TBD GMP manufacturing
TBD photo archives. Chemists working on site in TBD laboratory.

Service overview

GMP Process Validation

GMP validation aims to confirm that every facet of the manufacturing process aligns with Good Manufacturing Practice (GMP) standards and specifications.

Typically, three validation batches are produced for generic APIs, while a single batch suffices for early-phase clinical material, all conforming to phase appropriate GMP guidelines. Required tasks within this process encompass supplier qualification, GMP-compliant release of raw and starting materials, intermediate product testing, equipment qualification, process validation report compilation, finalization of standard operating procedures (SOPs), product release analytics, elemental impurity assessments, cleaning validation, and sample packaging and transportation.

This validation process is crucial for ensuring the manufacturing of APIs that are reliable, consistent, and compliant with regulatory requirements.

GMP compliant since 2008

Six cGMP production areas

Have a project in mind? Let’s discuss!