Page 52 - QA and QC
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GMP Training – Quality Assurance and Quality Control by www.gmpsop.com
Sampling
Sampling is the removal of are presentative portion of a lot to access the lot’s
composition and characteristics. The purpose of testing samples is to make some
inference about the lot from which the sample is drawn:
to determine the quality level
to detect a certain level of defects
to assess the level of heterogeneity
to identify mix-ups, mislabeling, or contamination
It is assumed or accepted when sampling that:
There is an agreed or implied inherent risk in any conclusions.
Defects are randomly distributed in the batch.
The production process is stable and continuous.
Sampling limitations
No matter how well or how often QC testing is conducted, there is always some
risk that defects were not detected in the lot.
This means that defective product could be released even though it passed all
the tests. If one wanted to be 100% sure that a batch does not contain any
defects, every unit would have to be tested. Since this is not practical, some risks
would have to be accepted.
Despite these limitations, GMP regulations require companies to routinely
conduct QC test. However, properly following GMP regulations and QA rules
during manufacture and packaging will help prevent defects from occurring in
the first place, which reduces the company's reliance on QC testing.
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