Are your design change plans adequately established?

A company recently received this 483 observation:

….. Procedures for design change have not been adequately established.

 Specifically, the Design Change Procedure, Section 4.4, Design Change Planning, states that the purpose of Design Change Planning is to define a plan which will define changes to product requirements, assess the device safety and whether new or altered risks are generated, define the regulatory requirements, define verification, validation and transfer requirements and define supplier verification, validation and transfer. There was no design plan documentation for design change numbers …

For more observations pertaining to medical device manufacturers, see Issue 1038 available today.  It also has observations pertaining to manufacturing controls, laboratory controls and sterile manufacturers.

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GMP TRENDS is a publication for the pharmaceutical and medical device industries, trending observations made by FDA investigators during GMP inspections throughout the world.

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