Live Online Training on March 15/16, 2022: An effective change control system is needed to maintain GMP compliance after changes in the manufacturing of active pharmaceutical ingredients or finished products – keyword EU GMP Guide Annex 15.
The GMP-compliant production started troublefree and on time for the planned go-live. The authorities immediately issued the manufacturing authorization for the new site.
February 3, 2022, Rheinfelden, Switzerland: gempex supports as a GMP expert in the topics "basics of cleaning validation" and "practical implementation of the requirements in API production".
Live Online Training, January 25/26, 2022: Drugs that have been contaminated by foreign particles in starting materials and active ingredients can put patients at risk. But what should be done when foreign particles cannot be technically avoided?
Having successfully completed ISO 22716 certification, edding has opened the first tattoo studio in Hamburg to work exclusively with the new and EU-compliant edding tattoo inks from V.D. Ledermann. The scope of this quality commitment is unique in the tattoo…
Live online conference on 16 and 17 November with Ralf Gengenbach. Presentation of the revised ECA Guide 2.0, which now includes feedback from regulatory authorities, the pharmaceutical industry and suppliers. Time-saving qualification and validation…
