Guidelines for Pharmacovigilance Archiving Procedures

1) Purpose

The purpose of this SOP is to outline procedures for the archiving and retention of pharmacovigilance records and documents in compliance with regulatory requirements.

2) Scope

This SOP applies to all pharmacovigilance personnel responsible for archiving and managing pharmacovigilance records, including pharmacovigilance managers, archivists, and compliance officers.

3) Responsibilities

The Archiving Team is responsible for ensuring that pharmacovigilance records are archived and retained according to regulatory guidelines and organizational policies. The Pharmacovigilance (PV) Manager oversees archiving activities to ensure the integrity, accessibility, and security of archived records.

4) Procedure

4.1 Record Identification and Selection

1. Identify pharmacovigilance records eligible for archiving based on regulatory requirements and organizational policies.
2. Verify completeness and accuracy of records before archiving.
3. Categorize records for archiving based on document type, relevance, and retention schedule.

4.2 Archiving Process

1. Prepare pharmacovigilance records for archiving by organizing documents and ensuring proper labeling.
2. Securely package archived records in suitable containers or digital formats for long-term preservation.
3. Document and log archived records in an archiving inventory or database for tracking and retrieval purposes.

4.3 Storage and Retrieval

1. Store archived records in a designated archival storage area or electronic repository with controlled access.
2. Maintain environmental conditions suitable for preserving paper-based and electronic records.
3. Establish procedures for retrieving archived records promptly upon request for audits, inspections, or legal purposes.

4.4 Retention and Disposal

1. Adhere to document retention schedules based on regulatory requirements and organizational policies.
2. Periodically review archived records for disposition eligibility and initiate disposal procedures for expired or obsolete records.
3. Document disposal activities and maintain records of record destruction in compliance with data privacy and security regulations.

4.5 Archive Maintenance and Security

1. Monitor and maintain the integrity and accessibility of archived records through regular inspections and quality checks.
2. Implement security measures to protect archived records from unauthorized access, theft, or damage.
3. Update archival procedures and technologies as needed to ensure compliance with evolving regulatory requirements.

5) Abbreviations, if any

PV – Pharmacovigilance, SOP – Standard Operating Procedure

6) Documents, if any

Archiving inventory, archiving logs, disposal records, environmental monitoring logs.

7) Reference, if any

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

8) SOP Version

Version 1.0