DQ (design qualification)

Dear all,
I dont know if this the right place to ask this but i want to know about DQ (design qualification) about the protocol and report of DQ.
can somebody help me?


Design Qualification can be explained in 4 ways:

[b][COLOR=“blue”]1.ISPE base line guide describes this as the review activity aiming to accomplish the confirmation of operation requirements and Regulatory expectations. This brings enhanced structural review of a project which is otherwise called Enhanced Design Review (EDR).

2.FDA: Adequate Design which is stated as in 21 CFR Part 11, refers to design with the statement of appropriateness.

3.EU: GMP compliance Demonstration as per EU clearly states Qualification of design activities.

4.ICH: Verification Suitability (ICH) as per Q7A guideline states “Intended purpose suitability” for a facility or a system or an equipment. ICH tells more logical sequence on validation process rather than how to do it.[/color][/b]

[b][COLOR=“purple”]Traditionally it is done as a sequence:

Checking the User Requirement Specifications (URS) with the Request for Purchase (RFP)

Checking the RFP with Detailed Design Specification (DDS) that is the Drawings, Blueprints, Lay outs Etc

Cross checking the DDS with Factory acceptance test.[/color][/b]

Unfortunately this is not clearly defined as such in the industry as it is a new concept and companies are still evolving in making some detailed documents on this aspect.


Very good discussion over the Design Qualification. Actually I am on a littile bit different opinion for concept of design qualification is a new one. As such this concept was defined in the guidelines & literatures. Companies were addressing the same somewhere in between the lines of IQ / OQ terms not separately as Design qualification document. I personally know about some organization which are having these well written design qualification doc. almost 15 Years back…but definetely in agrrement that majority of companies are now adopting & preparing with these doc to face the audits. Even the FDA has clearly mentioned in recent validation guideline over the same.

Definition of DQ is already well explained…anyways type of document may be different (i.e. Only Design qualification report document after veriifcation, Protocol -cum-report or protocol & report) with post approval but content for verification will remain same.

Happy Reading !