Q
What kind of quality plan is required for FDA QSR?
820.20(d) Quality Planning - Each manufacturer shall establish a quality plan which defines the quality practices, resources, and activities relevent to devices that are designed and manufactured. The manfucturer shall establish how the requirements for quality will be met.
I have a book that states that the Quality Planning document is a general, high level document that desribes the manufacturer's plans for implementing its quality system in general, including a description of the plans to meet cGMP req's, structure and interrelationships among personnel, responsibilities, long and short term objectives. That sounds like our quality manual!
Can our Quality Manual satisfy the FDA Quality Planning Document?
:
Thanks for any light shed on this!
820.20(d) Quality Planning - Each manufacturer shall establish a quality plan which defines the quality practices, resources, and activities relevent to devices that are designed and manufactured. The manfucturer shall establish how the requirements for quality will be met.
I have a book that states that the Quality Planning document is a general, high level document that desribes the manufacturer's plans for implementing its quality system in general, including a description of the plans to meet cGMP req's, structure and interrelationships among personnel, responsibilities, long and short term objectives. That sounds like our quality manual!
Can our Quality Manual satisfy the FDA Quality Planning Document?
: Thanks for any light shed on this!