Design Qualification (DQ) in Pharmaceuticals

Standard Operating Procedure of Design Qualification (DQ) in Pharmaceuticals is describe in this post.

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1. PURPOSE

This SOP describes a procedure to,

1.1 Ensure that the Instrument / Equipment / System purchased, is according to user specifications and the Manufacturers literature.

1.2 Document the information that the design of the Instrument / Equipment / System meets specifications.

2 SCOPE

Design Qualification is performed before the purchase of any Instrument / Equipment / System in Production, Warehouse (RM/PM, FG), Q.C and Maintenance departments. DQ starts with filling of User Requirements Specification Form.

3 RESPONSIBILITY

3.1 Head of Deptt. and Section Officer (user) prepares User Requirement Specification and DQ Protocol for Equipment / Instrument / System to be purchased.

3.2 The concerned Engineer (s) (if required) helps the Deptt. (user) in Design Qualification.

3.3 Executive Q.A Validation assists the concerned Deptt. in DQ and reviews the Design Qualification Protocol. 

3.4 Q.A Manager and Executive Director approve DQ Protocol.

3.5 Chief Executive Officer (CEO) authorizes the Purchase.

4. MATERIAL & EQUIPMENT

4.1 Instrument/ Equipment/ System to be Qualified.

5. PROCEDURE

5.1 Concerned Department (user) prepares its requirements for Instrument / Equipment / System to be purchased along with Concerned Engineer (if require) on the Page 1 of Design Qualification Protocol and sends this page to Q.A deptt. for approval.

5.2 Executive Q.A Validation gets its approval from Q.A Manager, after thorough review.

5.3 Q.A assigns Design Qualification (DQ) # to Instrument / Equipment / System from the Equipment Qualification Log Book and sends this page back to section. 

5.4 Head of Deptt. and Section Officer get its authorization from Executive Director.

5.5 Head of Deptt. and Section Officer are responsible to get quotations from different suppliers.

5.6 After receiving quotations from different suppliers a comparison is made on the Page 2-3 of Design   Qualification Protocol and the Instrument / Equipment / System meeting user (Deptt.) requirements is selected.

5.7 Information about model, supplier, manufacturer, origin, warranty, basic price, delivery, freight charges and any extra parts (if any) of the Instrument / Equipment/ System selected are recorded on Page 2 & 3 of Design Qualification Protocol.

5.8 Any deviation from user (Deptt.) requirements is noted and its justification for acceptance and impact on operation / function is explained in Deviation report Page 4 of Design Qualification Protocol.

5.9 A Design Qualification Report Page 5 of Design Qualification Protocol is prepared which includes.

5.9.1 Date study initiated and date study completed.

5.9.2 Major findings (main characteristics) regarding the Instrument / Equipment / System selected.

5.9.3 Any recommendation (suggested by supplier).

5.9.4 Brief description of deviation report, their reasons & impact.

5.9.5 Location of relevant information and documents.

5.9.6 Conclusions (includes that Instrument / Equipment / System selected qualifies the DQ study and Design Qualification is completed).

5.9.7 Validity of Design Qualification.

5.10 After DQ completion, whole Report is submitted to Q.A for review and approval.

5.11 After Q.A Manager approval of Design Qualification Protocol along with relevant documents, purchase of that Instrument / Equipment / System is approved by Executive Director and authorized by C.E.O.

5.12 DQ document approval date and relevant informations are entered in the Equipment Qualification Log Book by Executive Q.A Validation.

5.13 This DQ Protocol, along with relevant documents, is placed in the Instrument / Equipment / System Master file of that department in Q.A department.

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