Qualification and Validation

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Contact

Valicare GmbH

Eschborner Landstraße 130-132

D-60489 Frankfurt/Main

Phone: +49 (0) 69-7909 343

Fax: +49 (0) 69-7909 345

Content

1. Qualification

Valicare supports its clients in qualification projects concerning manufacturing and laboratory equipment as well as utilities and clean rooms.

A risk based approach to Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) are documented and executed according to detailed test descriptions, pre-defined acceptance criteria and described responsibilities. Reports including deviation report and change control complete the GMP compliant qualification documentation.

2. Validation

Valicare supports its clients in validation projects concerning manufacturing (Process Validation) and cleaning processes (Cleaning Validation) as well as analytical methods (Method Validation) and computer systems (Computer Systems Validation). Validation protocols with definition of test methods and acceptance criteria define the risk based approach to validation. Reports including deviation report and change control complete the GMP compliant validation documentation.

 

3. Risk analysis

Valicare prepares GMP risk assessment for its clients and organizes risk assessment workshops with focus on manufacturing equipment or processes. The preferred risk assessment method is the FMEA (Failure Mode and Effects Analysis), the results being used for systems improvement and scope definition of qualification and validation. Risk analysis is a fundamental prerequisite for GMP compliant approach to qualification and validation projects

4. GMP Consulting

Valicare supports its clients in GMP compliance projects by audits at the client’s site or at his suppliers, GAP analysis and GMP compliant documentation. Consulting is based on EU GMP as well as FDA c-GMP requirements as well as international requirements for medical devices.