electronic controlled copies of SOPs distributed by the Quality Assurance (QA) department to user departments within the API manufacturing unit. It includes issuance, stamping, acknowledgment, revision control, and retrieval processes.

3. Responsibilities

• QA Documentation Officer: Maintains master and controlled copies, logs issuance, retrieves obsolete copies, and ensures document control compliance.
• Department Heads: Ensure that only current versions of SOPs are available at points of use and obsolete versions are promptly returned.
• QA Manager: Approves issuance and ensures periodic review of document control system.

4. Accountability

The Head of Quality Assurance is accountable for ensuring only approved, current, and authorized SOP versions are in circulation and use throughout the facility.

5. Procedure

5.1 Classification of Copies

1. Master Copy: The original signed version stored under QA control (Annexure-1).
2. Controlled Copy: A QA-authorized and stamped copy issued for use in respective departments (Annexure-2).
3. Uncontrolled Copy: Any copy printed or shared for training or reference without issuance tracking and QA stamp; these must be marked “Uncontrolled.”

5.2 Issuance of Controlled Copies

1. QA shall print copies of the SOP upon approval using the final signed and dated Master Copy.
2. Each copy shall be:
   • Stamped as “CONTROLLED COPY” in red ink
   • Sequentially numbered as CC-01, CC-02, etc.
   • Signed and dated by the QA Documentation Officer
3. Details of each issued copy shall be logged in the Controlled Copy Issuance Register (Annexure-3).

5.3 Distribution and Acknowledgment

1. Controlled copies are distributed to departments against acknowledgment in the SOP Acknowledgment Form (Annexure-4).
2. The receiving department must:
   • Verify the copy and confirm receipt
   • Ensure filing in designated SOP file holder
   • Replace previous versions immediately

5.4 Retrieval of Obsolete SOPs

1. Upon revision of an SOP:
   • QA issues the new controlled version
   • The old version is withdrawn and marked “OBSOLETE” in red
2. Obsolete copies are recorded in the Obsolete SOP Control Log (Annexure-5) and stored in a dedicated QA archive file marked “RETIRED SOPs.”

5.5 Access and Storage

1. Controlled copies must be stored in a central, easily accessible location within the department’s documentation area.
2. Electronic SOPs accessed via DMS must follow the same control rules with system-based user access rights.

5.6 Audit and Reconciliation

1. QA shall conduct quarterly SOP audits across departments using the SOP Reconciliation Checklist (Annexure-6) to ensure:
   • Only current versions are in use
   • No handwritten changes exist
   • Copies are legible, intact, and filed properly

6. Abbreviations

• QA: Quality Assurance
• SOP: Standard Operating Procedure
• CC: Controlled Copy
• DMS: Document Management System

7. Documents

1. Master SOP Register (Annexure-1)
2. Controlled Copy Distribution Record (Annexure-2)
3. Controlled Copy Issuance Register (Annexure-3)
4. SOP Acknowledgment Form (Annexure-4)
5. Obsolete SOP Control Log (Annexure-5)
6. SOP Reconciliation Checklist (Annexure-6)

8. References

• ICH Q10 – Pharmaceutical Quality System
• WHO TRS 986 Annex 2 – Good Documentation Practices
• 21 CFR Part 211.100 – Written Procedures
• EU GMP Chapter 4 – Documentation

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Master SOP Register

SOP No.	Title	Version	Effective Date	Status
SOP/API/025/2025	Granulation Procedure	V2.0	01/03/2025	Active

Annexure-2: Controlled Copy Distribution Record

SOP No.	CC No.	Issued To	Department	Date
SOP/API/025/2025	CC-03	Rajesh Kumar	Production	02/03/2025

Annexure-3: Controlled Copy Issuance Register

SOP No.	Copy No.	Issued To	Issued By	Date
SOP/API/010/2025	CC-01	QC Lab	QA Officer	05/04/2025

Annexure-4: SOP Acknowledgment Form

SOP No.	Version	Receiver Name	Signature	Date
SOP/API/010/2025	2.0	Sunita Reddy		05/04/2025

Annexure-5: Obsolete SOP Control Log

SOP No.	Version	Obsoleted On	Withdrawn From	Archived By
SOP/API/010/2022	V1.0	05/04/2025	QA Office	QA Officer

Annexure-6: SOP Reconciliation Checklist

Department	SOP Title	Version	Compliant	Remarks
Production	Weighing of API	V2.0	Yes	Filed correctly

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
01/01/2022	1.0	Initial Version	New SOP Creation	QA Head
14/04/2025	2.0	Added reconciliation and acknowledgment process	Internal Audit Recommendation	QA Head