WHAT ARE SOME OF THE KEY PRACTICES
THAT MUST BE FOLLOWED TO ASSURE
THAT GLYCERIN WILL MEET USP AND
FCC REQUIREMENTS?
Compliance with USP and FCC requirements means more
than meeting the specifications given in the USP and FCC
glycerin monographs as determined by analysis. It also means
strict compliance with FDA regulations, most particularly
with the procedures outlined in the current Good
Manufacturing Practices to assure plant and equipment
cleanliness and to avoid contamination during handling,
distribution or packaging. Plants, warehouses and clean
rooms, where repackaging is done, are subject to FDA
inspection. Complete record keeping is obligatory to ensure
that every shipment of product is traceable by lot number.
A Certificate of Analysis also accompanies every shipment of
USP and FCC glycerin.
Next: WHAT IS GOOD MANUFACTURING
PRACTICES?
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