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...
by Trefor Jones` | Oct 31, 2022 | Uncategorised
Welcome to the fourth of my memo’s on Technology Transfer – Planning & Readiness. This month I am continuing my look at the workflow of a typical technology transfer project. As I said last month, depending on the exact circumstances these steps can be different...
by Trefor Jones` | Sep 29, 2022 | Uncategorised
Welcome to the third of my memo’s on Technology Transfer. This month I would like to start looking at the workflow of a typical technology transfer project, which assumes that the product will be outsourced to a CMO. Depending on the exact circumstances these steps...
