SOP Title: Change Control Management
- Objective:
To document and evaluate approval system for initiation and/or implementation of technical changes in procedures, Raw Materials, Packing Materials, manufacturing process, Analytical Testing Methods, equipments, utilities and operating environment etc.
- Scope:
This SOP covers the following:
- Change/s in Quality System and its documentation.
- Manufacturing Process or Testing Method and its Equipment and/or Instrument.
- Approved Facility/Utilities, Specifications (Raw, Packing, In-process, Finished
Product/Finished Product shelf life).
- Modifications in Water System / HVAC System or Compressed Air System.
- Storage Conditions, Formulations, Vendors of Raw and Packing Materials, Packaging Material, Packaging Configuration/ Style / Text Matter and Artworks etc.
- Responsibility:
Concerned Department: To identify and assess need of change required & initiate through Change Control procedure.
QA Department: To review and approve the change; to verify the implementation and ensure compliance of the procedure.
Other Departments: To analyse the impact of the change in their respective departments and review the change as applicable.
- Accountability:
Head Quality Assurance and Head Concerned Department
- Procedure:
- Definition:
Change: Change includes any Addition to, Deletion of or Modification to a System, Process, Materials, Product, Procedure and Equipment or Instrument. Changes can be categorized as follows:
- Minor change:
A change that may not have an impact on the identity, quality, purity, strength, stability, safety
and efficacy or physical characteristic of the product.
- Major change:
A change that is likely to have an impact on quality of the product, but does not make any
significant change in the final quality of the product.
- Critical change:
A change that has a significant impact on the quality and/or safety of the final product
- Procedure
| 5.2.1 | A proposal for any change i.e. addition/deletion/modification shall be initiated in change control format. | ||||||||||||||||||||||||||||||||||||||||||||||
| 5.2.2 | The Change Control Log for all changes taking place within the facility shall be maintained in format. (having the details like: Change Control No., Date, Initiating Department, Document No., Description of change, Type of change i.e. Minor/Major/Critical, Change Control Approved/Rejected, Closing date, Closing Remark and Sign of QA). | ||||||||||||||||||||||||||||||||||||||||||||||
| 5.2.3 | All supporting and reference documents shall be attached to the change control form before sending for QA approval.
e.g.: Draft SOP, Proposed layout design, Draft STP, Specification, Guideline, Regulatory document etc as applicable. |
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| 5.2.4 | Change control form and supporting document shall be reviewed for its appropriateness before sending to QA Department. | ||||||||||||||||||||||||||||||||||||||||||||||
| 5.2.5 | If changes are more and cannot accommodate in space provided in Change Control Form then separate annexure shall be prepared by making column for proposed change, existing procedure and justification for change with Prepared By, Checked By, Sign and Date. | ||||||||||||||||||||||||||||||||||||||||||||||
| 5.2.6 | After review of Concerned Department Head, initiator shall submit the change control form to QA Department for approval. | ||||||||||||||||||||||||||||||||||||||||||||||
| 5.2.7 | A Change Control number shall be allotted to each change as mentioned below:
CCQAYYNNN Where, CC denotes Change Control, QA denotes Department Code for Quality Assurance Department, YY denotes last two digits of the current year and NNN denotes three digits serial number (e.g. 001,002,003…..). For Example:-first change notified for year 2024 shall be numbered as CCQA24001. |
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| 5.2.8 | Review of proposed changes and supporting documents shall be done before approval. | ||||||||||||||||||||||||||||||||||||||||||||||
| 5.2.9 | If needed, additional supporting documents may be required with respect to proposed changes. | ||||||||||||||||||||||||||||||||||||||||||||||
| 5.2.10 | The Change Control form shall be circulated to Concerned Department for impact assessment and comments. Impact of proposed changes on other department shall also be assessed. | ||||||||||||||||||||||||||||||||||||||||||||||
| 5.2.11 | After receiving comments from all Concerned Department QA shall review the comments to assess any other impact of the change. | ||||||||||||||||||||||||||||||||||||||||||||||
| 5.2.12 | After complete assessment, change shall be approved or rejected. | ||||||||||||||||||||||||||||||||||||||||||||||
| 5.2.13 | The review of a proposed change shall involve activities such as conducting experiments, analysis, review of master documents, stability data etc if required. | ||||||||||||||||||||||||||||||||||||||||||||||
| 5.2.14 | In case of a change pertaining to the product manufactured for specific customer on contract basis, approval of the change shall be taken from the customer prior to the implementation by sending notification of the proposed change with justification and proposed change data generated to support evaluation of the change. Upon receipt of acceptability from the customer, the change shall be implemented. | ||||||||||||||||||||||||||||||||||||||||||||||
| 5.2.15 | The change shall be implemented with immediate effect based on the information, review and recommendation. | ||||||||||||||||||||||||||||||||||||||||||||||
| 5.2.16 | After implementation of the proposed change necessary data shall be collected and forwarded to Head QA. | ||||||||||||||||||||||||||||||||||||||||||||||
| 5.2.17 | The verification shall be carried out to ascertain whether the changes and the consequent changes have been implemented satisfactorily. | ||||||||||||||||||||||||||||||||||||||||||||||
| 5.2.18 | All the documents undergoing changes due to implementation of change control shall be revised and controlled as per SOP. | ||||||||||||||||||||||||||||||||||||||||||||||
| 5.2.19 | The change control shall be closed within 30 days from the date of initiation. However, based on the nature of the change, extent of the work involved or any experiments / validations studies to be carried out; extension to closing time can be approved for completion and it shall be written as in the Change Control forms. | ||||||||||||||||||||||||||||||||||||||||||||||
| 5.2.20 | Trending of changes shall be done once in a year during product quality review. If frequent changes observed on a particular subject, then Corrective and Preventive Action shall be followed to reduce the number of changes. | ||||||||||||||||||||||||||||||||||||||||||||||
| 5.2.21 | Recommended supporting studies for changes | ||||||||||||||||||||||||||||||||||||||||||||||
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| 5.2.22 | List of Major and Critical Changes | ||||||||||||||||||||||||||||||||||||||||||||||
The list is not exhaustive and can be extended based on practical changes occurring. |
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- Abbreviation:
| Abbreviation | Expansion |
| SOP | Standard Operating Procedure |
| QA | Quality Assurance |
| RM | Raw Material |
| PM | Packing Material |
| BMR | Batch manufacturing Record |
| STP | Standard Test Procedure |
*Note – Ready to use SOP available in “DOWNLOAD” Section.