GMP Compliance
Commissioning & Qualification
IT Validation
GMP Routine Support

 

As a GMP expert with an international presence, gempex in addition to meeting the applicable quality standards also provides the required guarantee regarding all compliance matters. gempex enjoys the trust of its customers. That is because gempex understands situations and problems, makes informed and pragmatic recommendations and assists customers with implementation. 

gempex – GMP Consulting & Execution

Handling of Foreign Particles in APIs and Excipients

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? ...

GDP - be Ready for Anything: Vaccine and Drug Distribution along EU Regulations

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! ...

Change Control and GMP Compliance

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. ...