Once the Pharmaceutical Quality System (PQS) (as per ICHQ10: Pharmaceutical Quality System) is implemented, it must be ensured that it continues to be effective, and for this to happen there has to be a clear commitment from senior management …
‘Continuous Improvement’ or ‘Continual Improvement’ within a quality system can be described as a process of ongoing improvement of products, services or processes through incremental and/or breakthrough improvements. Within the Pharmaceutical Industry, it’s important that companies ask themselves how …
Industry support of overdose prevention
This is blog 8 of 10 Blogs in the overdose awareness and overdose prevention series.
What is GxP compliance? And how does GMP/GxP compliance help with overdose prevention efforts?
GMP and GxP are pharmaceutical-industry quality standards and …
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 …
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 …
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 …
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 …
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 the current way of working …
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 of the pilot program in …
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 is that QMS software providers …
