Each manufacturer shall establish and maintain procedures to ensure that the device design is correctly translated into production specifications.
!Attention points
* Learn about what the FDA considers [[Production Specifications]]
* Particular care should be taken when the product involves new and unproved manufacturing processes, or established processes which are new to the manufacturer.
** It may not be possible to determine the adequacy of full-scale manufacturing on the basis of successfully building prototypes or models in a laboratory and testing these prototypes or models.
* No design team can anticipate all factors bearing on the success of the design, but procedures for design transfer should address at least the following basic elements.
** First, the design and development procedures should include a qualitative assessment of the completeness and adequacy of the [[Production Specifications]]
** Second, the procedures should ensure that all documents and articles which constitute the production specifications are reviewed and approved.
** Third, the procedures should ensure that only approved specifications are used to manufacture production devices.

The first item in the preceding list may be addressed during design transfer. The second and third elements are among the basic principles of [[Document Control]] and [[Configuration Management]].
bag
fda_public
created
Sun, 22 Jul 2012 18:36:21 GMT
creator
dirkjan
modified
Sun, 22 Jul 2012 18:36:21 GMT
modifier
dirkjan
tags
CFR
CFR 21-820.30
Design Controls
FDA
Quality System Requirements
Section
creator
dirkjan