In an analytical method transfer, both SU and RU have their responsibilities. These

are given in Table 5.3.

Appropriate training should be provided. All training activities and outcomes should

be documented. Reference to compendia monographs (like IP, BP, USP, etc.) where

available, is expected.

Table 5.3: SU and RU responsibilities in analytical method transfer

Responsibilities of Description

SU i. Provide method-specific training for analysts and other quality control

staff, if required;

ii. Assist in analysis of QC testing results;

iii. Define all methods to be transferred for testing a given product, starting

material or cleaning sample;

iv. Define experimental design, sampling methods and acceptance criteria;

v. Provide any validation reports for methods under transfer and

demonstrate their robustness;

vi. Provide details of the equipment used, as necessary (part of validation

report, if available) and any standard reference samples;

vii. Provide approved procedures used in testing; and

viii. Review and approve transfer reports

RU i. Review analytical methods provided by the SU, and formally agree on

acceptance criteria before the execution of the transfer protocol;

ii. Ensure that the necessary equipment for QC is available and qualified

at the RU site. The equipment used by the RU during the analytical

transfer should meet appropriate specifications to ensure the

requirements of the method or specifications are met;

iii. Ensure that adequately trained and experienced personnel are in place

for analytical testing;

iv. Provide a documentation system capable of recording receipt and

testing of samples to the required specification using approved test

methods, and of reporting, recording and collating data and designation

of status (approved, rejected, quarantine);

v. Execute the transfer protocol;

vi. Perform the appropriate level of validation to support the

implementation of the methods;

vii. Generate and obtain approval of transfer report

WHO Guidelines for Transfer of Technology 81

Possible experimental designs and acceptance criteria for the main analytical testing

methods are mentioned in the table in WHO guidelines for transfer of technology. The

table represents high-level guidance to apply the general principle that method transfers

should account for the variability and sensitivity of the method and the specifications

for the quality parameter. Alternative procedures and acceptance criteria may be

applied based on science and the characteristics of the analytical method and the

analyte. The table includes pssible experimental designs and acceptance criteria for

analytical testing (Figs 5.6 to 5.8).