Raw Materials
Transferring a process to a new facility typically will require a different set of preferred vendors for raw materials. If
the raw materials have been registered, the sourcing of new raw materials must meet the registered specifications of the original
supplier. If the raw materials are not registered, a side-by-side assessment should be done to ensure comparable quality.
If comparable raw materials are not available, Design of Experiments with the new raw materials should be performed to assess
the impact on the process. Depending on the number of raw materials, this section may be incorporated into a separate document
to facilitate review and approval.
Conclusion
A process harmonization assessment (PHA) is a useful tool to compare various equipment sets proposed to manufacture a single
product. PHA compares the process flow, primary process parameters, equipment sets, and raw materials between the two sites
involved in technology transfer. Any technology transfer can benefit from the methodology of PHA. Node-to-node transfers benefit
the most from the high level of detail contained in a PHA document. Technology transfers in early development can benefit
from the documentation of the important parameters and initiate the development of these documents for future transfers. Technical
resources at both the sending site and receiving site are involved to enhance the communication and technical expertise of
both sites.
Andrew W. Rockabrand is an associate senior consultant engineer in Indianapolis API Engineering Servces at Eli Lilly and Co., Indianapolis, IN,
317.433.0545, rockabrand@lilly.com
|
