Design qualification (DQ, EDR)

   Design Qualification (DQ) or Enhanced Design Review (EDR), is a term adopted in the ISPE manuals (www.ispe.org) for describing the process by which the technical projects for pharmaceutical plants, systems and equipment, are estimated. This process belongs to the category of Good Engineering Practice (GEP).

   EDR can be defined as:
“A documented analysis of the project, at an appropriate stage of the implementation, for reviewing if the operational and regulatory requirements are met."

  A structural analysis of the construction facilities, utilities and equipment does not apply to the requirements of FDA (Office of the Food and Drug Administration), however, in the ISPE it is considered as an appropriate way to prepare for the processes of Installation Qualification and Operational Qualification (IQ / OQ). It is obvious that all parts are interested in the fact that the problems of regulatory or technological nature would be identified through a rigorous, structured analytical process at the beginning of the project, but not at later stages, during the Installation Qualification (IQ) or the Operational Qualification (OQ), when correcting the detected inconsistencies can cause significant delays and costs.

  EDR can be used as a tool for assessing the design of structured objects, energy carriers and equipment. It must convince the supervisory authority that the design process was carried out under the control, and that an audit log was conducted, starting from the conceptual stage and ending with the contract design.

  As it usually happens, project documents are produced in a number of different places. EDR is designed to identify all elements of the project with formal indices, which are linked by a cross-reference "route map" with the archival documents of the project.

  EDR aims to determine the “dividing line” between the definition of the project and such crucial changes, which may require a complete revision of the control procedures.

  EDR must be registered in the validation master plan (VMP) stating the purpose and the process to be followed, the duties of the persons involved and the contact EDR has with the good engineering practice (GEP) and qualification procedures.

   REGULATORYPERSPECTIVES

  The Enhanced Design Review (EDR) is not required for compliance with production facilities regulated by the FDA. EDR does not appear in any legal publications, which contain a set of rules, regulations or instructions.

  Nevertheless, the high demand for modern design is reflected in the rules of cGMP and the FDA, especially in this one:

  US Code of Federal Regulations (CFR), Title 21 Part 211, Subpart C - Buildings and Subpart D - Equipment. These chapters do a special emphasis on such definitions as "appropriate" project, "adequate" size, "suitable" design or location for cleaning, maintaining and proper functioning of the facilities, communications and equipment.