PHARMACEUTICAL INDUSTRY
PROJECT MANAGEMENT for EQUIPMENT & CLEAN ROOM INSTALLATION
The manufacturing of pharmaceutical products has to be maintained at high standards to ensure the
strength of the active ingredients, quality and purity of the final products. These standards ensure safe
and effective products for patients. Minute changes in any of these factors can have serious
consequences for patients, therefore the controls and checks put in place need to be far more stringent
than, for example, the food industry.
Because of these high standards, any project application that has an impact on the manufacturing
process has to be managed to liaise with Quality Assurance (QA), Quality Control (including microbiology
lab), Manufacturing, Science, and Technology (MS&T), Production, and Health,
QUALIFICATION & VALIDATION
Qualification is the action of proving and documenting that equipment or ancillary systems are properly
installed, work correctly, and actually lead to expected results. Depending on the risk assessment
results, qualification process mainly includes fallowing steps:
- Qualification Plan
- Design Qualification
- Installation Qualification
- Operational Qualification
- Performance Qualification
- Qualification Report
Validation is a documented program that provides a high degree of assurance that a specific process,
method, or system will consistently produce a result meeting pre-determined acceptance criteria.
With specialist technical knowledge, we are ready to support our clients in the process of all
qualification & validation requirements on the existing or new equipment as well as design, design
review, selection and installation.
