INCREASING DEMANDS ON PROCESS AND TECH TRANSFER ACCORDING 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 switch from an existing production site to a new production site or when a product that was previously produced on a trial scale is now to be produced on a larger scale for the market.

Often there are reasons to relocate an existing product to another location or to build up additional capacity. The most speak of "copying the existing plants and processes".

That sounds simple, but there's more. 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 in 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. 

Especially the transfer of processes and methods, in the qualification and validation pharmaceutical manufacturing, has been newly included.

Important points include:

• Qualification status of the previous permanent establishment
• Documentation of the process or data changes made
• Process robustness
• Process understanding
• Illumination of the risks that may arise from a transfer, for example cross-contamination risks, etc.
• Ultimately, this also has a major impact on process validation

Batches manufactured with modified processes are not included in a stability program.

For avoidance of contamination, equipment is changed frequently. These changes are evaluated too little or not at all and there is a recall. In addition, in the event of a change, data on new manufacturing processes are missing in order to confirm the corresponding, previous drug quality.

To this end, the FDA often requires a comprehensive, independent evaluation of the change management system. The review should cover the entire change management process. The Change Management Programme should also take into account, in particular, that changes may be included in the stability programme, that arrangements for qualification and validation activities are taken into account and that 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 to ensure successful technology transfer:

• Packaging line tests
• Stability Display Methods
• Cleaning validation
• Health and safety review

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 prevention/elimination of human error be described.

These are just a few of the many necessary things for further manufacturing purposes that need to be considered.

We are happy to advise and support you!