Pharmaceutical commissioning, qualification and validation
We have adopted the risk-based approach to qualification, based on ISPE good practice guide and ICH Q9. We follow a scientific methodology and are focused on process and product understanding targeted towards suitability for intended use. Our services are tailored to your business, whatever your challenge.
C & Q/ Validation Master Plans
Technical expertise for error-less validation master plan well-suited to your specific C&Q needs to ensure quality without compromising efficiency
Comprehensive risk assessment to establish most-to-least critical ranking and prioritize risks followed by design of validation plan based on these.
Facility and Equipment Qualification
Complete life cycle documentation and/or review (URS/FRS/DS/DQ/IQ/OQ/PQ/reports) designed by our experts in compliance with industry and regulatory standards.
Traceability of all cGMP aspects of the URS using many-to-many relationship at various stages of the qualification lifecycle.
Strategic recommendations and support on process and system design for gap analysis, elimination of weak links and remediation.
Analytical Method Validation
Assert the quality, reliability and consistency of your analytical methods with all-encompassing validation programs.
FAT/SAT Protocol Review
Review vendor FAT/SAT protocols and develop reports, on-site or remotely, for strict adherence to requirements.
Computerized System Validation
Prospective and retrospective validation of enterprise systems as well as stand-alone plant and lab control systems in compliance to 21 CCFR Part 11, EU Annex 11 and GAMP V.
IQ /OQ/ PQ Protocol Generation/Review
Ensure that systems adhere to user requirements and manufacturer’s approved specification and the recommendations of supplier are considered during the IQ/OQ process.