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

packaging at RU.

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.

68 Industrial Pharmacy II

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

summary in the report.

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

involved.

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

transfer.