Page 38 - QA and QC
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GMP Training – Quality Assurance and Quality Control by www.gmpsop.com
solvent, and solvent agitation time. Often CIP
systems have alarms when something goes wrong.
The completed and signed records should be
attached to the records, since they provide the only
real evidence that cleaning has occurred.
QC testing is only designed to test for product attributes that are well-known
and understood. These attributes are part of the product specification. However,
laboratory testing cannot pick up all defects because the test may not exist, the
test may not be sensitive enough, or the test may not be required for that
product.
Companies therefore have to rely upon GMP rules and QA systems to prevent
these problems from occurring in the first place.
What do the GMP rules say?
US FDA CFR 211
Sec. 211.160 General requirements.
(a) The establishment of any specifications, standards, sampling plans, test
procedures, or other laboratory control mechanisms required by this subpart,
including any change in such specifications, standards, sampling plans, test
procedures, or other laboratory control mechanisms, shall be drafted by the
appropriate organizational unit and reviewed and approved by the quality control
unit.
(b) Laboratory controls shall include the establishment of scientifically sound
and appropriate specifications, standards, sampling plans, and test procedures
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