by Trefor Jones` | Jun 6, 2023 | Uncategorised
Tech Transfer Blog #10 – Engineering runs – Just an expensive Insurance policy? An Engineering Run can be also called many other names such as an engineering trial run, engineering lot or practice runs or demonstration runs but they are usually non-GMP runs...
by Trefor Jones` | May 1, 2023 | Uncategorised
What do I mean by the “Success Criteria” – often call acceptance criteria – for technology transfer, and why do you need it? The WHO Technical Report Series, No. 961, 2011 Annex 7 WHO guidelines on transfer of technology in pharmaceutical...
by Trefor Jones` | Apr 5, 2023 | Uncategorised
Documentation is a keystone of Technology transfer so in this memo I thought I would have a quick look at some of the baseline documents that would be needed from both the sending and receiving sides. I believe that the FDA once said that “if it isn’t documented then...
by Trefor Jones` | Mar 2, 2023 | Uncategorised
The recently published (August 2022) EU GMP volume 4 Annex 1 introduces several changes. In particular there is an increased requirement for the use of risk assessment and risk management methodologies. These are probably one of the most mis-used and mis-understood...
by Trefor Jones` | Dec 31, 2022 | Uncategorised
PAR: – Proven Acceptable Range DSp: – Design Space. NOR: – Normal Operating Range In reviewing technology transfer documents, I often see process...
