DQ covers all aspects of the design and procurement of facility and equipment. It is intended to encompass all those activities that might take place in the design phase, detailed and development, including activities associated with procurement of equipment and checkout at the supplier’s works.
DQ is a verification that the design meets user requirements with a particular focus on those requirements that relate to GMP and product quality. The extent of DQ may depend on the contract arrangements.
Normally in Pharma and Biotech plants there are 3 steps involved in DQ.
Step One
First it is to cross check your User Requirement specifications with the Purchase Order (PO). In some places PO might be referred as Request for Purchase (RFP). RFP can be made by a vendor who is finalized to supply you such material meeting all the technical and financial terms. After you receive the RFP check with all requirements of equipment as per URS as per your specifications and tick them against vendor specifications. Look keenly that every section is properly matching. In this you must look technical specifications, traceability and also vendor’s acceptance to supply material based on the specifications that you mentioned. Properly read in-between the lines and final technical annexures too. (The Quality-Production and Engineering team will be selected in this committee).
Step Two
In the second step you have to verify all the Detailed Design Specifications that are submitted in the RFP by the vendor with your URS. This again boils down to traceability and also to drawings
of the equipment. In this phase if any deviations are there you must make deviations reports and resubmit to your vendor and document the same at your company. When a new RFP with revised technical specs and drawings are received you have to look those deviation reports and make necessary corrective actions by verifying them with the new document you receive from vendor. A proper numbering system must be followed for your deviation documents and corrective action documents.
Step Three
The last step is to cross check between the Detailed Design specifications with your FAT results. This is based on the deviation reports you created earlier and you have to summarize all results.
The corrective actions will be implemented at Site Acceptance Tests or during commissioning of equipment as per the convenience between vendor and purchaser.
Sample Design Qualification Report
DQ report should include, but not be limited to the following:
1.0 DOCUMENT DETAILS
2.0 REVISION HISTORY
3.0 TABLE OF CONTENTS
4.0 OBJECTIVE AND SCOPE (A detailed reason why it is performed and on what it is being
performed)
5.0 DESIGN QUALIFICATION PROCESS
a) URS SECTION: It includes the old and revised URS
b) ATTACHMENTS: Engineering drawings, Flow charts, Process charts, Minutes of earlier reviews and FAT reports
6.0 SYSTEM DESCRIPTION
7.0 DQ PRE-REQUISITES CHECK-LIST
8.0 DQ TESTING AND REVIEWS
9.0 SUMMARY OF DQ RESULTS : Better make this into tabular form and give each a column and result.
10.0 DEVIATION / CHANGE CONTROL RECORD
11.0 APPROVAL SECTION (DQ EXECUTION TEAM WITH SIGNATURES AND DATES OF EXECUTION)
12.0 CONCLUSIONS AND DESIGN QUALIFICATION STATUS Approval Section
13.0 GMP assessment section where the required notes and certificates will be covered regarding Engineering controls, Drawings, Heat sensitivities, Operating ranges and contact material certifications. A brief notes on the operator safety review must also be included in this.
14.0 ABBREVIATIONS AND DEFINITIONS
15.0 REFERENCES
16.0 APPENDICES
