3. SU or third party should ensure the suitability or degree of preparedness of
RU with respect to premises, equipment and supporting staff/services, etc.
4. SU and RU should jointly verify the satisfactory completion and availability
of validation protocols of following: (a) IQ of all pieces of equipment elated
with manufacturing, packaging and analysis at RU site, (b) OQ of all
equipment elated with manufacturing, packaging and analysis at RU site,
(c) qualification of premises and rooms for both manufacturing and
5. The training of the staff/personnel required for specific knowledge (related
with product, process and method) should be implemented by SU and RU
jointly and assessment of training outcomes should also be done jointly.
6. SU and RU should jointly execute the transfer protocol according to checklist
and/or a flow diagram should be prepared which shows a sequence of
steps that are taken to ensure efficient transfer.
7. Any change and adaptations made during TOT should be fully documented.
8. The SU and RU jointly documented the execution of TOT protocol in a
9. There will be a project team which regulate and control the execution of TT
protocol. It consists of experienced staff/personnel of different departments
10. The transfer of the project will be managed by the team. The members of
the team will be from both SU and RU. Each member is designated with
key responsibilities in writing.
11. The team members should have a necessary and desirable qualification,
experience and knowledge to manage the designated aspect of technology
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