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 – 21 | A |
2021 – 22 | B |
2022 – 23 | C |
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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Naresh Bhakar is the Founder and Author at Pharmaguddu.com, bringing his extensive expertise in the field of pharmaceuticals to readers worldwide. He has experience in Pharma manufacturing and has worked with top Pharmaceuticals. He has rich knowledge and provides valuable insights and data through his articles and content on Pharmaguddu.com. For further inquiries or collaborations, please don’t hesitate to reach out via email at [email protected].