GDP and Documentation

esignatures-GxP-environment

E-Signatures on Documents in a GxP Environment – 7 Misconceptions

Electronic signatures (E-signatures) are becoming more and more commonly used in today’s world. Before electronic signatures were recognized and accepted legally, documents had to be manually signed by each of the signatories, stored and filed in squeaky compactors (compactus …

Form-Use

Form Use – the right way to fill in a form

Following on from the previous blog Form Design – it’s all about the white space, comes the exciting part deux: Form Use – the right way to fill in a form.
There is a general misconception that data integrity failures …

form-design

Form Design – It’s all about the white space

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 …

GMP-documentation

GMP Documentation – Top Tips for Writing User-friendly GMP Documents

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 …

Pharmaceutical-Quality-Systems-pqs

Pharmaceutical Quality Systems (PQS) 101

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 …

cannabis conferences in Australia

Quality Cannabis Production | Workflow in Medicinal Cannabis Production

Well-designed cannabis production workflows can help business owners understand the benefits of efficient and secure operating procedures in Medicinal Cannabis cultivation and production/manufacturing.
When it comes to the production of pharmaceutical-grade cannabis products and extractions (medicinal marijuana products), errors are …

fake cannabis medications in australia

Counterfeit Medications | Global Statistics | Australia Risks

Counterfeit medicines — fake drugs and falsified medicines — are endangering lives.
How large is the problem of substandard medications and falsified pharmaceuticals? What are the global statistics of counterfeit medications entering countries across the globe?

And how many fake …

Medicinal Cannabis Quality Management System

Medical Cannabis Quality Management System Templates

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 there, and you will be …

ISO 13485 2016 is here… what now?

PIC/S GMP Documentation Tips

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 current document retention schedules and …

data integrity training course

Data Integrity Training Course GMP update

In December, I attended my absolute favourite GMP event of the year, the Medicines & Healthcare products Regulatory Agency (United Kingdom) (MHRA) GDP / GMP symposium in London, aside from having the opportunity to drop into our London office and …