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GMP Training – Introduction to Quality Control (QC) by www.gmpsop.com
industry specific and compliance with this standard is not o regulatory
imperative.
A combination of GMP rules and ISO 17025 requirements provide a complete set
of requirements for a regulated pharmaceutical QC laboratory. However, in the
pharmaceutical industry generally laboratory are audited and licensed according
to the GMP rules themselves. ISO 17025 is more of an optional requirement.
ROLE OF THE LABORATORY
QC compliance encompasses many activities
that are documented in the GMP rules.
Sampling
Sampling of starting materials and finished
products is completely governed by GMP
regulations. All sampling procedures and plans
must be documented.
If wrong or insufficient samples are taken or a
poor sampling technique is used, any
subsequent testing may then give misleading
results. As a result, good product may be
rejected, or much worse, defective product may
be released.
Testing
Testing of samples in the laboratory is a
mandatory requirement under GMP regulations.
Its effectiveness, though, is limited because the
entire batch cannot be tested nor can the batch
be tested for all types of potential
contamination.
In fact, QC testing is limited to looking for
defects after they have occurred, so it is not a
QA prevention system but rather a defect
detection system.
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