Page 44 - QA and QC

GMP Training – Quality Assurance and Quality Control by www.gmpsop.com

LABORATORY QC COMPLIANCE

Sampling of starting materials and finished products is
completely governed by GMP regulations. All sampling
procedures and plans must be documented.

SAMPLING
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 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
TESTING 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.

Each product has a specific set of specifications
registered with the government authorities. Starting
materials and finished products are required to be tested
LABORATORY
DOCUMENTAT to these specifications, and the results reported to QA
ION management if there is a problem.

Batches may not be released to the market if results do
not conform to the approved specifications.

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