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SOP to Initiate, Incorporate, Approve and Record Changes to the Master Documents

Objective: To initiate, incorporate, approve and record changes to the master documents.

Scope: This Sop is applicable to the Credence Pharmaceuticals for changes to the master documents.

Responsibility: All the functional Heads.

Accountability: Head – Quality Assurance.

Documentation:
Document Change Control -D083A
Revision History -D084A
Filling procedure for Document Change Control -(D083A)
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 the environment- S
The fourth digit is the alphabet and represents the year in which change takes place

Year Code
2020 – 21A
2021 – 22B
2022 – 23C

The fifth and sixth are numerical and represent running numbers.
Document Number: SOP No., or AM No., or Spec No., or 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 document 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 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: 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 (D084A)
Document Name: The document name or title of the Document shall be entered here.
Document Number: SOP No., or AM No., or 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

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 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 D084A

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