Service Detail
Qualification & Validation Services
Comprehensive qualification protocols and validation studies across facility utilities, processes, analytical methods, and IT systems.
Service Overview
Validation is at the core of pharmaceutical quality assurance. We assist companies in executing protocols, sampling plans, statistical evaluations, and final summary reports compliant with cGMP requirements.
Scope of Qualification & Validation
- Facility & Utility Qualification: HVAC system air velocity/pattern testing, pressure differentials, HEPA filter integrity, and Purified Water loop revalidation.
- Equipment Qualification: DQ, IQ, OQ, PQ protocol development and execution for solid dosage, liquid, ointment, and sterile processing equipment.
- Process Validation: Prospective, concurrent, and re-validation protocols and summary reports (PVP/PVR).
- Cleaning Validation: Cleaning validation protocol, worst-case product matrix selection, swab/rinse sampling, and MAC/residue limit calculation.
- Computer System Validation (CSV): Validation for ERP, LIMS, PLC-driven machinery, and computerized laboratory equipment per GAMP 5.
- Analytical Method Validation: Method validation protocols and execution according to ICH Q2(R1) guidelines.
Need Validation Execution Support?
Talk to our validation specialists to plan protocol execution or review existing reports.
Enquire About Validation Support