Validation Projects
- Client: European subsidiary of a Global Japanese Pharmaceutical Corporation
The Challenges
New or modernized equipment and production systems needed to be transitioned into regulated GxP operations. Comprehensive validation was required to achieve regulatory compliance and ensure smooth operations.
The Solution
We prepared complete validation documentation according to GxP guidelines – including validation plan, risk analysis, test plans, and reports. Together with the client, we developed a standardized approach for qualification (DQ, IQ, OQ, PQ), tailored to each system type and production process. Our experts conducted the necessary tests to qualify systems for GxP operation. All results were documented in close coordination with the quality units to ensure full compliance. At the end of the process, local quality managers approved the system for use – with a fully audit-proof validation report.
The Result
The systems were reliably and compliantly put into operation. Both internal and external audits were completed successfully and without findings. The high quality of documentation enabled a rapid go-live and increased trust in the new systems among quality organizations.
