Back to Library·Change Control
Quality Assurance
Intermediate
Last updated: Jul 8, 2026
Official signed PDF · SIPL/QAS/002
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Change Control

PURPOSE

  • To establish a documented procedure for identification, evaluation, approval, implementation, verification, and closure of changes that may affect product quality and safety, or the validated status of facilities, equipment, utilities, systems, processes, materials, documents, or computerized systems.

SCOPE

  • This SOP is applicable to temporary and permanent changes. Changes related to Standard Operating Procedures (SOPs), manufacturing process, manufacturing equipment / machine or operating instrument, analytical method, specification / standard test method, or other miscellaneous documents.

REFERENCE(S) & ATTACHMENTS

  • References
    • ISO 15378:2017 & ISO 9001:2015, 8.5.6
  • Attachments
    • Attachment I: Change Control Form - SIPL/QAS/002/F01/00
    • Attachment II: Change Control Numbering Procedure - SIPL/QAS/002/F02/00
    • Attachment III: Change Control Log - SIPL/QAS/002/F03/00

RESPONSIBILITY

  • QA Department Person
    • To prepare the SOP for the Change Control Procedure.
  • Concerned Department Person (Initiator)
    • To identify the change.
    • To provide the relevant supporting data to QA.
  • Quality Assurance
    • To make necessary entries in the change control record.
  • Quality Assurance Head
    • To review the recommendations for the possible impact due to the change.
    • To approve the change control for execution.
    • To ensure implementation of the defined system.
  • Department Head / Plant Head
    • To review the recommendations for the possible impact due to the change.
    • To approve the change control form for execution.
    • To ensure implementation of the defined system.

DISTRIBUTION

  • Quality Assurance
  • Quality Control
  • Production
  • Store / Warehouse
  • Engineering
  • Human Resource and Administration

DEFINITION(S) & ABBREVIATION(S)

  • Definitions
    • Change Control (CC) Procedure: A formal, controlled, documented process by which qualified representatives from appropriate disciplines propose, review and make changes to an approved system.
    • Corrective Action and Preventive Action (CAPA): CAPA focuses on the systematic investigation of discrepancies (failures and/or deviations) in an attempt to prevent their recurrence (for corrective action) or to prevent occurrence (for preventive action).
  • Abbreviations
    • CAPA: Corrective Action and Preventive Action
    • CC: Change Control
    • QA: Quality Assurance
    • QC: Quality Control
    • cGMP: current Good Manufacturing Practices

PROCEDURE

  • Procedure for Change Initiation
    • Upon identification of the need for change, the concerned person shall fill the change control form as per Attachment I with proper justification.
    • Change Control Number
      • Assign the change control number as per the CC numbering procedure explained in Attachment II.
    • Assigned By
      • The QA person who is issuing the change control shall put his/her initial with date.
      • The QA person mentions the name of the document, such as Standard Operating Procedure, Standard Test Method, Specification or equipment-related changes, etc.
      • The QA person mentions the document number (BMR No., SOP No., Specification or STM No., etc., with version number) for which the change is being initiated.
  • Evaluation for Requirement of Change
    • If not justifiable
      • If the requirement for change is not justifiable or not agreed, the department head shall include justification to close the change control. Approval for the same shall be taken from the QA head and it shall be sent to QA for closing.
    • If justifiable
      • If the requirement for change is justifiable or agreed, the department head shall evaluate the requirement for change and shall approve the same if found satisfactory. Evaluation of the risk(s) associated with all proposed changes shall also be done and the subsequent impact on quality shall be checked (in some cases, record / data may be required as supporting documents for evaluation).
    • Approval for execution
      • After ensuring recommendations under impact analysis and signature of the impacted department head, the concerned department head shall give approval for the execution and shall arrange to get the approval from QA and Plant Head.
  • Execution in a Time Frame
    • The concerned person shall execute the change in coordination with QA and the impacted department in a given time period, which is 30 days.
  • Review of Impact Evaluation / Recommendations
    • After execution of the change, the concerned department head and the impacted department head shall submit the change control along with supporting data / assessment report to QA for the review of impact evaluation / recommendations.
  • Change Control Implementation Status (Evaluation and Conclusion)
    • Based on review of the above data / assessment report / outcome / results (satisfactory / not satisfactory), Quality Assurance shall make the final conclusion, whether the change was executed successfully or not, and shall close the same after ensuring implementation details, i.e. effective batch / document number and date.
    • Any changes in production or quality that can have an effect on finished product quality shall be notified to all the concerned customers before implementation.
  • Time Extension
    • If the assigned change is not done within the time limit (30 days), then the QA head shall directly approach top management to take immediate action and close the change within 7 days.

REVISION HISTORY

Revision No.

Effective Date CC No. Details of revision: New SOP Attachment-II : Change Control Numbering Procedure .Change control number will be changed every year. .Change control number will be item dependent and a separate number will be issued to monitor change in individual items. .Change control number will be an alphanumeric system containing 9 digits, example: CCYY/B001. .The first two "CC" alphabets will stand for Change Control. .The next two "YY" characters will stand for the year, like 26 for year 2026, 27 for year 2027, etc. In year 2026 it will be 26. .The next character is a slash ( / ), followed by a capital letter that stands for item identification like S, R, F, etc. These letters represent the item code as follows: Code Meaning

R

Change in raw material.

F

Change in finished product.

M

Change in miscellaneous items.

I

Change in intermediates / in-process.

S

Change in SOP / Documents.

E

Change in Equipment / Instrument. .The last three numerical digits will stand for the serial number, starting every year from 001 and changing after each change in the said item. For example: for a change related to SOP in 2026, the change control number shall be CC26/S001. Format No.: SIPL/QAS/002/F02/00

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