In technology transfer process (as per WHO guidelines) analytical method transfer

is a critical step that ensures RU capabilities to produce and test the same product as

by SU. Analytical method transfer comes under the quality control section.

All the analytical testing methods that demonstrate compliance of product

(which is to be transferred) will be transferred with registered specifications. The

analytical method used to test pharmaceutical products, starting material, packaging

components, cleaning should be first implemented at a laboratory before process

validation at RU. Process validation sample may be tested at RU, SU, or any other 3rd

laboratory.

80 Industrial Pharmacy II

There is an analytical method transfer protocol which is to be prepared before

analytical method transfer. It includes:

i. Objectives, scope, roles and responsibilities of both SU and RU

ii. Material and method specification

iii. Experimental design and acceptance criteria

iv. Documentation

v. Reference

vi. Procedure for the handling of deviations

vii. Signed approval from the designated authority

viii. All details regarding reference material (like starting material, FP, intermediates,

etc.)