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 manufacturing considers Technology Transfer to be successful if there is documented evidence that the receiving Unit (RU) can routinely reproduce the transferred product, process or method against a predefined set of specifications as agreed with the Sending Unit (SU).
The key points here are “documented evidence” & “predefined set of specifications”.
Well, as is frequently stated, the key to successful technology transfer is “communication”. You would never set off on a journey without knowing where you were heading, and it’s the same for technology transfer, success criteria define the journey and its end point, moreover predefining and agreeing these criteria provides the communication for everyone to understand the common goal, and their part in achieving it.
Of course, defined success criteria also have other major benefits,
- Defines the required deliverables – what and by who.
- Defines responsibilities.
- Defines the point at which responsibility for the manufacturing moves from Technical Transfer to Manufacturing. This quite often is a commercial and legal milestone triggering legal responsibilities and payments. And here, documented evidence of acceptance criteria being met is key.
This last point is quite important in that many times I have seen technology transfer projects just drag on with no one actually knowing who was responsible for the product manufacture, completion of technology transfer becomes a moving target.
Sometimes defining the success / acceptance criteria is relatively straightforward, such as successful completion of all required PPQ batches, but may not be so easy to define if the technology transfer is from say research and development to clinical trials where the technology transfer is part of a continuing process.
If you don’t define the success criteria, how can you tell if the technology transfer has been successful?
The success criteria should be defined, documented, and approved and agreed by both sending and receiving sites at the start of the technology transfer project. More importantly, it should be clear and unambiguous – there should be no doubt about whether the success criteria has been achieved or not. The document should contain:
- Scope and objective
- Resources and budget
- Timeline and milestone dates
- Roles and responsibilities
- Key deliverables
For transfer to commercial operations the focus would be on the stages towards being ready for process validation, but other aspects of the technology transfer may also be considered, such as
- Initial risk assessment
- Knowledge Transfer
- Analytical TT
- Packing TT
- Design Transfer
- Cleaning Validation Plans for Process Validation.
Once the Technology Transfer is completed evidence that the transfer is successful (i.e., has achieved its acceptance criteria) can be documented in a summary technology transfer report which should summarise the scope of the transfer, the critical parameters as obtained in the SU and RU (preferably in a tabulated format) and the final conclusions of the transfer. Possible discrepancies should be listed and appropriate actions, where needed, taken to resolve them [Ref: WHO Technical Report Series, No. 961, 2011 Annex 7 WHO guidelines on transfer of technology in pharmaceutical manufacturing]