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 …
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 …
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 …
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, …
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 …
The Office of Drug Control (ODC) has recently announced changes to the cost recovery arrangements for the Medicinal Cannabis Scheme as the result of amendments to the Narcotic Drugs (Licence Charges) Regulations 2016. The …
It’s probably apparent to most of us right now that disaster brings out both the best and the worst in humankind.
Healesville, VIC thanks essential workers. Credit: E. Redding
Take heart in the incredible acts …
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, …
Supply chains for pharmaceutical manufacturing and medical device production are becoming increasingly complex. Medications, from source to shelf, now involve numerous networks and cross the borders of many different countries around the globe. Serialisation …
In general, pharmaceutical manufacturing facilities (usually of Class 7 and 8) tend to occupy large areas and volumes (large isolated buildings), due to the nature of the operations (such as tall process equipment availability, …
