Design Review


A Design Review (DR) is a systematic process used to review the design of facilities, utilities, and equipment against specifications. It is best to complete a Design Review early in a project so that design or specification issues can be brought to the forefront before changes become damaging to the project budget and timeline.
ASTM International (2013) recommends Design Reviews should ensure the following:

  1. Design satisfies product and process requirements
  2. Design appropriately addresses critical aspects of manufacturing systems
  3. Risks to product quality and patient safety have been identified
  4. Unacceptable risks are mitigated by design or other means

Evaluating the deliverable during the design review process allows customers to verify the design and identify issues before fully committing to proceeding with the proposed design. The DR may also allow you to determine if the user requirements and specifications are adequate to yield the desired outcome. Design reviews should also include corrective actions for any discrepancies found.
An example of the Design Review process is shown below:

Example Design Review Process

It is imperative that specifications and user requirements are clearly defined before the start of a Design Review.  Once it is clear what the user needs, a qualified supplier should be sought to fulfill that need, in some cases based on the users need a new supplier may need to be identified and qualified for future use.  After the supplier has been qualified, a quote is requested and the vendor either requests additional information or provides the user with a submittal. The submittal then enters the Design Review process and is evaluated against the user requirement.  There are three potential outcomes.

  • The vendor submittal (design solution) fully meets the end user needs and is accepted which leads to a purchase.
  • The vendor submittal (design solution) provides additional items the user deems necessary and a revision to the user requirement is made which leads to a purchase.
  • The vendor submittal (design solution) doesn’t fully meet the user requirement. This may result in:
    • Working with the vendor to identify alternate solutions that would meet the user requirement.
    • Selection of a new/different vendor who can provide a solution that meets the user requirements.
    • Alternately, elimination of the user requirement from this specific purchase. In these case the end user would be responsible for identifying an alternate solution to address the unmet user requirement.

Design reviews should be performed by subject matter experts and appropriately documented.  This documentation should include a final statement that declares the design acceptable.  The review of design is a cGMP requirement as described in USFDA (2011, p. 5):

The cGMP regulations require that manufacturing processes be designed and controlled to assure that in-process materials and the finished product meet predetermined quality requirements and do so consistently and reliably. Process validation is required, in both general and specific terms, by the cGMP regulations in parts 210 and 211. The foundation for process validation is provided in § 211.100(a), which states that “[t]here shall be written procedures for production and process control designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess…” (emphasis added). This regulation requires manufacturers to design a process, including operations and controls, which results in a product meeting these attributes.

Ultimately design review is an aid to the facility to ensure the equipment, systems, and ultimately the manufacturing process is appropriate for commercial manufacture of drug products.

References:

ASTM International. (2013). E2500-13: Standard guide for specification, design, and verification of pharmaceutical and biopharmaceutical manufacturing systems and equipment. West Conshohocken, PA: ASTM International.

USFDA. (2011). Guidance for Industry. Process Validation: General Principles and Practices. Rockville, MD, USA: Government Printing Office.