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

Root Cause Analysis and GMP - Fundamentals and Overview

Root Cause Analysis in GMP quality management systems --- Focus on the human error --- GMP expertise from gempex in a training ...

Validation of Excel Spreadsheets to Enhance Resources: IT Validation, Documentation, Compliance Testing, and Data Integrity

With the Excel applications now GxP-compliant validated, Axolabs fully meets the regulatory requirements for data integrity and compliance. Complex analytical evaluations can be prepared in a standardized manner, performed under controlled conditions, and ...

Milestone in China’s HP-API Landscape - NMPA Inspection for Licensing of a New Active Ingredient Successfully Passed

GMP requirements in accordance with Chinese, European und American Standards have been met --- facilty for high-potent API ...