The TGA recently released their Notice of interim decisions to amend (or not amend) the current Poisons Standard, and those in the medicinal cannabis industry were waiting with bated breath for the decisions relating to low-dose CBD. Two proposals were submitted and have different results: Proposal Result Remove CBD from scheduled materials list altogether Rejected…
As a multidisciplinary Architectural & Engineering team, we get asked a lot of questions relating to the application of the National Construction Code (NCC) through the design phase of (pharmaceutical) facilities in Australia. A common question relates to the provision for escape. Pharmaceutical manufacturing facilities are generally considered to have a high fire hazard potential…
Tax. Return. Form. That sent a shiver down your spine, didn’t it? Because it’s longwinded, boring, complicated, sometimes unintelligible, and usually frustrating. Plus, there’s that added frisson from the fear of imprisonment due to unintentional tax fraud. Form design might seem like a banal topic but I’m pretty sure that we’ve all had first-hand experience…
In August 2016, PharmOut tendered and won a contract to assist a client to obtain a Therapeutic Goods Administration (TGA) Good Manufacturing Practice (GMP) Licence for a manufacturing facility, and in April 2017 they received their licence. This was not an unusual assignment as we routinely assist manufacturers with GMP licensing around the world. However,…
Good documentation (and well-written procedures) is key to achieving compliance with GMP requirements. GMP documentation should include enough ‘instructional detail’ to ensure that processes are well understood and user friendly, and should be ‘…designed, prepared, reviewed, and distributed with care’. (Clause 4.2, PIC/S Guide to GMP). The hidden costs of poor documentation are significant and…
Well-written documentation and a comprehensive and well-designed Pharmaceutical Quality System (PQS) can be a manager’s best friend. Pharmaceutical Quality System (PQS) documents: provide guidance and instructions for employees to complete the day-to-day activities are the ‘go-to’ during an audit or inspection are the first reference point when inducting new employees. But designing a good PQS…
It’s probably apparent to most of us right now that disaster brings out both the best and the worst in humankind. Take heart in the incredible acts of kindness reported daily as we recognise the sacrifices and risks that so many healthcare professionals, supermarket workers and delivery drivers are taking to keep the rest of…
Virtual Qualification, how can Pharma 4.0® thinking help during Covid-19 lockdown and what lessons can we apply to virtual qualification? The events of Covid-19 have opened up a new world of vulnerability to all industries, and especially those highly regulated like the medicinal products manufacturers and the possibility of Pharma 4.0® Virtual Qualification as a…
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