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GMP Training – Introduction to Quality Control (QC) by www.gmpsop.com
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. The requirements in this subpart shall be followed and shall be
documented at the time of performance. Any deviation from the written
specifications, standards, sampling plans, test procedures or other laboratory
control mechanisms shall be recorded and justified.
International GMPs
Chapter 6 Quality Control
6.15 Analytical methods should be validated. All testing operations described in
the marketing authorization should be carried out according to the approved
methods.
Overview
Test methods and specifications are at the heart of any well-run laboratory.
Well-written test methods drive good analytical techniques, effective training,
analyst competency, method validations, and minimize laboratory errors. Well-
written specifications provide unambiguous acceptance criteria for each test,
and demonstrate that test results are in compliance with product registration
details and pharmacopoeial monographs.
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