by Trefor Jones` | Jun 3, 2024 | Uncategorised
I’m sometimes asked if a transferred process should use the same Critical Performance Parameters (CPP), Proven Acceptable Range (PAR) and Normal Operating Range (NOR) parameters and values and what parameter values should be used in the manufacturing documentation for...
by Trefor Jones` | May 8, 2024 | Uncategorised
Blog 12 – Technology Transfer of Clinical trial manufacturing. Firstly, what is Technology Transfer – I suppose putting simply it, includes everything that’s needed to move a technical process from one location to another. See my Blog #1 for more detailed...
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...
