Page 39 - QA and QC
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GMP Training – Quality Assurance and Quality Control by www.gmpsop.com
designed to assure that components, drug product containers, closures, in-
process materials, labeling, and drug products conform to appropriate standards
of identity, strength, quality, and purity.
International GMPs
Chapter 1
QUALITY CONTROL
1.3. Quality Control is that part of Good Manufacturing Practice which is
concerned with sampling, specifications and testing, and with the organization,
documentation and release procedures which ensure that the necessary and
relevant tests are actually carried out and that materials are not released for use,
nor products released for sale or supply, until their quality has been Judged to
be satisfactory.
Overview
QC is the part of QA that checks the quality of a batch after it has been
manufactured. QC verifies that ingredients and products meet written and
approved standards, often called "specifications".
The QC laboratory tests samples of raw materials and finished products. It is
critical to get accurate results from QC tests. Otherwise, defective batches may
be released and good batches may be rejected.
The role of the QC laboratory then, is to detect any possible defects once they
have occurred, rather than prevent them from occurring in the first GMP Rules
place. The QC laboratory's specific responsibilities include: -
sampling, inspecting, and testing of starting materials and finished product
calculating and checking results against specifications
reporting all results and releasing on~ passed batches
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