B Qualification and Validation

The ATP-CGPharm Group offers a broad range of qualification and validation services according to the newest international standards.
The company supports its clients in planning, coordination, supervising and execution of qualification and validation activities and in preparing the required documents.


DQ - FAT - SAT - IQ - OQ - PQ - Validation

B   Our highly experienced engineers, pharmacists & technicians elaborate the following key GMP-compliant documents:

> Qualification and Validation procedures
> Qualification and Validation Master Plans
> User Requirement Specifications
> Risk analyses
> Traceability matrices
> Qualification and Validation plans and reports
> Deviation reports and action plans
> Qualification and Validation Master Reports
> Requalification and Revalidation procedures
> …

B   ATP-CGPharm Group has more than 20 years of experience in Validation activities:

> Cleaning Validation
> Process Validation
> Computer System Validation
> Validation of analytical methods
> Validation of disinfecting agents

B   ATP-CGPharm Group has more than 20 years of experience in the Qualification of:

> Cleanrooms
> HVAC systems
> Process equipment
> Laboratory equipment
> Temperature and humidity controlled areas
     – Storage areas
     – Warehouses
     – Stability chambers
     – Incubators
     – Refrigerators
     – Freezers
> Utilities
     – Purified water
     – Water for injection
     – Pure steam
     – Compressed air
     – Process gases

Qualification and Validation

B   After completion of Qualification and Validation we can also define and perform the Routine Monitoring activities.

B   If you perform your Qualification and Validation activities with internal resources, ATP-CGPharm Group can also support your team through its consulting activities or by Furnishing of Qualified Staff (Staff Leasing).