Page 24 - QA and QC

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

Release for supply or sale
A formal release for supply or sale is undertaken by QA only after finished
product testing has been satisfactorily completed.
Release procedures require QA to:

review all laboratory tests and batch manufacturing records

ensure that product is correctly formulated and that any process deviations

are explained

verify that yield and reconciliation calculations are accurate

verify that labelling and packaging is error-free

For a batch to be released to the consumer, simply passing all tests is not
enough. Quality must be built in al all stages of manufacture.

GOOD TO KNOW – REVIEWING PRODUCT FOR RELEASE

What should a good release for sale review process look for?

a valid batch number and expiry date

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