Approaches to validation

Manufacturers should organize and plan validation in a way that ensures product quality, safety and performance throughout its life cycle.

The scope and extent of eligibility and validity should be based on risk management principles.

Statistical calculations should be applied, where appropriate, and scientific evidence should be provided that the process, system or other related aspect is valid.

Eligibility and validation should be done according to predetermined protocols and the results should be properly documented, i.e. in reports

An appropriate and effective quality system should be in place to ensure the organization and conduct of validation.

Senior management should ensure that adequate resources are available to perform validation in a timely manner. Management and individuals responsible for quality assurance should be actively involved in protocol and reporting processes and approvals.

Personnel with appropriate qualifications and experience should be responsible for performing the validation.

A specific program or schedule should be in place to support the planning and implementation of validation activities.

Validation should be performed in a structured manner according to documented protocols and procedures.

Qualification and validation should be performed:
– for new premises, equipment, utilities and systems, and processes and procedures;
– when changes are made depending on the results of the risk assessment;
– Based on the results of periodic reviews where required or indicated.

A written report should be prepared on the results of the validation.

The scope and extent of validation should be based on knowledge and experience, and as a result of quality risk management principles as outlined in the World Health Organization (WHO) guidelines. Where necessary worst-case scenarios or specific challenge tests should be considered for inclusion in the validation, for example, stress load and volume verification in the validation of computer systems.

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