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WHO Guidelines for Transfer of Technology 75

iii. Consideration should be given to the technical expertise, site technology and

capabilities of RU. It is done so that the plans can be put in place at the RU.

iv. SU should jointly develop a protocol with RU for relevant information transfer

and to help RU in developing the comparable process.

Starting Material

The specification and relevant functional characteristics related with starting material,

i.e. API and excipients which are to be used at RU should be consistent with materials

used at SU. The properties that may influence the process or product should be

identified and characterized.

API

SU should provide open part* information of Drug Master File (DMF) or APIDMF or

ASMF to RU. SU can also give any other equivalent information to RU which is

important for the manufacturing of pharmaceutical products. This information may

include the following:

(*Note: There are two parts in DMF)

Open part: Applicants part

Closed part: Have confidential information and can be disclosed only before regulatory

authority)

i. Manufacturing and associated supply chain.

ii. Steps of API to be transferred.

iii. Flowchart of synthesis pathway, raw material entry point, critical steps, process

controls and intermediates.

iv. Where the relevant, definitive physical form of API and any polymorphic and

solvate forms are included

v. Solubility profile.

vi. Partition coefficient, including the method of determination for transdermal

dosage forms;

vii. Intrinsic dissolution rate, including the method of determination for transdermal

dosage forms;

viii. Particle size and distribution, including the method of determination for solid,

inhaled and transdermal dosage forms;

ix. Bulk physical properties, including data on bulk and tap density, surface area

and porosity as appropriate for solid and inhaled dosage forms;

x. Compaction properties for solid dosage forms;

xi. Melting point range for semi-solid or topical dosage forms;

xii. pH range for parenteral, semi-solid or topical, liquid and transdermal dosage

forms;