In today's world of always looking for ways to get something done faster there appears to be one area where speed has begun to do some harm. This area happens to be related to production equivalence. Quite simply, production equivalence is the evidence that a manufacturer provides to convey that the product has been created per provided requirements and under appropriate controls (i.e. process validation).

Where the hang-up seems to arise is when documenting Design V&V results. Design V&V requires the use of "production units, lots, or batches, or their equivalents. " (see 21 CFR Part 820.30(g)). What appears to be occurring relates to a disconnect between the manufacturer (internal or outsourced) and the team tasked with testing. Without having the production equivalence information the testing cannot be considered formal Design V&V. The simplest and likely the most user-friendly place to record this information would be within the individual Design V&V test procedures/reports. This is a requirement that should not require an overhaul to your QMS. With minor updates to forms or templates to require this information, QA should be equipped to ensure compliance to this requirement.

For more information regarding the requirement of production equivalence see the two paragraphs listed below. For the full websites associated with the paragraphs refer to the links to the specific FDA webpages.


From 21 CFR Part 820: 820.30(g)Design validation. Each manufacturer shall establish and maintain procedures for validating the device design. Design validation shall be performed under defined operating conditions on initial production units, lots, or batches, or their equivalents. Design validation shall ensure that devices conform to defined user needs and intended uses and shall include testing of production units under actual or simulated use conditions. Design validation shall include software validation and risk analysis, where appropriate. The results of the design validation, including identification of the design, method(s), the date, and the individual(s) performing the validation, shall be documented in the DHF. (


Determine if design validation was accomplished using initial production devices or their equivalents.

Initial production units, lots, or batches, or their equivalents are to be used in design validation. Confirm that such production devices or their equivalents were used by reviewing the design validation documentation. If production devices were not used, the firm must demonstrate equivalency to production devices. When the so called "equivalent" devices are used in design validation the manufacturer must document in detail how the device was manufactured, and how the manufacturing is similar and possibly different from initial production. Where there are differences, the manufacturer must justify why design validation results are valid for production units, lots or batches. The regulation is flexible and it does allow for the use of equivalent devices, but the burden is on the manufacturer to document that the units were indeed equivalent.

Process validation may be conducted concurrently with design validation. Production devices used in design validation may have been manufactured in a production run during process validation. (



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