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This Standard Operating Procedure (SOP) sets how Pharmaceuticals initiates, reviews, approves and records changes to master documents. The departmental Head fills the Document Change Control form (Example format number: D083A) and submits it to the Head Quality Assurance (QA). QA reviews the proposal and circulates it to the related departments when needed. QA then approves or rejects it, and the revisions are recorded in Revision History.
Objective: This SOP to initiate, incorporate, approve and record changes to the master documents is a procedure that defines how Pharmaceuticals handles such changes. It uses the Document Change Control form and the Revision History form. Its objective is 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.
Documentation: Two forms are used in this procedure, change request form, and revision log. Both forms are completed in line with Good Documentation Practices.
- Document Change Control (DCC)
- Revision History
Filling procedure for Document Change Control
DCC No: Enter the document change control number (DCC No.) here. Allot it using the following guidelines.
Document change control is typically a 6-character code -DCAYNN, four letters followed by two digits. The format varies by manufacturer. In the pattern, DC are the fixed letters, A stands for the department letter, Y stands for the year letter and NN is the running number. Each position is called a “digit” in the points below, whether it is a letter or a number.
- The first and second digit are alphabets and represent the document change control.
- The third digit is the alphabet and represents the department.
Department codes:
- 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 that represents the year in which the change takes place.
| Year | Code |
| 2022 – 23 | A |
| 2023 – 24 | B |
| 2025 – 26 | 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 of the existing document text that is going to change shall be entered here.
Details of revision–Proposed changes: The details of proposed changes shall be entered here.
Reasons that warranted the change: Enter the reasons that demand the proposed changes here.
Changes initiated by: The initiator signs here, as the person who is initiating the change.
Date: The initiator puts the date here.
HOD of initiating Department: The HOD of the initiating department signs here.
Date: The HOD of the initiating department dates this entry.
Regulatory filing requirements: Enter the regulatory filing requirements identified here.
Changes Approved/Rejected/Circulated: When the change is approved, strike off Rejected and Circulated (or “Approved” stamp). When the change is rejected, strike off Approved and Circulated (or “rejected” stamp). When the change is circulated, strike off Approved and Rejected (or “circulated” stamp).
HOD Quality Assurance: The Head QA (the HOD of quality assurance) signs here.
Date: The HOD of quality assurance puts the date here.
Departments: The names of the departments shall be entered in this column.
Comments: The 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 the change is approved, strike off Rejected. When the change is rejected, strike off Approved.
Filling procedure for Revision History.
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: The effective date of the document shall be entered here.
Reasons for revision: The reasons for revision shall be entered here.
Procedure:
Reasons for change: A master document may be changed for any of the following reasons:
- 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: The change starts with a new document and its submission to QA.
- Prepare a new document as per the changed requirement.
- The functional Head reviews the document, fills in the Document Change Control and submits it to the Head QA.
Review and Approval: QA reviews every proposal, and the route of approval depends on whether the document applies to one department or to several. Schedule M requires documents to be changed under a controlled, approved and dated procedure, which this SOP provides for master documents. The change control process is followed for each proposal.
- 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. International Council for Harmonisation (ICH) Q10 expects changes to be evaluated and approved by the quality unit before implementation, and QA applies that expectation here.
- If the document applies only within the initiating department, QA, acting through the Head QA, shall approve or reject the proposal.
- If the document applies to more than one department, QA shall circulate the proposed document to the related departments for comments.
- If the related departments raise no objections, QA shall approve the document.
- If the related departments raise objections, QA shall call 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. The printed copies of the master document carry the stamps and colours defined for each copy type.
- Revision history is maintained in the revision history document D084A. Under WHO GMP (TRS 986 Annex 2), document changes are recorded so that the revision history of each document can be traced.
Frequently Asked Questions
The departmental Head fills the Document Change Control form after reviewing the new document. The functional Head then submits the completed form to the Head QA. The new document is prepared first, as per the changed requirement, and only then is the form completed and submitted for review.
A master document can be changed for five reasons: a change in operating procedures, a change in raw material, intermediate, in-process, packing material or finished product specifications and test procedures, a change in process, a change in compendial and regulatory requirements, or improvement of the existing master documents.
QA, acting through the Head QA, approves or rejects the change proposal. For a document used only within the initiating department, QA decides directly. For a document used by several departments, QA first circulates it for comments, and then approves it if there are no objections. If objections are raised, QA decides after a meeting with the related departmental personnel.
Regulatory Affairs must concur before the document is approved whenever the change involves customers or regulatory requirements. This concurrence is part of the review stage, so that QA approves the document only after Regulatory Affairs has agreed. Other changes follow the normal QA review and approval route.
Revisions are recorded in the revision history document. The form carries the document name, the document number, the effective date and the reasons for revision. Each entry is completed by entering these details, so that the history of every master document is maintained in one place under this procedure.
References
- Schedule M, CDSCO, Drugs Rules, 1945
- WHO GMP, World Health Organization
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