1. Fundamentals of GMP Maintenance Ensuring a GMP Compliant Maintenance Program PQuality Preventive Maintenance Procedures are a requirement to properly qualify equipment Qualification of equipment is approved by Quality Unit Changes to PM procedures need to be approved by the Quality Unit to ensure maintenance of the Validated state. Preventive Maintenance

2. Fundamentals of GMP Maintenance Ensuring a GMP Compliant Maintenance Program PQuality Preventive Maintenance §211.67 Equipment cleaning and maintenance (excerpt). (a)Equipment and utensils shall be cleaned, maintained, and sanitized at appropriate intervals to prevent malfunctions or contamination that would alter the safety, identity, strength, quality, or purity of the drug product beyond the official or other established requirements. (b) Written procedures shall be established and followed for cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing, or holding of a drug product. These procedures shall include, but are not necessarily limited to, the following: (1) Assignment of responsibility for cleaning and maintaining equipment; (2) Maintenance and cleaning schedules, including, where appropriate, sanitizing schedules; (3) A description in sufficient detail of the methods, equipment, and materials used in cleaning and maintenance operations, and the methods of disassembling and reassembling equipment as necessary to assure proper cleaning and maintenance;

3. Fundamentals of GMP Maintenance Ensuring a GMP Compliant Maintenance Program PQuality Preventive Maintenance AND §211.22 Responsibilities of quality control unit. (c) The quality control unit shall have the responsibility for approving or rejecting all procedures or specifications impacting on the identity, strength, quality, and purity of the drug product.

4. Fundamentals of GMP Maintenance Ensuring a GMP Compliant Maintenance Program PQuality 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?

5. Fundamentals of GMP Maintenance Ensuring a GMP Compliant Maintenance Program PQuality 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

6. Fundamentals of GMP Maintenance Ensuring a GMP Compliant Maintenance Program PQuality 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

7. Fundamentals of GMP Maintenance Ensuring a GMP Compliant Maintenance Program PQuality 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!

8. Fundamentals of GMP Maintenance Ensuring a GMP Compliant Maintenance Program PQuality 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!