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GMP Training – GMP for Warehouse by www.gmpsop.com
5.41. Particular attention should be paid to printed materials. They should be
stored in adequately secure conditions such as to exclude unauthorized access.
Cut labels and other loose printed materials should be stored and transported
in separate closed containers so as to avoid mix-ups. Packaging materials should
be issued for use only by authorized personnel following an approved and
documented procedure.
Chapter 3
Premises and equipment
3.18. Storage areas should be of sufficient capacity to allow orderly storage of
the various categories of materials and products: starting and packaging
materials, intermediate, bulk and finished products, products in quarantine,
released, rejected, returned or recalled.
Overview
Preventing contamination and mix-ups of materials and products are the main
focus of GMP in the warehouse.
Some general rules to prevent contamination and mix-ups are:
Materials must be purchased only from approved suppliers to written
specifications.
All incoming materials must be placed into quarantine.
Quarantined materials must be inspected and/or tested to verify their
suitability for use.
All materials must be labeled clearly to indicate their inspection and test
status.
Materials must be stored safely to protect from deterioration and damage.
Records must be maintained for all issued material in order to ensure
traceability.
GOOD TO KNOW - CONTAMINATION
Contamination refers to the presence of any foreign substance in a product.
It may be:
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