News

Practical Suggestions – Part 3: Here we go – the implementation

- New technical publication from gempex

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5 points for a meaningful PQR/ APR - Process stability and product quality annually checked, verified and improved

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- New technical publication from gempex

- Qualification in the field of Pharma-GDP

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New expert contribution from gempex

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Expert lecture by gempex on 15 June 2020 at the 18th Swiss Cleanroom Community Event, Pratteln, Switzerland

 

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Practical Suggestions – Part 2: Planning is what counts

- New technical publication from gempex

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How do manufacturers of medical devices of classes I to III ensure the compliance of their products?

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The new EU Medical Device Regulation (EU Regulation 2017/745 - EU Medical Device Regulation) came into force on 25 May 2017. The transition period is scheduled to end on May 26, 2020 - now discussions are underway to extend this transition period by another...

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Improvement of the GMP processes and upkeep of the production license at the new location - renewing the operating approval by the cantonal pharmacist.

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