GreenvilleIndustries / Training

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PEV #5

Open GreenvilleIndustries opened 1 month ago

GreenvilleIndustries commented 1 month ago

FDA guidance: CFR 21 part 117.4 Equipment and utensils CFR 21 part 117.8 Processes and controls

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=117

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=117.40

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=117.80

For process equipment validation:

IQ, installation qualification: write a qualification referencing equipment manufacturer specifications. Goal is to ensure that the site meets the needs of the equipment. Usually executed by quality engineering as a commissioning activity.

OQ, operational qualification: write a qualification referencing equipment manufacturer specifications. Goal is to ensure that the equipment can perform its functions (self test, calibrate, normal operating behavior, etc). Usually executed by quality engineering as a commissioning activity.

PQ Performance qualification: write a qualification that test that test the equipment's ability to produce intended product under typical conditions. Goal is to ensure that the product produced meets specification when then equipment is run under typical conditions.

Routine verification: routine checks that product is within spec.