Qualification of pharmaceutical process plants
Testo Industrial Services took over the GMP compliant qualification of the process plants of the entire production area for Jäger GmbH and integrated the qualification documentation into a cross company qualification master plan.
As an innovative contract manufacturer, Jäger GmbH produces and packages products for well-known cosmetics and pharmaceutical companies. The production of several galenic forms such as liquids, lotions, gels, creams, ointments, powders is carried out strictly according to customer specifications with a manufacturing license according to § 13 AMG. A wide range of different packaging machines is available for packaging, which meet the highest quality requirements in compliance with GMP.
The aim of this project was to integrate the existing qualification documents into a cross company qualification master plan and to qualify process plants of the entire production area (bulk production and packaging) in a retrospective project in conformity with GMP.
Your advantage: Our competence
- Conceptual design/consulting in the area of qualification/validation
- Conceptual design of all qualification measures
- Structuring of the qualification activities via the qualification master plan
- Time planning and resource management
- Risk-based qualification management
- Preparation and moderation of system specific risk analyses
- Preparation of all qualification documents (IQ/OQ/FRQ)
- Execution and documentation of all qualification tests (IQ/OQ)
- Calibration/calibration management
- Consulting in the field of maintenance and repair conception