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GMP Training – Packaging Controls by www.gmpsop.com
Sec. 211.130 Packaging and labeling operations. (extract)
(d) Examination of packaging and labeling materials for suitability and
correctness before packaging operations, and documentation of such
examination in the batch production record.
International GMPs
Chapter 5 Product
Packaging operations (extract)
5.52 Checks should be made to ensure that any electronic code readers, label
counters or similar devices are operating correctly.
Overview
During the packaging and labelling operation, GMP rules specify a certain
number of necessary online (in-process) controls.
Online controls should include the fallowing checks:
the bulk material and printed matter
the appearance of the product (e.g., chipped labels, particles in sterile
injectable)
the equipment used (including the label verifier)
the count or measure of the filled container
the label appearance and adhesion coding
the tightness of the cap
the seal integrity or the packs
When these checks are done by production staff, the check should be audited by
the Quality Department.
Run Charts
Run charts are often used to monitor manufacturing processes. They show the:
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