INCREASING DEMANDS ON PROCESS AND TECH TRANSFER TO GMP, AS WELL AS THE STRONG INFLUENCE ON PROCESS VALIDATION
A process or technology transfer is what happens when a pharmaceutical company wants to move from an existing production site to a new production site or when a product that was previously manufactured on a trial scale is now to be produced on a larger scale for the market.
There are often reasons to relocate an existing product to another site or to build up additional capacity. Most people then speak of "copying existing systems and processes".
That sounds simple, but there is more to it than that. Many factors influence the manufacturing process. That's why quality must be at the forefront of a tech transfer. Critical properties of the product must be known and taken into account during a technology transfer.
Technology transfer in the pharmaceutical industry means more than copy and paste!
The EU GMP guidelines require, among other things, detailed documentation of transfers, transfer plans and reports.
The transfer of processes and methods has been newly incorporated into the qualification and validation of pharmaceutical production in particular.
Important points include
Batches that were manufactured with modified processes are not included in a stability program, for example.
Equipment is frequently changed to avoid contamination. These changes are evaluated too little or not at all with regard to the previously validated process and sometimes lead to a recall. Furthermore, in the event of a change, there is a lack of data on new manufacturing processes to confirm the corresponding, previous drug quality.
To this end, the FDA often requires a comprehensive, independent assessment of the change management system. The review should cover the entire change management process. The Change Management Programme takes particular account of the fact that changes may be included in the stability programme, arrangements for qualification and validation activities are taken into account and the effectiveness of changes is determined. In addition, the reliability of the production is to be evaluated.
There are 4 key positions that also need to be challenged in order to ensure successful technology transfer:
For this reason, the validation plan often requires that all improvements or changes to the device and equipment design and at the same time the avoidance/elimination of human error are described.
These are just a few of the many things that need to be taken into account for further production purposes.
We will be happy to advise you!
