Guidelines for Pharmacovigilance SOP Management

1) Purpose

The purpose of this SOP is to establish procedures for the development, review, approval, and management of Standard Operating Procedures (SOPs) within the pharmacovigilance department.

2) Scope

This SOP applies to all pharmacovigilance personnel involved in the creation, implementation, and maintenance of SOPs, including pharmacovigilance managers, quality assurance specialists, and compliance officers.

3) Responsibilities

The SOP Management Team is responsible for ensuring that SOPs are developed, reviewed, approved, and maintained in compliance with regulatory requirements and organizational standards. The Pharmacovigilance (PV) Manager oversees SOP management activities to ensure consistency, clarity, and effectiveness of procedures within the department.

4) Procedure

4.1 SOP Development

1. Identify the need for a new SOP or revision based on regulatory updates, process changes, or quality improvement initiatives.
2. Assign a SOP owner responsible for drafting the SOP content and obtaining input from relevant stakeholders.
3. Develop SOP content using standardized templates and formatting guidelines.

4.2 SOP Review and Approval

1. Conduct a thorough review of the draft SOP by subject matter experts, regulatory affairs, and quality assurance personnel.
2. Revise SOP based on feedback and ensure alignment with regulatory requirements and internal policies.
3. Obtain approval from designated authorities, such as the Pharmacovigilance Head or Quality Assurance Director.

4.3 SOP Implementation and Training

1. Communicate the approved SOP to all relevant personnel through training sessions or dissemination of SOP documents.
2. Ensure understanding and adherence to SOP procedures through competency assessments and periodic training updates.
3. Monitor compliance with SOP requirements and address any deviations promptly.

4.4 SOP Revision and Version Control

1. Establish a formal process for reviewing and revising SOPs as necessary to reflect changes in regulations, processes, or organizational requirements.
2. Maintain a master list of SOPs with version control to track revisions, approvals, and effective dates.
3. Archive obsolete SOP versions while retaining historical records for audit and reference purposes.

4.5 SOP Documentation and Records Management

1. Maintain accurate and up-to-date documentation of all SOPs, including SOP manuals, associated forms, and supporting documents.
2. Ensure SOP documents are stored securely and accessible to authorized personnel only.
3. Perform regular audits of SOP documentation to verify completeness, accuracy, and compliance with regulatory standards.

5) Abbreviations, if any

PV – Pharmacovigilance, SOP – Standard Operating Procedure

6) Documents, if any

SOP templates, SOP manuals, SOP revision logs, SOP training records.

7) Reference, if any

EU Good Pharmacovigilance Practices (GVP) Module IV – Pharmacovigilance Quality Systems, FDA Guidance for Industry – Quality Systems Approach to Pharmaceutical CGMP Regulations.

8) SOP Version

Version 1.0