The Pharmacovigilance guidance document for Marketing Authorization Holders of Pharmaceutical Products stated following thing regarding Pharmacovigilance System Master file PSMF.
Content of PSMF
Module 1
1.1 Introduction
The CDSCO should make a regulatory decision regarding the safety and efficacy of pharmaceutical goods based on the expert committee’s analysis. The data that surface after the first post-licensure studies conducted by PSUR or any other PMS study will serve as the foundation for any subsequent decisions made by the licencing authority regarding the pharmaceutical product’s indications, usage, and restrictions. Additional decisions regarding the length of time that PSUR data must be submitted beyond four years may also be made using this data.
1.2 Scope
This guideline covers PvMF requirements for pharmaceutical products approved in India, regardless of the licencing authorities’ preferred method for obtaining marketing authorization.
1.3 Objective
Obtain information about deficiencies in the system, or non-compliance with the requirements. Obtain information about risks or actual failure in the conduct of specific aspects of Pv.
1.4 Contents of the PSMF
1.4.1 Pharmacovigilance Officer In-charge
1.4.2 Pharmacovigilance organization structure
1.4.2.1 MAH
The MAHs Pv hierarchy needs to be described. A concise synopsis of the company(ies) and related Pv departments involved, as well as any relationships between organisations and operational units pertinent to the performance of Pv obligations, should be included in the description.
1.4.2.2 Contract Research Organization
1.4.3 Sources of safety data
1.4.4 Pharmacovigilance Processes
1.4.4.1 Description
A description and flow-diagram of the entire Pv process, data handling, records and archives of Pv performance, covering the following aspects shall be included in the PVMF
1.4.4.2 SOP should include the following:
1.4.4.3 Computerized systems and database
PvMF should specify the location, capabilities, and operational accountability of computerised systems and databases used for the collection, reporting, and receipt of safety-related data. A description of the testing process, backup plans, and the status of computer system functionality validation with change control, if applicable, should also be included. Excel spreadsheets can be used by the MAH for data collection, tracking, and recording.
1.4.4.4 QMS in Pharmacovigilance
1.4.5 Pharmacovigilance system performance
