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...
by Trefor Jones` | Sep 2, 2022 | Uncategorised
Blog 2 – September 2022 Technology Transfer – Regulations & Guidelines There are few if any “rules and regulations” issued by regulatory agencies such as the FDA or EMA. There are probably several reasons for this, but high on the list must be: Technology...
