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BASIC Training: PSMF, compliance dubbed
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🔎 Introduction to Pharmacovigilance System Master File (PSMF)
The Pharmacovigilance System Master File (PSMF) is a key document in the realm of pharmacovigilance, mandated by European legislation to ensure the safety of medicinal products. The PSMF provides a comprehensive description of the pharmacovigilance system used by a Marketing Authorisation Holder (MAH). It outlines the structures, processes, and compliance measures in place to monitor and manage the safety of medicinal products.
Key Aspects of the PSMF
🔎 Definition and Purpose:
The PSMF describes the pharmacovigilance system used for one or more medicinal products of the MAH. It supports documentation of compliance with legal requirements and aids in audits and inspections.
🔎 Content and Structure:
The PSMF includes sections on the qualified person responsible for pharmacovigilance (QPPV), the organisational structure, sources of safety data, computerised systems and databases, and detailed pharmacovigilance processes.
🔎 Location and Accessibility:
The PSMF must be located within the EU, either at the site where the main pharmacovigilance activities are performed or where the QPPV operates. It must be available in electronic format or as a clearly arranged printed copy, and accessible to competent authorities upon request within seven days.
🔎 Maintenance and Updates:
The PSMF should be maintained in a current and accessible state. It includes a logbook for recording changes, updates, and corrective actions until these are fully implemented and verified.
🔎 Oversight and Compliance:
The PSMF ensures proper oversight by the QPPV and documents the performance of the pharmacovigilance system, including any deviations and their management. It also contains targets for performance and quality system details.
Understanding the PSMF is crucial for those involved in pharmacovigilance to ensure that their systems meet regulatory requirements and effectively safeguard public health.
The Pharmacovigilance System Master File (PSMF) is a key document in the realm of pharmacovigilance, mandated by European legislation to ensure the safety of medicinal products. The PSMF provides a comprehensive description of the pharmacovigilance system used by a Marketing Authorisation Holder (MAH). It outlines the structures, processes, and compliance measures in place to monitor and manage the safety of medicinal products.
Key Aspects of the PSMF
🔎 Definition and Purpose:
The PSMF describes the pharmacovigilance system used for one or more medicinal products of the MAH. It supports documentation of compliance with legal requirements and aids in audits and inspections.
🔎 Content and Structure:
The PSMF includes sections on the qualified person responsible for pharmacovigilance (QPPV), the organisational structure, sources of safety data, computerised systems and databases, and detailed pharmacovigilance processes.
🔎 Location and Accessibility:
The PSMF must be located within the EU, either at the site where the main pharmacovigilance activities are performed or where the QPPV operates. It must be available in electronic format or as a clearly arranged printed copy, and accessible to competent authorities upon request within seven days.
🔎 Maintenance and Updates:
The PSMF should be maintained in a current and accessible state. It includes a logbook for recording changes, updates, and corrective actions until these are fully implemented and verified.
🔎 Oversight and Compliance:
The PSMF ensures proper oversight by the QPPV and documents the performance of the pharmacovigilance system, including any deviations and their management. It also contains targets for performance and quality system details.
Understanding the PSMF is crucial for those involved in pharmacovigilance to ensure that their systems meet regulatory requirements and effectively safeguard public health.