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Design Qualification in Pharmaceutical industry

A Design Qualification comes to the role after the User requirements specification is finalized. Once URS is finalized follow the given specification requirement on the purchase order (PO).

After checking it properly, the engineering, and production department will prepare the design qualification, which includes drawing, calculation, symbols, and other design documents. The manufacturer will study the design. If the design is ok, from the construction point of view, the manufacturer will put remarks on it.

Suppose the design is not compatible with the construction point and International standard point of view. The manufacturer will prepare a new drawing from the construction as well as a legal and user point of view. Then this drawing and specification will be sent to the user for approval. The user will amend /revise the DQ if possible.

Verification of Design Qualification

Verification is an important aspect to check that things are going as per predetermined criteria, If there is any variation in drawing and specification user will raise deviation and send a copy to the manufacturer and keep one copy for user development for further verification. Later manufacturer looks at this and takes preventive measures and corrects the specification. the further manufacturer will send a copy to the user department for checking. Suppose users found all the parameters ok. Then the manufacturer will start the construction of Machines according to specifications and requirements.

Design Qualification

Sometimes the user provides the User Requirement Specification to the machine manufacturer to prepare the design qualification. Later manufacturer sends it to users for review and approval. DQ can be prepared by either user or the manufacturer, but finally, it should be reviewed and approved by the user as well as the machine manufacturer. So design qualification is commercial as well as a technical agreement between the machine manufacturer and user.

Final check for Design qualification

After the finalization of the design qualification, the construction of the machine will start. During the construction of the machine, a user should visit the manufacturer’s site in order to check whether the construction of the machine is going as per design or specification. If any deviation from DQ or any mistake will be identified online, then it will avoid the loss of time and money before the end of construction. The machine manufacturer will start the reconstruction of the machine as per DQ, and then he start to prepare FAT( factory acceptance test).

DQ Protocol contents:

  • General
  • Document approval
  • Version control
  • Abbreviation
  • Objective
  • Responsibility
  • URS
  • Equipment Description
  • Technical design specifications of a machine, equipment
  • Functional design specifications
  • Technical specifications of Components use
  • Cabling or power details
  • Utility requirements details
  • Identification of Components for calibration test
  • MOC and finish of all components
  • P and I drawing/other drawing/calculation
  • Critical control parameters
  • Safety features
  • Change control and deviation procedure
  • DQ review and approval
  • Appendix
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