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

Qualification and Validation

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

B   If you perform your Qualification & 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).

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