B
B Qualification & Validation
The ATP-CGPharm Group offers a broad range of qualification & validation services according to the newest international standards.
The company supports its clients in planning, coordination, supervising and execution of qualification & validation activities and in preparing the required documents.
B
DQ - FAT - SAT - IQ - OQ - PQ - Validation
B Our highly experienced engineers, pharmacists & technicians elaborate the following key GMP-compliant documents:
> Qualification & Validation procedures
> Qualification and Validation Master Plans
> User Requirement Specifications
> Risk analyses
> Traceability matrices
> Qualification & Validation plans and reports
> Deviation reports and action plans
> Qualification and Validation Master Reports
> Requalification & 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 & humidity controlled areas
– Storage areas
– Warehouses
– Stability chambers
– Incubators
– Refrigerators
– Freezers
> Utilities
– Purified water
– Water for injection
– Pure steam
– Compressed air
– Process gases
