What is DQ and its importance? Understanding The purpose of design qualification DQ.
Any equipment used in pharmaceutical manufacturing, is developed and engineered with the intended objectives. The objectives behind the designing an equipment is clearly defined in the user requirement specification (URS). The specifications and requirements listed in URS are the tests which the equipment is required to comply with or pass, a document where approval for the design is provided by QA and all stake holders is called Design qualification DQ.
For a pharmaceutical manufacturing firm, it is required to define the best possible specifications of the equipment which will fulfill the requirements of the manufacturing process, quality of the equipment, life of the equipment, installation ease of installation, operation and consistency in yielding desired result.
Good quality designed equipment is the first step for quality by design concept, where a product is required to be designed to yield the good quality even in the worst conditions.
URS for DQ of an example:
Metal detector:
Metal detectors will have to consider the following items during designing of the equipment.
1. Accuracy and type of metal particles: it should be able to detect ferrous and nonferrous metal particles of particle size 0.1 micron and greater. Requirement, a manufacturer may come out with the least possible size range, like ferrous 0.1 micron, nonferrous 03 microns. Equipment designer and team which will qualify the equipment for the desired function has to do an assessment in a practical scenario about the chances of such particle generation, etc. And they implement screening activity for excipients used in the product.
2. Detectability and Sensitivity : Equipment should detect the mental particles of above mentioned size easily during normal production set up with the operating speed.
3. Should not give false positive and false negative results: Correction to be done by manufacturer of equipment to nullify the noise and falls signals.
4. Size of the equipment: should be easily mountable in the area available.
5. Speed of the equipment: 10000 tablets / minute ECT.
6. Material of construction: Transparent Fiber Glass, easily cleanable.
7. Easy of cleaning of equipment.
8. Compliance for 21 CFR part 11 computer system, guidelines, control panel, HMI, password protection, ECT.
9. Challenge test: Prove sample for all size metal sample for challenging and verification.
10. Rejection system.
11. Certificates of calibration ECT.
Above is the brief design requirement or user requirement specification of a metal detector in a pharmaceutical company.
Design qualification: After this Design requirement is given to equipment manufacturer, manufacturer will incorporate the detail requirements into design drawings of the equipment.
These are reviewed by the team of quality assurance, production and engineering and head of the company for commercials. After its review the design is approved thus design qualification is completed, and given to the manufacturer of the equipment for manufacturing of the equipment.
