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GMP Training – GMP for Warehouse by www.gmpsop.com
4.19. There should be written procedures and records for the receipt of each
delivery of each starting and primary and printed packaging material.
Chapter 5 Production
5.5. Incoming materials and finished products should be physically or
administratively quarantined immediately after receipt or processing, until they
have been released for use or distribution.
Finished products
5.58. Finished products should be held in quarantine until their final release
under conditions established by the manufacturer.
Overview
One of the most important aspects of GMP is to ensure that the right raw
materials are received and that the correct raw material batch is issued to
production to commence manufacture.
Mistakes in this activity can have significant consequences for patient safety, or
cause batches to be rejected. Therefore, the utmost care must be taken when
receiving, logging in, storing, and issuing of raw materials.
STEPS INVOLVED BETWEEN RAW MATERIAL RECEIPT AND ISSUE
Receiving:
GMP commences on receipt of the raw materials
from the supplier. Raw materials must be checked
that they are intact, have been provided according
to the paperwork, and that labels identifying name,
batch number, and expiry date ere present.
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