Professional Documents
Culture Documents
S. STEWART
INTRODUCTION
This discussion of Effective GMP addresses key considerations in
the development of manual cleaning procedures, documents reflecting
these procedures, and their subsequent use in cleaning performance.
Manual cleaning procedures may comprise the entire method of cleaning manufacturing equipment, or may be performed in conjunction
with automated cleaning methods. For example, mixing tanks may be
cleaned by an automated clean-in-place (CIP) cleaning procedure while
associated equipment and parts are cleaned manually. Manual cleaning
procedures should be considered as equivalent to manufacturing procedures regarding overall strategy and approach. After development,
cleaning procedures are documented, validated, and then routinely
used throughout the product lifecycle by trained personnel.
KEY CONSIDERATIONS
The following are key considerations for development, documentation,
and performance of effective manual cleaning procedures:
Manual cleaning procedures must be carefully developed using
scientific and technical principles but should also be practical and logical. Development work provides the technical basis
for the cleaning procedures. Procedures must be developed with
consideration for validation and ongoing routine use in the manufacturing facility throughout the entire product lifecycle.
Technical aspects must be chosen considering the inherent
variability of manual cleaning procedures and must be robust
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EFFECTIVE GMP
Operators should know how to appropriately inspect cleaned equipment and should
be especially aware of the most difficult to
clean locations on equipment. The final step
in the cleaning procedure is the inspection of
the cleaned equipment. Operators should be
trained in the proper way to inspect equipment
with focus on high-risk sections of equipment.
Operators should be aware of factors that may
cause erroneous inspections, such as insufficient light and equipment wetness. All personnel including operators, verifiers, and quality unit personnel involved with equipment
inspection should have inspection training.
Operators must be adequately trained in performance of manual cleaning procedures and
that training should be documented, periodically challenged, and frequently monitored.
Training on cleaning procedures requires
actual performance under the supervision of
area experts. Training cannot be by read and
sign. Training should be challenged by testing
and periodic auditing by the quality unit.
Operators must clearly understand cleaning
processes and the potential ramifications of
inadequate cleaning. Operators who perform
cleaning must clearly understand the objective
of cleaning. They must know that inadequate
cleaning may cause harm, illness, or other
medical effects of the consumer as result of
cross-contamination. They must understand
the seriousness of cleaning and perform cleaning with this in mind.
Operators must have a comprehensive
knowledge and understanding of the specific details of cleaning procedure being
performed. Operators who perform cleaning
must clearly understand that cleaning must be
performed as a defined procedure, not something like washing dishes at home. Operators
must understand that cleaning must be explicitly performed in the order specified in the
cleaning procedure. There is no flexibility in
performance, and operators must understand
why there is no flexibility.
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