Importance of the Design Qualification
- Documented proof that the proposed design of the installations, systems and plants is suitable for the intended purpose. (Aide Memoire GMP, inspection of qualification and validation in pharmaceutical production and quality control).
- Documented verification that the design proposed for installations, plants and equipment is appropriate for the intended purpose. (EC-GMP Guidelines, Annex 15)
Prior to the design qualification, it is customary to create a comprehensive risk analysis of the project, in order to identify risks before the design and to take these into account in the design stage by means of the appropriate weighting. This ensures a high level of process safety, as well as eliminating possible sources of error or complications (as far as possible) in advance.
Within the scope of the DQ, the following steps are to be carried out:
- Creation of a DQ plan
- Description of procedure
- Work instructions
- Create requirement specifications / invitation to tender
- Integration of risk analysis
- Obtain authorisations from the customer
- Comparison of requirement specifications (customer) with the approved requirement specifications
- Comparison of the design documentation submitted
- Functional descriptions including control system with the requirements in the requirements specification
- Approval of implementation
SEEFRIED Verfahrenstechnik GmbH supports and assists you in the documentation of the DQ – Design Qualification (creation of requirement specification / invitation to tender).