Biomedical Engineering Reference
In-Depth Information
Equipment cleaning and maintenance under
GLP, GMP, and medical device regulations
Table 11.1
Regulation
First Predicate Rule
Second Predicate Rule
21 CFR 58.63
(a) Equipment shall be
adequately inspected,
cleaned, and maintained
(c) Written records shall
be maintained of all
inspection,
maintenance, testing,
calibrating, and/or
standardizing
operations
21 CFR 211.67
(a) Equipment and
utensils shall be
cleaned, maintained,
and sanitized at
appropriate intervals to
prevent malfunctions or
contamination that
would alter the safety,
integrity, strength, purity,
and quality (SISPQ) of
the drug product beyond
the offi cial 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
21 CFR 211.182
Equipment and utensils
shall be cleaned,
maintained, and
sanitized at appropriate
intervals to prevent
malfunctions or
contamination that
would alter the safety,
integrity, strength, purity,
and quality (SISPQ) of
the drug product beyond
the offi cial or other
established
requirements
A written record of
major equipment
cleaning, maintenance
(except routine
maintenance such as
lubrication and
adjustments), and use
shall be included in
individual equipment
logs that show the
date, time, product,
and lot number of each
batch processed
