Procedure for Preparing and Reviewing Standard Operating Procedures

Department	Quality Assurance (QA)/Quality Control (QC)/Production
SOP No.	SOP/Ointment/161
Supersedes	V 1.0
Page No.	Page X of Y
Issue Date	[Insert Issue Date]
Effective Date	[Insert Effective Date]
Review Date	[Insert Review Date]

1. Purpose

The purpose of this Standard Operating Procedure (SOP) is to establish a systematic approach for preparing, reviewing, approving, and maintaining SOPs within pharmaceutical manufacturing. SOPs ensure standardization of processes, regulatory compliance, and effective training of personnel.

2. Scope

This SOP applies to personnel in the Quality Assurance (QA), Quality Control (QC), Production, and other relevant departments responsible for drafting, reviewing, and maintaining SOPs.

3. Responsibilities

• Departmental Heads: Identify the need for new or revised SOPs and assign authors.
• SOP Author: Drafts the SOP following standard templates and guidelines.
• QA Officer: Reviews the SOP for compliance and clarity.
• QA Manager: Approves the final SOP for implementation.
• Training Coordinator: Ensures that relevant staff members are trained on new or revised SOPs.

4. Accountability

The QA Manager is accountable for ensuring that all SOPs are properly prepared, reviewed, and maintained in compliance with GMP, FDA, ICH, and WHO regulations.

5. Procedure

5.1 SOP Format and Structure

All SOPs must follow a standard format, which includes:

• Title: Clearly defines the purpose of the SOP.
• Version Number: Specifies the revision history.
• Scope: Defines the applicability of the SOP.
• Responsibilities: Identifies personnel responsible for execution.
• Procedure: Provides a step-by-step guide for performing the process.
• References: Lists regulatory and internal guidelines followed.
• Annexures: Includes templates, logs, or additional reference documents.

5.2 SOP Preparation

• The SOP author must draft the SOP using the **standard template**.
• Each SOP must be assigned a **unique identification number**.
• All procedures must be described in **clear and concise language**.
• The draft SOP must be **submitted to the department head for initial review**.

5.3 SOP Review and Approval Process

• The **QA team** must review the SOP for:
  • Compliance with GMP and regulatory standards.
  • Accuracy and completeness of instructions.
  • Consistency with existing procedures.
• The **QA Manager** must approve the SOP before implementation.
• The approved SOP must be:
  • Signed and dated by all relevant stakeholders.
  • Uploaded to the **document management system (DMS).**
  • Distributed to all applicable departments.

5.4 SOP Implementation and Training

• All employees affected by the SOP must receive **formal training**.
• A **Training Record** must be maintained for each employee trained.
• The training coordinator must conduct **assessments** to ensure comprehension.

5.5 SOP Revision and Control

• SOPs must be reviewed **every two years** or when regulatory updates occur.
• Any revision must be documented in the **SOP Revision History Log.**
• Obsolete SOPs must be marked as **”Superseded”** and archived.

5.6 Archiving and Retention of SOPs

• All approved SOPs must be stored in a **secured archive.**
• Retention period:
  • Active SOPs – **Minimum 5 years.**
  • Superseded SOPs – **Minimum 10 years.**

6. Abbreviations

• GMP – Good Manufacturing Practices
• QA – Quality Assurance
• QC – Quality Control
• DMS – Document Management System
• FDA – Food and Drug Administration
• ICH – International Council for Harmonisation

7. Documents

• SOP Preparation Checklist (Annexure-1)
• SOP Revision History Log (Annexure-2)

8. References

• ICH Q10 – Pharmaceutical Quality System
• WHO Guidelines on SOP Management
• US FDA Guidance on Document Control

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 Preparation Checklist

Checklist Item	Verified By	Date
Title and Version Number Assigned	John Doe	02/02/2025
Procedure Section Completed	Jane Smith	03/02/2025

Annexure-2: SOP Revision History Log

Revision Date	Revision No.	Details	Reason	Approved By
02/02/2025	2.0	Expanded Procedure	Improved SOP Documentation	QA Head

12. Revision History

Revision Date	Revision No.	Details	Reason	Approved By
02/02/2025	2.0	Expanded Review Section	Improved Compliance	QA Head