate in Psychology from Stockholm University. Previously positions include: Scientific Administrator with the European Medicines Agency in London. Section Manager Regulatory Affairs at PRC Engineering; Vice President, Quality &Validation, Pharmadule AB Mr Jahnsson has trained and practiced as an operational- development coach and have given a number of lectures and courses world-wide on QA and GMP.
The new QWP Guideline for Process validation that came into force end-2013 is very similar to the latest FDA guidance. Additionally, the draft annex 15 (qualification and validation) to the EU GMP-guidelines also opens up the possibility to use Continued Process Verification (CPV) instead of traditional process validation. But what are the regulatory requirements that have to be met in order to utilize this option and what are the advantages? What does a company have to do to convert an existing product file into a file that supports CPV and finally what are the major steps that have to be taken in the validation planning to be able to run CPV in a production line? This presentation will answer the questions above in on a high level and drill deeper into the validation planning required.