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Case Study.

Implementation of EU GMP regulations for GMP analytical QC testing.

Analytical / bioanalytical quality control (QC) tests for medicinal products / biologics are a "manufacturing step" and require GMP certification. Expand the scope of analytical / bioanalytical testing to QC of drugs / biologics as a service for drug / biologics manufacturers. QMS certified according to GLP and ISO 17025, but EU GMP regulations cannot be met. Lack of adequate resources with required GMP knowledge as main problem in GMP implementation.
Insufficient prior and internal GMP knowledge necessitates re-creation and updating of existing quality documents to broaden the scope and adopt processes of existing standards to meet GMP compliance and ensure NCA inspection readiness.


  • Implementation of an overall GMP-compliant quality management system, processes and standards
  • Implementation of an adequate GMP-compliant device qualification process
  • Implementation of GMP-compliant method and process validations, efficiency measurements and control systems (in-process controls, IPCs)
  • Preparation of the documentation required by EUDRALEX Vol 4, such as the Site Master File (SMF, Part III).
  • Achieve EU GMP compliance and National Competent Authority (NCA) inspection readiness.
  • Establishment of a comprehensive communication control / communication loop leading to continuous improvements

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