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...
by Trefor Jones` | Dec 4, 2022 | Uncategorised
Blog #5 – November 2022 Welcome to the fifth of my memo’s on Technology Transfer. This month I am looking at the last section of a typical technology transfer project workflow. Depending on the exact circumstances these steps can be different or be performed in...
