We are here to help you define and implement commissioning, qualification, and validation strategies for your facilities.
Our Tailored Support
We offer an approach tailored to our clients’ projects and industries (human pharmaceuticals, veterinary pharmaceuticals, medical and hospital devices, etc.), supporting them from strategic decision-making through to the completion of testing:
Guidance documents: VMP, Commissioning Plan, Risk Analysis
Participation in URS and specifications
Regulatory design review
Traceability matrix and test plans
Management of FAT/SAT commissioning phases
Drafting and execution of QC/QI/QO/QP tests
Process, Cleaning, and Analytical Method Validation
Deviation Management / Evaluation of Change Requests
Maintenance of Qualified Status
Audit and Training
Our support from inception through to production
Process Equipment
Pharmaceutical fluids: PWP (Purified Water), WIP (Water for Injectables), PCA (Pharmaceutical Compressed Air), PS (Pure Steam), pure gases
Classified Rooms / HVAC
BSL (Biological Safety Laboratory), Laminar Flow Hood, Isolator
Cleaning and thermal processing: CIP/SIP, washing machines/booths, autoclaves
Packaging line
Control and monitoring systems
Regulations & Guidelines
GMP
GMP
GAMP and other ISPE guidelines
ASPEC