Proper implementation of qualification and validation activities requires an established management system to guide a project or an operation plant to meet the regulatory requirements of the target regulatory market. The system consists of multiple documents:validation management, facility equipment qualification, laboratory equipment qualification, process qualification, cleaning qualification, etc.
A good design of the validation system allows flexibility and comprehensive to fit diverse projects, products, stages, markets, equipment facilities and systems, which provide cost-effectively solutions. We often see that in many companies, an over regulated and tight system missed a risk-based approach at the beginning, leads projects under serious difficulties for proceeding.
gempex experts take full account of the customer's products and market requirements and integrate years of project practical experience into an optimized qualification and validation management system, which covers the overall validation strategy and execution process and can assist in the implementation of necessary qualification and validation activities matching the risk levels.
Experienced in various validation projects
Covering Multi-field products (chemical drugs, biological drugs, raw materials and package, medical devices, etc.)
Technical consultants with years of experience in the quality department of pharmaceutical companies.
