Page 35 - QA and QC
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GMP Training – Quality Assurance and Quality Control by www.gmpsop.com
Some of the QA/GMP requirements for managing deviations include:
QA should review process deviations.
Planned batch deviations must be approved by QA.
Deviations during production must be recorded.
Batches must not be released until investigations are complete.
Reprocessing or reworking must be approved by QA.
Contamination control
One of the fundamental aims of GMP is to provide rules to prevent product
contamination from occurring, as contamination is almost impossible to detect
once it happens. Since many patients are already unwell, contamination may
make them more unwell.
Not all contaminants can be seen (e.g. bacterial contaminants), and so strict
controls are needed to prevent contamination. Personnel should record on the
batch records if they suspect contamination has occurred, as well as report it to
supervision.
These two ampoules are actually contaminated. However, you cannot see this
with the naked eye. It's Important to know that not all contamination in
medicinal products can be seen, and in many cases, cannot be detected in
laboratory testing.
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