by Trefor Jones` | Oct 12, 2023 | Uncategorised
The question of how many batches have to be run is a recuring question, not always easy to answer and there is a great temptation to just say three (3)! Although industry has typically used three batches during the process performance qualification (PPQ) phase to...
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...
