Change Control Management Quiz

Change Management is a systematic approach to proposing, evaluating, approving, implementing and reviewing changes based on what document?

• ICH Q8

• ICH Q10

When should the effectiveness of a permanent change be verified?

• After three successive successful batches for permanent product-related changes

• After one successful batch for permanent changes

Main Function/s of Change Control

• Validating the changes which can alter the product quality, regulatory or GMP requirements.

• Analysis of the change and monitoring of the impact of change.

• Review of the change

• All of the above

A formal system by which qualified representatives of appropriate disciplines review proposed or actual changes that might affect the validated status of facilities, systems, equipment, or processes

• Change Control

• CAPA

• Deviation Control

• Self-Inspection

The changes proposed and made in any procedure or process should be reviewed, established, documented and approved by the concerned authorities.

• True

• False

Changes in material, material specifications, and material source are from what nature of proposed change?

• Product

• Material

• Equipment

• Utilities/Facilities

The initiator must ensure that the affected area of the change will be duly informed before implementation.

• True

• False

All changes should only be VERBALLY discussed by representatives of Production, QC/QA, R&D, Engineering and Regulatory Affairs during coffee breaks.

• True

• False

Required data, documents, or actions to justify the change request

• Pre-work requirements

• Proof of Implementation

• Close-Out Requriements

Change for a specified limited period or scenario with the intention of returning to the previous state.

• Permanent Change

• Temporary Change