Does the Quality Unit have a role in GMP Maintenance?

1. Does the Quality Unit have a role in GMP Maintenance (and Calibration, Engineering, etc.)? Sure does! See the following Pharmaceutical Technical Services www.PTSGMP.com Facility Compliance Consulting

5. Preventive Maintenance Thus The CFR considers maintenance, including instructions dealing with specific equipment maintenance activities as well as program administration instructions as PROCEDURES impacting safety, identity, strength, quality, or purity of the drug product . And The CFR requires all PROCEDURES impacting safety, identity, strength, quality, or purity of the drug product to be reviewed and approved by Quality Control. What here is not clear?

6. But what of a Computerized Maintenance Management System (Tasks and Frequencies)? The need for review and approval should NOT be diminished because it is typed into a CMMS rather than a word processor! Tasks and Frequencies are identified in BOTH. A PROCEDURE by another name would smell (as sweet)! Preventive Maintenance But, but, but . . .

7. But Maintenance Tasks and Frequencies are only “Work Instructions”! The term “Work Instruction” is NOT found in 21CFR 210 & 211. But the preceding reference from 21CFR 211.67 says there must be descriptions of methods and schedules (tasks and frequencies) in a PROCEDURE. Once again A PROCEDURE by another name would smell (as sweet)! Preventive Maintenance But, but, but . . .

8. Preventive Maintenance A Quality Unit review does not add value since they are not savvy regarding maintenance Quality Unit review is a requirement of the CFR. The QU is not expert on many of the procedures they approve, e.g. operating a granulator or a lyophilizer, calibrating a signal transducer. The QU review looks for compliance issues, not technical requirements! But, but, but . . .

9. Preventive Maintenance The Maintenance Department knows what and how to do, and will do the right things. For 2002, 17 of 30 Warning Letters included a Maintenance topic. In fact Maintenance was #5 of the Top Ten List of Warning Letter citations! But, but, but . . .