Qualification
By means of a professional qualification and validation it is ensured that production plants and products correspond to the demanded high quality standards at any time. Security can be ensured by a qualification and a validation by drugs and other products only.
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Definition: During the qualification it concerns a "documented argumentation", which proves that a certain process supplies reproducibly a product, which corresponds to the before specified specifications and quality requirements. |
To accomplish a professional qualification (for example in the pharmaceutical industry) different guidelines of the FDA (U.S. Food & Drug Administration) and the EMEA (European Medicines Agency) must be kept (GMP requirements). So it is possible to recognize possible weak points, to evaluate risks correctly and to seek out and convert all existing optimization possibilities.
Through our long experience and outstanding skills in this area, we can qualify our systems in cooperation with the customers. We would drive through all stages of the qualification (from the design qualification up to the performance qualification). All necessary documents will become provided in accordance with the internationally valid current guidelines and all qualification and validation work will be documented. A first-class and complete documentation is indispensable, in order to be able to occupy in the context of an inspection under a GMP compliant review of systems and processes. Obviously we always keep the ever-increasing requirements of licensing and inspection authorities in the eye.
The following list shows a selection of laws and guidelines, which are used in our qualification projects:
- FDA: 21 CFR Part 11 Electronic Records; Electronic Signatures
- EU-GMP-Guideline with Annex 11 "Computerised Systems"
- German drug law, pharmaceutical industrial-decree
- PIC/S-Guidance: Good Practises for Computerised Systems in Regulated "GxP"-Environments
- ICH Q7A: Good Manufacturing Practise Guide for API
- GAMP5: Good Automated Manufacturing Practise Guide for Validation of Automated Systems in Pharmaceutical Manufacture
- Validation of Process Control Systems
A qualification is not only in the range of pharmaceutical industry a necessary practice, particularly the design qualification and the qualification plan which always can be made brings a substantial plus point. With the introduction of new systems or machines within quality relevant ranges a qualification process should be always accomplished in the sense of the TQM. The result is an avoidance of later additional costs, since it is guaranteed that a system, a machine or also a software satisfyingly function.
