THE TGA has released a new
guide titled ‘Technical Guidance on
the Interpretation of Manufacturing
Standards’.
Although not legally enforceable
the new document provides guidance
for the interpretation of the TGAs
‘PIC/S Guide to Good Manufacturing
Practice for Medicinal Products
2009’ in relation to on-going
stability testing for Listed
Complementary Medicines.
The document states that one
batch of a complementary (listed)
product of each group should be
placed on the on-going stability
program each year, and ongoing
stability testing should be
conducted in line with the
regulatory guidelines for the
countries of destination.
The guide also states that stability
testing should be conducted in real
time at the storage conditions
specified on the product label.
For details see www.tga.gov.au.The above article was sent to subscribers in Pharmacy Daily's issue from 08 Oct 10 To see the full newsletter, see the embedded issue below or CLICK HERE to download Pharmacy Daily from 08 Oct 10
IN WESTERN Australia, Michael’s Chemist Group has started stocking therapeutic Nicotine Vaping Products (NVPs), pursuant to the Federal Government’s new vaping laws (PD 25 Mar).
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