3. Responsibilities

• Author (Initiator): Prepares draft SOP in standard format and submits for review.
• Department Head: Reviews SOP for technical accuracy and practicality.
• QA Department: Ensures compliance with applicable regulations and internal requirements; responsible for final approval and issuance.
• QA Documentation Cell: Maintains master list and distributes controlled copies.

4. Accountability

The Head of Quality Assurance is accountable for ensuring that all SOPs are current, approved, accessible, and properly implemented across the facility.

5. Procedure

5.1 SOP Format and Numbering

1. All SOPs shall follow the standard format including:
   • Title Page: SOP title, SOP number, version, effective date, review date
   • Sections: Purpose, Scope, Responsibilities, Accountability, Procedure, Abbreviations, Documents, References, SOP Version, Approval Section, Annexures, Revision History
2. SOP numbers shall follow the format: SOP/API/XXX/YYYY, where:
   • XXX = sequential number
   • YYYY = year of issue

5.2 SOP Drafting

1. The SOP author drafts the document using the approved template (Annexure-1).
2. Information should be written in clear, concise, and instructional language.
3. The draft is submitted to the department head for technical review.

5.3 Review and Approval

1. The draft is reviewed by:
   • Department Head – for operational relevance
   • QA – for GMP compliance, clarity, and formatting
2. After review, the SOP is signed by the preparer, reviewer(s), and approver(s) using the signature format (Annexure-2).
3. Final version is forwarded to QA Documentation Cell for issuance of controlled copies.

5.4 SOP Distribution and Implementation

1. Controlled copies are issued to relevant departments by QA Documentation Cell.
2. A distribution record is maintained (Annexure-3).
3. Obsolete versions are retrieved and archived with “Obsolete” watermark.

5.5 SOP Training

1. Before implementation, QA coordinates training for relevant users.
2. Training records are maintained by the department and QA (Annexure-4).

5.6 SOP Review and Revision

1. SOPs shall be reviewed every 2 years or earlier if:
   • Regulatory guidelines change
   • Significant deviation, audit finding, or process change occurs
2. Revised SOPs shall undergo the same cycle of drafting, review, approval, and distribution.

5.7 Obsolete SOPs

1. When an SOP is superseded, the old version is stamped “Obsolete” and archived in QA for at least 5 years.
2. A list of obsolete SOPs is maintained (Annexure-5).

6. Abbreviations

• SOP: Standard Operating Procedure
• QA: Quality Assurance
• GMP: Good Manufacturing Practices
• API: Active Pharmaceutical Ingredient

7. Documents

1. SOP Template (Annexure-1)
2. SOP Review and Approval Format (Annexure-2)
3. SOP Distribution Record (Annexure-3)
4. Training Record Template (Annexure-4)
5. Obsolete SOP Log (Annexure-5)

8. References

• ICH Q10: Pharmaceutical Quality System
• WHO GMP Guidelines – Documentation Practices
• 21 CFR Part 211 – Subpart J: Records and Reports

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: SOP Template

Section	Description
Purpose	Why the SOP is needed
Scope	What is covered
Procedure	Step-by-step instructions

Annexure-2: SOP Review and Approval Format

Stage	Name	Signature	Date
Prepared	Rajesh Kumar
Reviewed	Sunita Reddy
Approved	QA Head

Annexure-3: SOP Distribution Record

Copy No.	Department	Issued By	Date
01	Production	QA Documentation	10/04/2025

Annexure-4: Training Record

Name	Department	Trained On	Trainer	Remarks
Amit Joshi	QA	11/04/2025	Training Officer	Completed

Annexure-5: Obsolete SOP Log

SOP No.	Title	Obsolete Date	Replaced By
SOP/API/090/2023	Cleaning of Vessels	01/02/2025	SOP/API/090/2025

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
01/01/2022	1.0	Initial release	New SOP	QA Head
14/04/2025	2.0	Standardized annexures, clarified numbering	Audit observation	QA Head