Guidelines for Pharmacovigilance Documentation Management

1) Purpose

The purpose of this SOP is to establish procedures for the management, retention, and retrieval of pharmacovigilance documentation in compliance with regulatory requirements.

2) Scope

This SOP applies to all pharmacovigilance personnel responsible for creating, maintaining, and archiving documentation, including pharmacovigilance managers, document control specialists, and compliance officers.

3) Responsibilities

The Documentation Management Team is responsible for ensuring that pharmacovigilance documents are managed according to established procedures and regulatory standards. The Pharmacovigilance (PV) Manager oversees documentation management activities to ensure completeness, accuracy, and accessibility of records.

4) Procedure

4.1 Document Creation and Formatting

1. Create pharmacovigilance documents using approved templates and formatting guidelines.
2. Ensure documents are clear, concise, and compliant with regulatory requirements.
3. Include relevant metadata such as document title, author, version number, and date of creation.

4.2 Document Review and Approval

1. Conduct a thorough review of documents by subject matter experts, regulatory affairs, and quality assurance personnel.
2. Revise documents 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 Document Distribution and Access Control

1. Distribute approved documents to relevant stakeholders, ensuring controlled access as per document security protocols.
2. Maintain a document distribution log to track dissemination and receipt.
3. Implement access controls to restrict unauthorized access and ensure confidentiality of sensitive information.

4.4 Document Retention and Archiving

1. Establish a document retention schedule based on regulatory requirements and organizational policies.
2. Archive documents in a secure and organized manner, ensuring easy retrieval and retrieval of historical records.
3. Dispose of expired or obsolete documents in accordance with document retention and destruction policies.

4.5 Document Control and Version Management

1. Maintain a master list of pharmacovigilance documents with version control to track revisions, approvals, and effective dates.
2. Ensure only the latest approved versions of documents are available for reference and use.
3. Implement change control procedures to manage document revisions and updates.

5) Abbreviations, if any

PV – Pharmacovigilance, SOP – Standard Operating Procedure

6) Documents, if any

Document templates, document distribution logs, document retention schedule, document disposal records.

7) Reference, if any

EU Good Pharmacovigilance Practices (GVP) Module VI – Management and Reporting of Adverse Reactions to Medicinal Products, FDA Guidance for Industry – Electronic Records; Electronic Signatures – Scope and Application.

8) SOP Version

Version 1.0