WHO Expert Committee on Specifications for Pharmaceutical Preparations Fifty-third report

11.2 Revalidation should be done based on the identified need and principles of
risk management.
11.3 Any changes made to, for example, procedures, processes and methods,
should be managed through the change-control procedure. The extent of
validation or revalidation as a result of such a change should be determined
based on principles of risk management.

11.4 Where appropriate, periodic revalidation may be performed.

12. Process validation

For recommendations on process validation, see reference (3).

13. Change management

13.1 Changes should be controlled in accordance with the appropriate quality
management system.

13.2 When a change is initiated, consideration should be given to previous

changes and the impact of the cumulative effect of the changes. The scope
and extent of qualification and validation should be determined based on
risk management principles.

14. Deviation management

14.1 Any deviation during qualification and validation should be appropriately
managed (e.g. investigated, evaluated, the impact assessed, and
documented) through an appropriate quality management system.
WHO Technical Report Series, No. 1019, 2019

14.2 Corrective actions should be considered.

15. Calibration and verification

15.1 Calibration and verification of equipment, instruments and other devices,
as applicable, should be initiated during installation qualification, to ensure
that the system operates according to the described specifications and
because the calibration status could have been affected during transport
and installation.

15.2 Thereafter, it should be performed at regular intervals in accordance with

a calibration programme and SOPs.
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