Interesting links & suggestions
Efficient Meeting Cadence
Brief explanation with picture: From Bottom right to top left, at a daily level, per functional area, a 15-minute meeting, shortly reflect on yesterday´s tasks […]
Quality Management Review
Quality Management Review – Benchmarking Quantitatively! The cost of quality is an essential theme for any corporation. Typically, when the cost of quality is pictured, […]
Is It Time To Stop Using Mean Kinetic Temperature (MKT) In Pharma Storage & Transport?
We have come a long way in condition monitoring and control in pharmaceutical storage and transport. Fifty years after John D. Hayes’ frequently cited article,1 I […]
Covid-19 – Stay Healthy, Stay safe!
Ponder: This picture is a photo from World War II. What we see is a soldier carrying a donkey. The soldier is not carrying the […]
Bio/Pharma Maintenance 4.0: How To Get Started.
Part 1 of this two-part series looked at the core aspects of Maintenance 4.0 and outlined a comprehensive maintenance process flow. In this second part, […]
Maintenance 4.0 – The Next Revolution In Bio/Pharma Manufacturing
Pharma 4.0 is an all-inclusive term for a broad range of technologies and approaches, including devices and connected sensors that make up Big Data, the […]
An Introduction To Centerlining For Biopharmaceutical Manufacturing
For many years, preventative maintenance has been part of routine work processes at most bio/pharmaceutical companies. The challenge in most cases is striking the right […]
GDP Extended – Also covering API
Quality requirements for medicines do not end after production and packaging. Medicines and APIs are often shipped over long distances and different climate zones and […]
How to read Regulatory Syntaxes
In this short note an explanation is provided how to read regulatory syntaxes. In your native language that may not be to difficult but when […]
Pharmaceutical Transport Validation — Where To Begin?
Contrary to what many people think, the last point of contact between patients and their healthcare providers or the distributors of medicines is not the […]