Batch release testing
Quality Control and Batch release service
Good Manufacturing Practice for Medicinal Products requires batch release within the European Community (EC) of medicinal products holding a marketing authorization.
We serve our partners with:
- Method transfer and Analytical exchange
- Batch release testing and analysis of various finished products to customers or pharmacopoeia release specifications
- On-site auditing of manufacturing facilities and GMP inspection prior to pre-approval agency inspection
- Comprehensive EU GMP audit report detailing the level of EU GMP compliance and suggesting actions to be implemented for compliance improvement
- Off-site auditing of Site Master File, Standards of Procedure, Validation Master File
- Qualified Person (QP) service on request