Transfer of technical information is necessary to realize manufacturing formula established
in the above in the actual production facility. In the past, the technology transfer
was mainly seen as standard transfer or as technology instruction from technology
department to production department within the same company. In principle, how accurately
transfer technical information (know-how) from transferring party to transferred party
is important, and it is essential to establish responsibility system and prepare documents.
When transfer technology of new products from research and development department
to production department, technical information to be transferred should be complied
as research and development report (development report and recommend to use the development
report as a part of technology transfer documentations). Production is implemented
after various validation studies verify that it is able to stably produce based on
transferred manufacturing formula. While the manufacturing facility accepting technology
is responsible for validation, the research and development department transferring
technology should take responsibility for validations such as
- Performance qualification (PQ), cleaning validation,
- Process validation (PV) unique to subject drugs.
- For validations such as installation qualification (IQ) and
- Operational qualification (OQ), which are not unique to the subject drugs,
it is possible to effectively use data of already implemented validations.
Furthermore, chemists can use their research skills and apply themselves at chemical
plants in making chem-based resources, such as rubber or synthetic oil. Chemistry
isn’t all about research, but rather being able to use chemistry towards making supplies,
materials, etc. for companies or large corporations. There are multiple paths for
chemists to choose from. When choosing a path do not limit your options, but rather
expand on them.
An understanding of the key processes involved in technology transfer is important
for chemists working in both academia and industry and there are now many examples
where effective technology transfer has led to major commercial success. The event
'What a chemist needs to know about technology transfer' introduced and explored the
concepts of technology transfer in the context of chemistry and the chemical-using
industries. It took place in the School of Chemistry, University of Nottingham on
Thursday, 9 July 2009.
“We see that 80% of chemists are to some extent dissatisfied with the direction they
feel they’re being pointed towards in their research”
~Tim Hector
4 Key Terms to ensure successful Technology Transfer
- Packaging line trials - if a product is a new SKU to the site, it is crucial to perform
line trials, filling the product into the proposed bottle or cap.
- Stability indicating methods should already be in place, enabling onsite transfer
against the protocol signed off by the client.
- Cleaning validation needs to be assessed, specifications and batch records need to
be written.
- A Health and Safety Review needs to be conducted to ensure the ability to safely handle
the product.
Transfer Protocols
Always strive to develop transfer protocols in such a way that critical steps and
machine differences are adequately challenged. It may be necessary to develop new
operating ranges for the product, in which case one or more batches may be required
at this stage. Remember, the more thoroughly a process is challenged in this early
phase, the more robust that process will be moving forward. A robust process means
reproducible quality, which in turn means fewer rejections down the line. When satisfied
that you’ve nailed down the process, it's time to move through validation.
SUPAC Guidelines and Regulatory Strategy are a set of online FDA guidelines which identify the types of equipment available
for different pharmaceutical manufacturing functions. Let's take milling as an example
of a common manufacturing function covered by SUPAC documents.
Milling equipment can be organized into several different classes, from V-blenders
to ribbon blenders to bin blenders; SUPAC charts allow efficient comparison between
the various classes of milling equipment. During an ideal technology transfer, equipment
should stay within the same class or sub-class, eliminating unnecessary variables
and reducing the number of questions that may come up during FDA pre-approval reviews
and annual reports.
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