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Design qualification

Published
Topics: Aseptic services

Design qualification is the first step in the process of qualification of pharmacy clean rooms.

This article forms part of a series
  1. Designing and building pharmacy aseptic clean rooms
    1. Planning a new build project
    2. Assembling a clean room design and build team
    3. Writing a business case for a clean room build
    4. Writing the User Requirement Specification
    5. Understanding clean room qualification
    6. Design qualification
    7. Installation qualification
    8. Operational qualification
    9. Performance qualification

Contents

  1. Purpose of design qualification
  2. Pre-requisites for DQ
    1. DQ protocol
    2. Appointing the right team
    3. Prerequisites
    4. Design review
  4. Undertaking the DQ process
  5. Next steps

Purpose of design qualification

Design Qualification (DQ) is a formal, documented process of reviewing a proposed design for a new (or modified) facility or piece of equipment. It verifies that the design meets the User Requirement Specification (URS) and the facility or equipment will be suitable for its intended purpose.

DQ is an overarching term that refers to the processes of:

  • design review (DR) between the commissioning and team and the principal contractor
  • formal mapping of all critical design requirements from the URS to the DQ protocol and recording compliance in an overarching DQ record

Prior to the formal commencement of DQ, the principal contractor appointed to build the aseptic suite will define their proposed design in a detailed series of documents and drawings to be reviewed during DQ. At the end of DQ, all parties sign to approve the finalised design.

Together, DR and DQ provide assurance that the design delivers all URS requirements, conforms with regulatory requirements, and mitigates potential risks.

Pre-requisites for DQ

Design Qualification (DQ) should follow a clear, structured process, and certain steps must be completed before it can begin. The overall approach to DQ is outlined in the Validation Master Plan (VMP) and the execution plan, which must be approved by the Quality team.

Before starting DQ it is vital that:

  • the User Requirement Specification (URS) and, where used, the Commissioning, Qualification and Validation execution plan are approved
  • the DQ protocol itself has been approved by the quality team
  • the right people have been identified to review and sign the DQ
  • all Design Reviews have been completed and any outstanding design issues have been resolved

DQ protocol

The DQ protocol is usually prepared by the contractor or by a contracted validation specialist, particularly for large projects. The user should review this thoroughly prior to commencing formal DQ, to check for any omissions or errors. A good DQ document should include:

  • a description of the DQ process in the protocol
  • names, roles and responsibilities
  • all critical design points of the approved URS
  • a formal decision as to whether the URS is met at each point
  • space to record evidence, references and comments
  • a documented mechanism for dealing with deviations and derogations where the design does not meet the URS
  • a space to record the final decision for acceptance or rejection of the design

Appointing the right team

The DQ process requires input from the majority of the commissioning team. Some members will be actively involved in detailed decision making, and others will be involved in the final approvals and design sign-off. The input of a third-party GMP specialist may be particularly useful at this stage. Depending on the size and complexity of the project, the team may include:

  • Project Manager
  • Production Manager
  • Head of Quality Assurance
  • Accountable Person (if Section 10 unit)
  • Chief Pharmacist
  • Finance representatives
  • Estates representatives
  • subject matter experts, for example, for fire, electrical, HVAC, building regulations, infection prevention and control

The specialist contractor will bring representatives from their team to support the iterative process of finalising the design.

Refer to the article about assembling a team (SPS page) for further guidance.

Prerequisites

Define and document the prerequisites within the protocol in advance.

Design review

After the principal contractor has finalised the designs, a period of collaborative design review begins. This will be commensurate with the scale and complexity of the project.

For straightforward, off the shelf equipment purchases, the activity may be limited to reviewing the supplier’s Functional Specification (FS) and confirming that it meets the requirements defined in the URS.

For bespoke equipment or cleanroom construction, the design review process is often more iterative and collaborative. It typically involves a series of design meetings with the supplier to develop, review, and agree the final design to ensure it aligns with the URS as closely as possible.

When assessing proposed designs, pay particular attention to how materials, personnel, and waste will move through the facility. It is also important to consider operational factors such as process visibility, storage needs, and changing room requirements, as these can significantly influence the final layout and functionality. Where integration with existing systems is needed, this should be assessed and confirmed during the design review stage.

Undertaking the DQ process

For a clean room project this will take some time and will require the involvement of a team of subject matter experts and stakeholders. This process is likely to be undertaken over several meetings. For smaller equipment projects the DQ may be much simpler and involve fewer people.

Each requirement of the URS should be assessed against the supplied design and a decision recorded in the DQ protocol as to whether it has been met, along with objective evidence.

A range of documentation may be submitted for review during this process. These could include:

  • room data sheets describing the fixtures, finishes and fittings together with mechanical and electrical requirements for each room in the project
  • detailed drawings of the proposed facility layout, individual room layouts, HVAC plant, services, electrical sockets and data points
  • functional specifications for individual pieces of equipment to be installed as part of the build. These may include isolators, facility monitoring systems and CCTV systems

If any requirement is not met in full this should trigger a documented assessment to determine:

  • criticality of the requirement
  • whether a suitable alternative is acceptable
  • if the gap can be rectified
  • whether this user requirement can be omitted or ‘derogated’

When this process is complete, a final decision as to the suitability of the design must be formally recorded and the DQ protocol approved by the agreed named representatives.

Next steps

Once DQ is signed off, the contractor or supplier will start the construction or manufacturing process.

Subsequent qualification steps may include Factory Acceptance Testing of key equipment before proceeding to Installation Qualification (IQ).