Wholesaling principles
October 14, 2010
THE National Coordinating
Committee on Therapeutic Goods
yesterday released a range of
amendments to the draft “Code of
Good Wholesaling Practice” taking
into account feedback received
from the industry during a
consultation period last year.
Major amendments include
changes to sections 4 (Stock
Handling and Stock Control) and
section 6 (Management of
Complaints, Return of Unused and/
or Damaged Goods, and Product
Recalls) so that handling of
damaged, returned and recalled
medicines is included in Section 6.
Section 7 (Management of
Records, Documentation and
Standard Operating Procedures)
now includes a provision that
documentation should be adequate
to achieve the required standard of
recording and control for
quarantined stock.
And Section 8 (Cold Chain
Medicines) now includes a principle
that the cold-chain should be
maintained according to the
sponsor’s recommended conditions
in regard to product integrity, as set
out on the TGA approved product
packaging.
The tga.gov.au update also
includes feedback on some
submissions relating to such areas
as batch tracking, education
programs, performance monitoring,
and “impact on small businesses/
pharmacies”.
Submissions made during the
consultation period are now
available on the TGA website, and
the final Code incorporating the
changes is set to become effective
on 01 April 2011.
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