Any test during process validation shall investigate to determine the case of failure. Where the case of failure is not obvious, it may useful to us an investigation PROCEDURE to ENSURE that all the possible areas of potential failure are covered. Once the case of the process validation failure has been identified, the failure shall classify into the following categories.

Type I: where the failure can be ATTRIBUTED to an occurrence which is not intrinsic to the process for example, an equipment failure raw material that it can be agreed to complete the validation exercise substituting another batch for the one that failed. This investigation and the subsequent action shall be included in the validation report.

Type II: where the failure may be attribute failure or where the investigation is inconclusive than the validation exercise has failed. In this case the validation TERMS decide and JUSTIFY the course of action to be taken, recording its justification and recommendations.

This decision shall consider:

• Re-testing - if investigation of the analytical results supports the decision.
• Introduction a change in operation parameters, process steps.
• Changing the process equipment or the procedure for using the equipment.
• Suspension of the process validation exercise until further technical evaluation and/or development has been carried out.
• Changing the sampling regime.
• Review of historical data.
• Change of the process validation acceptance criteria.
• Change to an analytical procedure.

Any test during process validation shall investigate to determine the case of failure. Where the case of failure is not obvious, it may useful to us an investigation procedure to ensure that all the possible areas of potential failure are covered. Once the case of the process validation failure has been identified, the failure shall classify into the following categories.

Type I: where the failure can be attributed to an occurrence which is not intrinsic to the process for example, an equipment failure raw material that it can be agreed to complete the validation exercise substituting another batch for the one that failed. This investigation and the subsequent action shall be included in the validation report.

Type II: where the failure may be attribute failure or where the investigation is inconclusive than the validation exercise has failed. In this case the validation terms decide and justify the course of action to be taken, recording its justification and recommendations.

This decision shall consider: