Change control requires a written procedure (change control program) to regulate at least the following points:
• What sorts of changes does change control consider; for which regions does this working guidance apply?
• Who can recommend and initiate changes? At what of level of management can initiate change control in the organization.
• How are changes mentioned (forms, methods of communication)?
• How are changes evaluated, who is answerable for evaluation?
• What are the measures necessary for carrying out the change determined; who tracks and monitors the changes required?
• Who is liable for the execution and monitoring of all necessary measures?
• How is the change control team is formed who are its members and the duties the change control team?
• Documentation of Change control relevant SOPs, formats?
• Who is responsible for approving changes?
• What are the exceptional guidelines for critical changes?
Transparency in change control implementation:
If the change affects a manufacturing or testing process, then the qualified person must take this into consideration when releasing the batch to the market. The relevant individual should document and archive all the changes in a well documented and comprehensible format. Further all the relevant related and supporting raw data and should be accessible to the regulatory and other third party Audits. (updated on 22/11/2020).