Objective: To initiate, incorporate, approve and record changes to the master documents.
Scope: This Sop is applicable for changes to the master documents.
Responsibility: All the functional Heads.
Accountability: Head – Quality Assurance.
Filling procedure for Document Change Control
DCC No: Document change control number is entered, and DCC No., will be allotted using the following guidelines.
Document change control is a 6-digit number DCAYNN
The first and second digit are alphabets and represents the document change control
The third digit is the alphabet and represents the department
Corporate & General -G
Stores & Warehouse -W
Manufacturing & Packaging -M
Quality Control & Quality Assurance -Q
Human Resources -H
Safety Health and Environment -S
The fourth digit is an alphabet and represents the year in which change takes place
The fifth and sixth are numerical and represent running numbers.
Document Number: SOP No., AM No., Spec No., Document format No., or Version No., as relevant shall be entered here.
Document Name: The title of the Document shall be entered here.
Existing Revision No: The revision number of the document under revision shall be entered here.
New Revision No: The new revision number of the document under revision shall be entered here.
Details of revision Existing: The details in the existing documents that are under change shall be entered here.
Details of revision–Proposed changes: The details of proposed changes shall be entered here.
Reasons that warranted the change: Reasons, which demand the proposed changes, shall be entered here.
Changes initiated by: The person who is initiating the change shall sign here
Date: Initiator shall put the date here.
HOD of initiating Department: HOD of the initiating department shall sign here
Date: HOD of the initiating department shall put the date here.
Regulatory filing requirements: Regulatory filing requirements identified shall be entered here.
Changes Approved/Rejected/Circulated: When change Approved strike off Rejected and Circulated, When change Rejected strike off Approved and Circulated When change Circulated strike off Approved and Rejected.
HOD Quality Assurance: HOD of quality assurance shall sign here
Date: HOD of quality assurance shall put the date here
Departments: The name of the departments shall be entered in this column
Comments: Comments of the departments shall be entered here.
Date and sign: The HOD of the concerned departments shall sign here with the date.
Changes Approved/Rejected: When change Approved strike off Rejected, When change Rejected strike off Approved.
Filling procedure for Revision History
Document Name: The document name or Title Document shall be entered here.
Document Number: SOP No., AM No., Spec No., or Document format No., or Version No., as relevant shall be entered here.
Effective Date: Effective date of the document shall be entered here
Reasons for revision: Reasons for revision shall be entered here
Reasons for change:
- Change in Operating procedures.
- Change in Raw material, Intermediate, In-process, Packing Material, Finished Product Specifications, and Test Procedures.
- Change in process.
- Change in compendial and regulatory requirements.
- Improvement of existing master documents.
- Prepare a new document as per the changed requirement.
- After duly reviewing the document functional Head shall fill out the Document Change Control and submit it to the Head QA.
Review and Approval
- QA shall review the impact of the Document change proposal.
- Changes that involve customers and regulatory requirements shall have concurrence from Regulatory Affairs before approval of the document.
- QA shall approve or reject the proposal, in case of document applicable within the initiating department.
- QA shall circulate the proposed document to the related departments for comments in case of interdepartmental documents.
- In case of no objections from the related departments, QA shall approve the document.
- In case of objections from the related departments, QA shall call for a meeting with the related departmental personnel.
- Based on the outcome of the discussions QA shall approve or reject the proposal.
- When the proposal is approved, the master document shall be printed out and signed appropriately.
- Revision history is maintained in the revision history document