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 |