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SOP on initiating, incorporating, approval and recording changes to the master documents

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

Department
Corporate & General -G
Stores & Warehouse -W
Manufacturing & Packaging -M
Quality Control & Quality Assurance -Q
Human Resources -H
Engineering -E
Safety Health and Environment -S
The fourth digit is an alphabet and represents the year in which change takes place

YearsCode
2018-19A
2019-20B
2020-21C
2021-22D

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

Related SOP: SOP on design, print, issuance, and control of logbooks

Procedure:

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.

Initiating change

  • 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
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