After receiving from the supplier the final specifications that are corrected in accordance to the results of Risk Analysis (RA) and developed User Requirements Specification (URS), Design Qualification (DQ) can be conducted. In the course of Design Qualification (DQ) the implementation of GMP requirements in proposed design is checked. DQ is the last step which focuses on check of documentation only. After DQ is successfully completed, the order is placed and the equipment is manufactured. It is necessary to make possible efforts that all equipment modifications are performed at the stage of DQ. Any modifications to the equipment after its manufacturing has already started will lead to financial losses.
Very often RA and DQ steps are combined. Carefully conducted RA significantly simplifies DQ activities.
Pharma Group Baltic offers:
Assistance/support in development of DQ Protocols by the Clients specialists
Checking DQ Protocols developed by the Clients specialists
Development of DQ Protocols by Pharma Group Baltic specialists
Assistance/support in execution of DQ
Execution of DQ by Pharma Group Baltic specialists
Checking DQ Reports developed by the Clients specialists