During the transfer process: If there are any then RU should communicate it with

SU to understand the potential impact on the quality of a product.

After communication, based on the information gained from SU, RU should consider

own capabilities, so that it can be able to develop relevant plant operating procedures,

facilities, equipment and documentation before the start of production.

Process development at RU: Following steps should be there during process

development at RU

i. Suitability and qualification of facility and equipment should be compared and

assessed.

ii. Critical steps like hold times, end-points, sampling points and sampling

techniques should be detained.

iii. SOPs should be written and approved for all production operation, packaging,

cleaning, testing and storage.

iv. Stability, information evaluation should be done with the generation of sitespecific data (if required)

v. Regulatory requirement compliance should be there for any change.

vi. Manufacturing process, the flow of personnel and materials at RU should be

described.

Packaging

Packaging transfer has the same importance as production transfer. The steps to be

followed during packaging transfer are:

a. Procedural patterns during packaging transfer should be the same as in case of

production transfer.

b. SU should transfer the information to RU regarding

1. Specification of a suitable container and closure system

2. Design, processing, packaging and labelling requirements

3. The requirement of tamper-evident and any other anti-counterfeiting measures

which are needed for the qualification of packaging components at RU

c. Specification which includes drawings, material, artworks should be given by SU

to RU for quality control testing of packaging components.

d. Based on the information RU should perform a stability study initial qualification

of packaging components to ensure:

1. Safety

2. Compatibility

3. Performance of packaging material.

WHO Guidelines for Transfer of Technology 79

Cleaning