Biomedical Engineering Reference
In-Depth Information
regulatory side, see Denise Queffelec and David Peterson
(2008):
Failure to follow established SOPs is one of the
most frequently cited violations in FDA 483s and
warning letters. The frequency of SOP-related
violations points to the need for all regulated
companies to review their SOPs, their methods for
distributing compliant SOP training curricula, their
methods of validating receipt and testing for
comprehension of the materials, and their
documentation of SOP training activities.
6. 21 CFR 10.115. As Steven Weil (2004) has put it:
A
predicate rule
is an FDA regulation such as Good
Laboratory Practice (GLP) or Current Good
Manufacturing Practice (cGMP). Predicate rules
mandate and defi ne: What records must be
maintained; The content of the records; Whether
signatures are required; How long records must be
maintained.
7. 21 CFR 211.100. Of course the changes may be
improvements, or the opposite (i.e., procedure “churn”).
8. This has been recognized by the International Conference
on Harmonization (ICH) (2008) in its call for a system
for implementing CAPAs resulting from the investigation
of a wide range of observations, including “complaints,
product rejections, non-conformances, recalls,
deviations, audits, regulatory inspections and fi ndings,
and trends from process performance and product
quality monitoring [. . .] throughout the product
life-cycle.”
