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 …
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 current COVID-19 pandemic and the measures put in place to control it is having a big impact from both a personal and a business perspective. We, as an industry, need to adapt to …
What is the Medical Device Single Audit Program (MDSAP)?
The Medical Device Single Audit Program (MDSAP) was launched by the International Medical Device Regulators Forum (IMDRF) in 2014 as a pilot program, satisfying the requirements …
Quality Management System software providers have matured in recent years, with an increasing number entering the Pharmaceutical and Medical Device industries and marketing themselves as 21 CFR Part 11 and ISO 9001 compliant.
The fact …
Since 2006, PharmOut has been a leading provider of highly regarded and coveted Quality Management Systems (QMS) template packs. Purchasing is simple and facilitated through our online shop – a simple click here, pay …
What you need to know about PIC/S GMP Documentation Tips
The TGA’s announcement of its intention to adopt PIC/S GMP PE 009-13 as of 31 December 2017 means Australian GMP manufacturers need to review their …
Quality Management System Documents
A well-written document with a comprehensive and well designed Quality Management System (QMS) can be a manager’s best friend. They are our daily guidance and instructions for our staff, the ‘go-to’ …
1. Over 70% of world drugs are produced in PIC/S GMP facilities (member countries or companies)
With the US FDA joining PIC/S in 2011 and many other agencies in the queue, compliance with the PIC/S …
