Standard Operating Procedure (SOP) for Change Control Management

This Standard Operating Procedure (SOP) outlines the requirements to ensure that changes to systems, products, processes, procedures, and documents are thoroughly evaluated, documented, and approved prior to implementation. The objective is to minimize risks to product quality, compliance, and patient safety.

This SOP applies to changes that may impact:

- Product Quality: Including product introduction, discontinuation, scale-up, and facility changes.

- Shelf Life: Extension or reduction.

- Production, Packaging, and Labeling: Including specifications and intermediates.

- Analytical Methods and Stability Protocols: Including templates and master plans.

- Equipment and Utilities: Including preventive maintenance and upgrades.

- Materials and Supply Chain: Including vendor changes and material sourcing

- SOP for Technology Transfer of Drug Products

- Risk Management SOP

- SOP for Corrective/Preventive Action Recommendation

Quality Head/Designee:

Implement and manage the change control process.

- Evaluate the impact of changes on quality, compliance, and other processes.

- Notify Regulatory Affairs (RA), FDD, PDD, ADD, customers, and market representatives.

- Classify changes as Level I, II, or III.

- Ensure proposed changes are evaluated for potential impacts on documents, product characteristics, validation, and materials.

Initiator/Responsible Person (RP):

- Define, document, and discuss objectives, scope, and deliverables of the Change Control Record (CCR).

- Initiate the CCR and ensure implementation according to the procedure.

- Manage risk assessments and resolve issues in coordination with stakeholders.

- Ensure all activities related to change implementation are satisfactory and verified.

Regulatory Affairs (RA) Head/Designee:

- Review proposed changes for regulatory impact.

- Communicate changes to Regulatory Agencies or customers via variations (e.g., CBE, PAS) or annual reports.

QA Head/Designee:

- Approve or reject changes based on quality and GMP compliance.

- Perform impact and risk assessments.

- Approve CCRs and classify change levels.

- Ensure closure of all action items and perform trend analysis of changes.

- Change Control Record (CCR): A documented process to manage changes and ensure they are evaluated, approved, and implemented effectively.

- Like-for-Like Change: A replacement where the specifications and functionality remain unchanged.

- Level I (Minor Change): Minimal potential impact on product quality or regulatory compliance.

- Level II (Moderate Change): Moderate potential impact on product quality or regulatory compliance.

- Level III (Major Change): Significant potential impact on product quality or regulatory compliance.

Initiation of CCR:

1. The initiator discusses the proposed change with the Department Head and key stakeholders (e.g., QA and RA) to ensure consensus.

2. Once agreement is reached, the initiator initiates the CCR.

3. QA assigns a unique change control number (e.g., CC/XX/ZZZ) and issues the CCR to the initiator.

Filling the CCR:

- Section A: Include details such as the change category, target completion date, title, and impact analysis.

- Section B: Perform a risk assessment and impact analysis using Annexure 4.

- Section C: Classify the change level (I, II, or III) and obtain approvals from relevant departments.

- Section D: Document action items and their closure.

- Section E: Implement the change and ensure closure of all action items.

- Section F: Monitor post-change effectiveness and perform trend analysis.

Approval and Implementation:

- Changes are classified and approved based on their potential impact.

- All action items must be closed before final approval.

- Post-change reviews are conducted to ensure the change achieves its objectives without adverse impacts.

Closure and Archiving:

- The CCR is closed once all action items are implemented and verified.

- The document is archived for future reference.

- Annexure 1: Change Control Record

- Annexure 2: Change Control Register

- Annexure 4:  Impact Analysis

- Annexure 5: Change Control Annexure

- Annexure 7: Change Information Form

- Annexure 10: Department Selection Matrix