Page 25 - QA and QC
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GMP Training – Quality Assurance and Quality Control by www.gmpsop.com
the batch was formulated exactly as per the master formula
production is as per the master manufacturing and the finished product
meets specifications
yields and reconciliations are within limits
the correct labels and printed matter are applied
there are no unexplained changes, corrections, or alterations in the batch
records
environmental tests or controls are satisfactory
in-process checks were within expected tolerances
there were no deviations, or any deviations are fully investigated and
explained
The above activities are a combination of checking against specifications
(testing in quality) and examination of the process (building in quality). It is
not enough to just release product because it passes all tests since only a small
proportion of any batch is tested. QA must be assured that all units in the
batch would meet requirements if tested and they are safe for the consumer.
After the product is released for sale, the next product review is by the
customer or patient. Any problems here will result in customer complaints, or
even worse, a product recall.
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