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