iii. There should be technology transfer protocol. The protocol is a set of rules on

which all the involved parties agreed while signing memorandum of

understanding (MoU). The technology transfer protocol should list the intended

sequential stages. The protocol should include:

a. Objective: The objective of TT protocol is to elucidate necessary information to

actual manufacturing from R&D by making it simple (by sorting out the

information).

b. Scope: It applies for complete technology transfer of product within the

respective company.

c. Key personnel and their responsibilities: It involves the details of key personnel

like designation and responsibilities.

d. R&D personnel have responsibilities like the selection of raw material,

development of process, identify the critical control point, etc.

WHO Guidelines for Transfer of Technology 67

e. Production personnel have responsibilities like to provide facility and

equipment, performing operations, cross-checking of SOPs, etc.

f. Maintenance department responsibilities are to calibrate and maintain the

equipment.

g. QC personnel is responsible for quality testing of APT, FP and preparation of

certificate of analysis, etc.

h. A parallel comparison of material, methods and equipment: All the details

related with the material, methods and equipment should be there in the

protocol, e.g. a checklist of raw materials, specifications, checklist of

equipment, quality control details of methods, etc.

i. The transfer stages with documented evidence of each critical stage have been

satisfactorily accomplished before next commences: There are different transfer

stages. So, there should be documented evidence such as source document,

primary document, etc. to ensure that each stage has been in control

qualitatively before it will transfer to the next stage.