SOP for Regulatory Change Control

Purpose

This SOP aims to provide an organized method for monitoring and controlling regulatory requirements, procedures, and documentation modifications. It also ensures adherence to relevant regulations and reduces the possibility of non-compliance.

Scope

This SOP covers all organizational regulatory changes, such as modifications to submissions, labeling, rules, regulations, and other pertinent documents.

Responsibilities

Department of Regulatory Affairs:

• Control and direct the process of regulatory change control.
• Assign staff members to the task of examining and evaluating changes to regulations.
• Organize the dissemination of information and the application of new regulations.
• Make sure that the regulations about change control are followed.

The Board of Change Control (CCB):

• Examine and accept any suggested changes to the regulations.
• Examine the effects and dangers posed by the suggested modifications.
• Make suggestions for how to proceed with implementation and follow-up measures.

Multidisciplinary Teams:

• Determine and share any suggested modifications that have an effect on regulatory activities.
• Provide the information and input that are required for the assessment of regulatory changes.
• Execute authorized modifications within their designated spheres of authority.

Procedure

Identification and Evaluation of Changes:

• Determine and record any suggested changes to the regulations, along with their nature, justification, and possible effects on regulatory compliance.
• Assess how suggested modifications would affect current submissions, procedures, and regulatory documents.
• Evaluate the possible hazards connected to the modifications, like non-adherence, security issues, or effects on product quality.

Assessment and Acceptance of Changes:

• Call a meeting of the Change Control Board (CCB) to discuss and assess suggested modifications.
• Go over the impact analysis, risk assessment, and change assessment.
• Assess the proposed changes' necessity, viability, and possible repercussions.
• Accept or reject the suggested modifications depending on the assessment and suggestions made by the CCB.

Change Implementation:

• Develop an implementation plan for approved changes, including timelines, responsibilities, and necessary resources.
• Communicate approved changes to the relevant stakeholders, such as regulatory affairs personnel, cross-functional teams, and external partners, as applicable.
• Update regulatory documents, procedures, submissions, and other relevant records to reflect the approved changes.
• Conduct any required training or awareness programs to ensure personnel are aware of and equipped to implement the changes effectively.

Documentation and Change Verification:

• Make sure that the authorized changes have been implemented successfully by using the right techniques, like document reviews, system audits, or process inspections.
• Record the specifics of the change implementation, such as the dates, the steps you took, and any deviations or problems you ran into.
• Ensure that all change control operations—such as requests for changes, assessments, approvals, and verification outcomes—are accurately documented.

Abbreviations

SOP: Standard Operating Procedure

CCB: Change Control Board

Annexure

Nil

Revision History

Nil

ALSO READ: SOP for Regulatory Data Integrity