Qualification Phases

Using the concept already drafted, qualification takes place in a structured way in defined phases. In the interest of lean and thus cost-efficient qualification all activities are executed in close coordination with the development process, that is, the planning and execution.

Using synergies

In doing so, complying with “Good Engineering Practice” (GEP) principles plays a special role. Documents drafted within the scope of planning and execution are integrated into the qualification in a reasonable way.

Similarly, supplier qualifications can be integrated. In this case, Chemgineering pays attention to an adequate, contractually fixed definition of the specifications and ongoing support of supplier activities.

DQ to PQ from a single source

Chemgineering Technology Designers take over the project management of the entire qualification project. In this role we prepare the Master Qualification Plan (MQP), conduct documented GMP risk analyses, and align the qualification plans for the individual phases. In addition, we ensure that the qualification tests are conducted in accordance with the quality control plan.

You’ll get it in black and white

For compliant documentation, you as client will receive qualification reports and summaries for the FDA and other authorities. You can count on our support for inspections in particular. Training sessions for the operating personnel are also part of the program.

Trust our qualification experience. Contact the Technology Designers!

This will interest you too: Project Management | Qualification Concepts | Compliance Consulting

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