Page 4 - Packaging Controls
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GMP Training – Packaging Controls by www.gmpsop.com
International GMPs
Chapter 5 Production
Packaging materials (extract)
5.44 When setting up a program for the packaging operations, particular
attention should be given to minimizing the risk of cross-contamination, mixups
or substitutions. Different products should not be packaged in close proximity
unless there is physical segregation.
5.47 All products and packaging materials to be used should be checked on
delivery to the packaging department for quantity, identity and conformity with
the Packaging Instructions.
Top reasons for drug recalls
Product recalls can cast hundreds of thousands of dollars can damage the brand
integrity of a supplier and harm the relationships between manufacturer
contract packager and retailer or end consumer.
Three of the top reasons for drug recalls are labelling issues.
Sub-potent (single-ingredient drugs)
Impurities / degradation products
Temperature abuse
Lock of assurance of sterility
Correctly labelled product in incorrect carton or package
Failed USP dissolution test requirements
Labelling illegible
Label mixup
Chemical contamination
Microbial contamination of non-sterile products
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