iv. These guidelines are applied to all dosage forms. However, needs to be adjusted

case by case basis. Such as certain aspects should be controlled closely in case of

sterile products, aerosols, metered dose. WHO issued different guidance name

as “WHO guidance on manufacture of specific pharmaceutical products” in this

regard.

v. The guideline addresses the following areas related with SU and RU

a. Transfer of development and production (processing, packaging and cleaning)

b. Transfer of analytical methods for QA and QC.

c. Skills assessment and training

d. Management and organisation of the transfer

e. Assessment of premises and equipment

f. Documentation

g. Qualification and validation

These guidelines do have some limitations regarding its scope like:

i. As each transfer is unique, the provision of a comprehensive set of guidelines is

beyond the scope of these guidelines.

ii. These guidelines do not provide guidance on legal, financial or commercial

consideration associated with technology transfer projects.