Quality Role in Maintenance Operations

1
Preventive Maintenance

• 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.

2
Preventive Maintenance
Reference

• 211.67 Equipment cleaning and maintenance
  (excerpt).
• 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
Preventive Maintenance
Reference
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
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
Preventive Maintenance
But, but, but . . .
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)!
6
Preventive Maintenance
But, but, but . . .
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)!
7
Preventive Maintenance
But, but, but . . .
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
Preventive Maintenance
But, but, but . . .
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!