Concept and implementation of Established Conditions (EC) and Product Lifecycle Management (PLCM) Document." -- New technical article from gempex -- New instruments of the ICH Q 12 guideline
Training course on cleaning validation in the field of GMP on 03.03.2021: gempex supports as GMP expert in the topics "basics of cleaning validation" and "practical implementation of the requirements in API production".
New technical contribution from gempex -- Creating or redesigning quality assurance systems in a targeted manner -- a condensed, practical guide: key points, regulatory bases and requirements, possibilities for measuring efficiency
Foreign particles in starting materials and active ingredients are an unwanted contaminant that can later be found in the drug itself. And this can endanger patients. But sometimes foreign particles cannot be technically avoided. And then?
In order to meet regulatory requirements even after changes in the manufacturing process of active ingredients or pharmaceutical and biotechnological products and thus to maintain the necessary GMP compliance, an effective change control system is required.
The transitional period for the new EU Medical Device Regulation (MDR) ends on 26th May. It will bring significant changes for medical device manufacturers launching their products on the European market.
Live Online Training "The GDP Audit" of the ECA Academy on 28 and 29 October 2020 with Dr. Martin Melzer, Principal Consultant at gempex, as main speaker.
This Internet presence uses cookies. I consent to the use of cookies. For further information and the possibility to raise an objection, please click on ourPrivacy Policy.
