Wednesday, September 9, 2009

Guidance document on the management of design and process changes

To ensure that good quality assurance practices are used for the design of medical devices and that they are consistent with quality system requirements worldwide, the Food and Drug Administration revised the Current Good Manufacturing Practice (CGMP) requirements by incorporating them into the Quality System Regulation, 21 CFR Part 820. An important component of the revision is the addition of design controls.
Because design controls must apply to a wide variety of devices, the regulation does not prescribe the practices that must be used. Instead, it establishes a framework that manufacturers must use when developing and implementing design controls. The framework provides manufacturers with the flexibility needed to develop design controls that both comply with the regulation and are most appropriate for their own design and development processes.
This guidance is intended to assist manufacturers in understanding the intent of the regulation. Design controls are based upon quality assurance and engineering principles. This guidance complements the regulation by describing its intent from a technical perspective using practical terms and examples.
You can download the guidance here - Design Control Guidance For Medical Device Manufacturers

In the last GHTF STEERING COMMITTEE MEETING last October a discussion started regarding the potential need for a guidance document on the management of design and process changes . It was decided that there is no consolidated approach to how changes are assessed by the regulatory jurisdictions. Hence in coming days the user group 1 of the GHTF is assigned to create the guidance document.

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