SOP for Change Control Procedure
Learn how to write SOP for Change Control Procedure, ensuring systematic management of changes in pharmaceutical processes for compliance.
1. PURPOSE
To describe procedure for evaluating, documenting, approving, and implementing changes to ensure compliance with regulatory requirements and maintain product quality, safety, and efficacy.
2. SCOPE
This SOP is applicable to all changes impacting pharmaceutical products, processes, equipment, facilities, utilities, raw materials, packaging materials, analytical methods, and quality management systems within the organization.
3. RESPONSIBILITIES
3.1 Change Initiator is responsible to identify and propose the change then provide sufficient information and justification for the change.
3.2 Department Head is responsible to review the proposed change for technical feasibility and departmental impact.
3.3 Change Control Committee (CCC) is responsible to review significant changes and approve changes with potential cross-departmental or regulatory impact.
3.4 Quality Assurance (QA) Department is responsible to evaluate the overall impact of the proposed change and ensure proper documentation and implementation.
3.5 Head of the Quality Assurance (QA) is responsible to approve or reject the change based on risk assessment and regulatory requirements.
3.6 Regulatory Affairs Department is responsible to take approval from regulatory authority if needed.
4. ACCOUNTABILITY
Head of the Quality Assurance Department
5. ASSOCIATED DOCUMENTS / REFERENCES
5.1 SOP Preparation, Authorization and Distribution of SOP (SOP for SOP)
6. PRECAUTIONS
6.1 Changes must be initially reviewed and assessed by Quality Assurance in their respective areas and must decide which functions need to be involved. Careful consideration must be given for the inclusion of Environmental Health & Safety (EHS) operations for a review of proposed changes to processes, facilities, utilities and equipment
6.2 There must be an approved, written Contracts/Technical Agreement between company and suppliers/ contractors to ensure that the changes will be informed the company by suppliers/ contractors.
6.3 All employees involved in the change control process must be trained on this SOP.
7. PROCEDURE
7.1 Change proposal for manufacturing site:
7.1.1 Raise the change proposal using Change Control Request (CCR) Form template as annex-1 in full details for all changes.
7.1.2 Department Heads review the Change Control Request CCR Form for feasibility and departmental impact.
7.1.3 Send the change proposal to Quality Assurance with any data or documents available to support the change.
7.1.4 Complete all sections of the Form; this must be done by the originating department.
7.1.5 QA conducts an initial evaluation to categorize the change as minor or major.
7.1.6 Organize change control meeting, normally within a week of proposal raised or as appropriate to the urgency. Chalk out a detailed time and events consulting with the initiator.
7.1.7 Assess preliminary benefit or risk of the proposed change. (To be performed by the coordinator together with the change control committee).
7.1.8 Assess the Environment, Health, and Safety (EHS) impact on the proposed change.
7.1.9 Circulate the change control proposal to every member for review.
7.1.10 Identify the change proposal requiring Managing Director’s approval.
7.1.11 Identify the change proposal requiring regulatory approval.
7.1.12 Inform the Drug Regulatory Affairs of the dates of implementation of all changes requiring regulatory action(s).
7.1.13 Consider implication on the validation and whether re-validation is required or not.
7.1.14 Apply to the regulatory authority for approval, if required.
7.1.15 Send the change control proposal to Head of Quality Assurance for approval.
7.1.16 Implement change proposal as per change control conditions implied in specific protocol and also include sufficient specific data.
7.1.17 Notify all committee members and sign the Quality Assurance as per Annex-1.
7.2 Change proposal for others (Documents, Packaging materials, Pharmacopoeial)
7.2.1 Notify the change proposal to the coordinator and enter full details of the proposed change onto “Change Control Request Form”.
7.2.2 Complete all sections of the form this must be done by the Change Control Originating Department.
7.2.3 Send the completed Form to the Quality Compliance together with any data or documentation available to support the change.
7.2.4 Circulate the change control proposal to every member for the committee for review and approval.
7.2.5 Apply to the regulatory authority for approval, if originated by corporate.
7.2.6 Implement the change proposal.
7.2.7 Notify all committee members and sign the Form in Annex-1.
7.3 Change Material’s For Local Customer
7.3.1 Any physical change of product like appearance (product color, shape or size), capsule shell, packing mode should be informed the customer by circular through newspaper.
7.4 Change Material’s For Foreign Customer
7.4.1 Any physical change of Product like appearance (Product color, shape or size), Capsule shall, packing mode should be informed the customer by e-mail.
7.5 Change Control Numbering System
7.5.1 Every change control proposal must have an entry number. The numbering system of change control proposal is described below:
CCR / 001 / XX
The above alphanumeric digit denotes
CCR = Change Control Request
001 = Serial Number
XX = Calendar year last 2 digit.
As for example: CCR / 001 / 25
8. DEFINITIONS AND ABBREVIATIONS
8.1 Deviations: Deviation usually represents an unplanned change which may occur for a variety of reasons during operations or may be observed to have happened after the operation. Normally deviations are not permanent and represent single events.
8.2 Change: Usually refers to a planned attention which is documented and considered before implementation. Changes are typically either permanent or have a set duration.
8.3 Change Control: A formal process used to manage modifications to ensure quality and compliance.
8.4 Minor Change: A change with minimal impact on quality or regulatory requirements (e.g., updates to labels).
8.5 Major Change: A change with significant impact on quality, safety, efficacy, or regulatory status (e.g., changes in formulation or manufacturing process).
8.6 Temporary Change: A short-term modification intended to address specific circumstances.
8.7 Change Control Committee: Committee may be constituted with the following members such as Head of Quality Assurance, Coordinator, Production Manager, and Head of Engineering. If required it can be extended
8.8 QA: Quality Assurance
8.9 EHS: Environment, Health, and Safety
8.10 QC: Quality Control
8.11 SOP: Standard Operating Procedure
9. ANNEXES
9.1 Annex-1: Change Control Request (CCR) Form
9.2 Annex-2: Flow Chart of Change Control Process
10. REVISION HISTORY
| Version | Date | Description of Change | Reviewed By | Approved By |
| 1.0 |