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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, check the requirement specification on the purchase order (PO).

After check it properly, the engineering department, production, will prepare the design qualification, which includes driving, 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 remark to the users.

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

Checking of Design Qualification for verification:

If there is any variation in driving and specification user will raise deviation and send a copy to the manufacturer and keep one copy for user development for further verification after this manufacture looks at this and take preventive measures and correct the specification. After this manufacturer will send a copy to the user department for further 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 and manufacturer to prepare the design qualification. These design qualifications will be sent to the user for review and approval. DQ can be prepared by either user or manufacturer, but it should be reviewed and approved by the user as well as a machine manufacturer. So design qualification is commercial as well as a technical agreement between machine manufacturer and user.

Final check of 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 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 after completion of the manufacturing of the machine. Machine manufacture will start the reconstruction of the machine as per DQ, and then he will prepare the next document 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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