Process, Equipment &
Facility Validation
Our focus is on ensuring that new, modified, or expanded systems consistently deliver high-quality products while meeting global regulatory requirements, including cGMP, FDA, Health Canada, and EMA standards.
We ensure systems are properly designed, installed, and fully compliant through a structured Validation Master Plan (VMP), which defines project scope, responsibilities, and timelines.
Our process validation approach aligns with lifecycle principles, encompassing three stages.
Stage 1 – Process Design
Gathering development and analytical data, identifying critical quality attributes and critical process parameters, performing risk assessments, and defining acceptable operating ranges.
Stage 2 – Process Qualification (PPQ)
Confirming the suitability of the equipment and facility, and then running PPQ batches with defined parameters, sampling plans, and acceptance criteria.
Stage 3 – Continued Process Verification (CPV)
Routine monitoring of critical process parameters, critical quality attributes, and in-process controls, along with statistical analysis of batch data.