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