OBJECTIVE:

• To define the procedure for preparation, approval, maintenance, and control of the Pharmacovigilance Master File (PSMF) in accordance with World Health Organization (WHO) guidelines, European Union Good Pharmacovigilance Practices (EU-GVP) Module II, and applicable national PV regulations.

SCOPE:

• • This SOP applies to all activities related to creating, updating, managing, and maintaining the PSMF for all marketed products of the company, including products under World Health Organization Prequalification (WHO-PQ), and products registered in countries requiring a PSMF or equivalent document.

RESPONSIBILITIES:

Qualified Person for Pharmacovigilance (QPPV):

• Ensure the PSMF is accurate, complete, and continuously updated.
• Approve the PSMF and major revisions.
• Maintain oversight of content provided by all departments.
• Ensure availability of PSMF to regulatory authorities upon request.
• Ensure PSMF reflects the real functioning of the PV system at all times.
• Prepare, draft, and update PSMF modules.
• Collect and verify PSMF inputs from RA, QA, Production, QC, Medical.
• Maintain PSMF Logs (version log, update log).
• Ensure timely updates to Annexures and relevant sections.
• Coordinate with back up QPPV and cross functional teams (CFTs) during audits and inspections.

Regulatory Affairs (RA):

• Provide country-specific regulatory PV requirements.
• Maintain list of product registrations and safety reporting timelines.

Quality Assurance (QA):

• Provide QA system elements relevant to PV (training compliance, deviations, CAPA).
• Ensure PSMF documents are archived as per QMS requirements.

DEFINATIONS:

• Pharmacovigilance Master File (PSMF): A detailed, complete document describing the PV system used by the company for its products.
•  Qualified Person for Pharmacovigilance (QPPV): Person with legal responsibility and oversight of the PV system.
•  Individual Case Safety Report (ICSR): Report of an individual patient’s adverse experience.
•  Periodic Safety Update Report (PSUR): Regular report summarizing safety data.
•  Periodic Benefit–Risk Evaluation Report (PBRER): Updated evaluation of benefit–risk balance of a product.

 PROCEDURE:

Structure of the PSMF:

• The PSMF shall contain the following sections as per EU-GVP Module II:
• • • • Main Body:
        • Organizational structure of PV system
        • Roles & responsibilities (including QPPV and deputy)
        • System description
        • Computerized systems used for PV
        • Sources of safety data
        • Processes for ICSRs
        • Processes for Risk Management Plan (RMP)
        • Periodic Safety Update Report (PSUR)
        • Periodic Benefit–Risk Evaluation Report (PBRER)
        • Signal management system
        • Quality system description
        • Performance indicators of the PV system
        • Annexures such as Product list, QPPV and Back up QPPV JD and contact details, Organization chart, List of SOPs, List of partners & Safety Data Exchange Agreements (SDEA), Training records summary, PV audit schedule summary, List of computer systems and validation status, Complaint and AE reporting forms, Risk-minimization measures summary

 Preparation of the PSMF:

• Back up QPPV drafts the initial PSMF based on current PV system.
• QPPV reviews the draft for accuracy and completeness.
• Pharmacovigilance Head Approves PSMF.
• The approved version is stored in a controlled system with restricted access.
• PSMF must always reflect the actual functioning PV system, not planned or theoretical processes.

Updating the PSMF:

• Once in three years.
• The PSMF shall be updated when any of the following change:
  • QPPV or Deputy QPPV details
  • Changes in PV organizational structure
  • New product authorizations or withdrawals
  • Changes in safety database or IT systems
  • New or revised Risk Management Plan (RMP)
  • Updated processes, SOPs, or quality system elements. Periodic review of processes, SOPs, or quality system elements shall not be eligible for PSMF updation.
  • Updated list of partners or Safety Data Exchange Agreements (SDEA).
  • Changes in reporting timelines or regulatory safety requirements.
  • Changes in PV audit outcomes affecting system performance
  • Any significant safety issue requiring regulatory interaction
  • Annexes shall be updated on an ongoing basis.

 Version Control:

• The PSMF shall contain a version control page including:
• • • Version number
    • Effective date
    • Nature of change
    • Section revised
    • Approved by QPPV
    • Minor updates (annex updates) may follow simplified approval process.
    • Major updates require full approval per document control SOP.

 Archiving and Retention:

• PSMF versions shall be archived for minimum 10 years after last product authorization, or as per local regulation.
• PV department ensures secure storage with controlled access.
• Retrieval shall be possible within 24 hours for regulatory inspection.

Access Control & Confidentiality:

• Access to PSMF is restricted to QPPV, PV Manager, and authorized personnel.
•  External sharing is permitted only after QPPV approval.
•  Confidential information must be protected as per company Confidentiality SOP.

 Availability During Audit / Inspection:

• QPPV / Back up QPPV or Head PV shall present the PSMF to regulatory authorities upon request.
• PSMF must be updated and inspection-ready at all times.
• Copies provided during inspection shall be marked “Controlled Copy”.

Compliance Monitoring:

• QPPV monitors compliance indicators such as:
• • • Individual Case Safety Report (ICSR) submission timelines
    • Literature screening compliance
    • Signal detection cycle completion
    • Training compliance
    • PV Deviation trends
    • Corrective and Preventive Actions (CAPA) are initiated through QMS if gaps are identified.

 Training:

• All PV personnel must be trained on this SOP before implementation.
• Refresher training as per QMS Training SOP.

 Deviation:

• All deviations from this SOP shall be handled through the company Deviation & Corrective and Preventive Action (CAPA) SOP.

Archiving and Retention:

• Retain PSMF versions for minimum 5 years after last product authorization or per local regulations.
•  Archive in secure, access-controlled system.

PSMF document Numbering Pattern:

• PSMF / XXX – YY Where:
  • • PSMF = Document category (Pharmacovigilance System Master File)
    • XXX = Sequential document number (001, 002, 003…)
    • YY = Version number (00, 01, 02…)
    • PSMF/001 – 00 = Initial PSMF main file, version 00

REFERENCES:

• WHO Technical Report Series (TRS) – PV guidance
•  EU Good Pharmacovigilance Practices (GVP)
• Company QMS SOPs (Document Control, Training, Audit, Risk Management, Deviation & CAPA)

 RECORDS:

 REVISION HISTORY.