Good Distribution Practice (GDP) – can we do more?

Good Distribution Practice (GDP) – can we do more?

When good drugs turn bad and how Good Distribution Practice can help I’m currently involved in the implementation of the regulatory controls around medicinal cannabis in Australia and eventually, we will need to work out the good distribution practice for medicinal cannabis. The Australian Government’s drug regulator, the Therapeutic Goods Administration (TGA) and the Office…

PIC/S – New Draft Annex 1 – Part 7 of 8
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PIC/S – New Draft Annex 1 – Part 7 of 8

This chapter contains information which was previously covered under the headings “Clean Room and Clean Air Device Monitoring”, and also clauses 66-69 on Aseptic Process Simulation (APS) which was under the old heading “Processing”. In addition to the 21 clauses from 2007 that have been revised and reallocated to 22 new clauses, there are 27…