News

Product-specific Certificate Required. What does that mean specifically? What needs to be done prior to finalization of the EU MDR?

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?

Logistics for Pharmaceuticals - Qualification of Transport Service Providers - Good Distribution Practices.

The distribution of COVID-19 vaccines - rarely, has there been a topic from the world of GDP that has received as much public attention as this!

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.