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Qualification / Validation

Qualification
For quality assurance of pharmaceutical products qualification is a key component. Measures to secure quality are required by national and international regulations throughout the whole lifespan of any facility. The V-Model of qualification offers a project management tool to structure and combine technical and regulatory project tasks.


Cost optimization through "integrated" facility qualification
Dohm Pharmaceutical Engineering performs qualifications as GxP-service for all phases of qualification (DQ, IQ, OQ and PQ) – either as a global package or on a modular basis according to your individual requirements. We focus especially on a close coordination of schedules with facility planning and construction. This enables DPhE to create a sound basis for efficient and low-cost project implementation.

Validation

Regulations also require validation of processes or systems. Validation provides documented proof that prior specified requirements and acceptance criteria will be met in operation and can be reproducibly fulfilled.


Effectively reaching the goal.
DPhE knows the requirements of the Life Science Industry and offers you a comprehensive service portfolio. Our specialists cover all disciplines of qualification as well as process- or cleaning-validation. If required we will create specification sheets, request offers and conduct the necessary negotiations with the suppliers. We supervise delivery, implementation and installation. Our staff will conduct measurements in the course of qualification, validation, servicing, maintenance, and calibration with our own equipment. For more information on validation and experimental design, please refer to the following links:

> Technical Report Nr. 3 (Dr. Stefan Schenderlein)