Page 51 - Introduction QC
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GMP Training – Introduction to Quality Control (QC) by www.gmpsop.com
Summary
This module has introduced the basic concepts and requirements of
pharmaceutical quality control.
The pharmaceutical QC laboratory operates within o regulatory framework. its
day-to-day operations are governed and outlined in a quality manual, which,
among other things, will list all the SOPs necessary for the smooth running of
the laboratory.
As with any responsible workplace, the QC laboratory has certain solely and
housekeeping requirements by which personnel must abide. MSDSs are
instrumental for helping personnel work with chemicals. A very basic rule to
follow is if personnel are in doubt as to how to proceed, they should be
encouraged to ask a supervisor for assistance.
Maintaining documentation is pivotal for success, not only tor SOPs but also for
documents such as laboratory records and notebooks. GMP rules and common
sense govern how records should be completed (e.g. recording all calculations,
conducting second checks, never using whiteout or erasers). Documents and
records also provide available and traceable evidence to interested parties such
as regulators that the laboratory has conducted testing within a quality system
framework.
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