TRIPASS XR تري باس

 

WHO Guidelines for Transfer of

Technology

5

WHO Guidelines for Transfer of Technology 61

iii. It involves the transfer of documentation and the ability of demonstration of the

receiving unit (RU) to perform every elements of the transferred technology.

iv. It also demonstrates the ability of RU to perform each aspect of the transferred

technology to satisfy all the parties and related regulatory bodies.

v. Transfer of technology requires:

a. Documented and planned approach

b. Trained and knowledgeable staff

c. Proper operating quality system

d. Documentation of all phases (development, production, quality control)

Three units are involved in the transfer of technology (Fig. 5.1):

1. Sending unit (from where a designated product, process or method is expected to

be transferred)

2. Receiving unit (to where the designated products, process or method is expected to

be transferred)

3. Unit managing the process (mediated the process and it may or may not be a separate

entity).

Principles to be followed for successful technology transfer (as per WHO)

i. The project plan should have quality aspects of the project. The project plan should

be based on the quality risk management principles. Quality risk management is

a systematic process for assessment, control, communication and review of risks

to the quality of the product, process and method across its life cycle.

ii. The RU and SU should have similar capabilities. The facilities and equipment

provided by RU and SU should be operated according to similar operating

principles.

iii. The analysis of technical gaps between RU and SU which includes technical risk

assessment and regulatory gaps should be done as needed. It makes technology

transfer smoother and easier.

iv. There should be the availability of adequately trained staff at RU. Training can

also be given to the staff to make them familiar with upcoming changes.

v. Regulatory conditions of the countries of both RU and SU must be thoroughly

studied and taken into account while the transfer of technology. The regulatory

condition of the respective countries must be interpreted consistently throughout

the procedure.