PURPOSE
This SOP outlines the process in Pharmacovigilance Key Performance Indicators where XXX Industries will follow to design and produce metrics, monitor the compliance and improve the Pharmacovigilance system.
RESPONSIBILITY
The Qualified Person for Pharmacovigilance shall be responsible for the creation of Key Performance Indicator Metric at XXX Industries Ltd. Department Heads shall be responsible for co-ordinating training and implementation by staff and workers in their departments.
Introduction
Pharmacovigilance Key Performance Indicator (PV KPI’s) are a set of quantifiable measures that XXX Industries uses to gauge its performance over time. These quantifiable measures can be used to indicate how well a pharmacovigilance system is performing and whether the system is continually improving.
The demands on a Pharmacovigilance system vary depending on the number of products concerned, the nature of the products and the life cycle, and regulatory demands placed on the products.
Beyond meeting regulatory requirements, establishing a Key Performance Indicator system enables XXX Industries pharmacovigilance department to assess the health of its pharmacovigilance systems, verify compliance with regulatory pharmacovigilance requirements, keep an ongoing oversight of delegated responsibilities from vendors and partners and be prepared for audits and inspections.
Key Performance Indicators
- Structural Indicators measure systems and physical infrastructures. These indicators provide an assessment of current Pharmacovigilance documentation and resource compliance with regulatory Pharmacovigilance expectations and requirements. e.g. Existence of Company PV SOP that reflect current practice, current GVP requirements and as documented in the PSMF. Process Indicators measure how the system works. These provide insight into what extent the PV System is being implemented as planned e.g. SOP/Safety Data Exchange Agreement/PSMF compliance.
- Outcome Indicators measure final product of the inputs made into PV activities.
- These provide an overall measure of the level of risk control (patient safety) that has been achieved with the PV system in place. Examples of these indicators would be; number of audit findings, number of for safety updates to patient information leaflet, percentage compliance with safety data reporting timelines.
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The Metrices for Key Performance Indicators at XXX Industries Limited include;
- ICSRs Reporting to Health Authorities: 7-day and 15-day reports submission timeliness and quality of ICSRs.
- Periodic Report Submission to Health Authorities: Timeliness and quality of reports.
- CAPAs from Audit and Inspection findings, Deviations: Ensure CAPAs and Deviations are monitored until closure with a system to raise signals to prevent non-compliance with agreed plans.
- Signal Detection systems: Ensure signal detection activities are being performed regularly, consistent with the requirements defined by company SOPs.
- Risk Management Plans: Compliance with submission due dates, adherence to commitments and quality of documents.
- Safety Labelling Updates: Ensure new safety information is implemented in a diligent way from signal detection or competent authority assessment (PSUR Assessments, etc.), through to CCDS updates and finally Local Product Information changes.
PROCEDURE
ICSRs Reporting to Health Authorities
Weekly Operations
- The QPPV shall reconcile with the backup QPPV on the total number of Adverse Events and Product Quality complaint received during the week. The Operation shall be carried out Tuesday of every week.
- The accuracy and timeliness of reporting of the AEPQC shall be recorded as per annexure1.
- Any deviations as per the procedures on processing of adverse event and of product quality complaint shall be handled as per the standard procedure on deviation management.
Monthly Operations
- The QPPV/Back Up QPPV shall reconcile with the all the vendors and XXX Industries employees on the total number of Adverse Events and Product Quality complaint received during the month. The Operation shall be carried out on the first five days of every month.
- The accuracy and timeliness of reporting of the AEPQC shall be recorded as per annexure 2.
- Any deviations as per the procedures on processing of adverse event and processing of product complaint shall be handled as per the standard procedure on deviation management.
- The QPPV or Back Up QPPV shall present a reconciliation of AEPQC received internally through XXX Industries Employee and the vendors during a particular month to the management meeting on the last Friday of every month.
Periodic Report Submission to Health Authorities
Monthly Operations
- The QPPV/Back Up QPPV shall prepare a listing on the number of Aggregate reports submitted to the Health Authority. The accuracy and timeliness of Health Authorities reporting shall be recorded as per annexure 2.
- Any deviations as per the procedures on processing of handling aggregate reports shall be handled as per the standard procedure on deviation management.
- The QPPV or Back Up QPPV shall present the report on monthly aggregate report submission to the Health Authority during a particular month to the management meeting on the last Friday of every month.
CAPAs from Audit and Inspection findings, Deviations
Deviations
- The QPPV/Back Up QPPV shall within 48 hours inform the validation officer of any deviation that arise from the Pharmacovigilance department.
- The QPPV/Back Up QPPV shall within the timelines stipulated in the deviation management SOP handle the deviation.
- The QPPV or Back Up QPPV shall present a monthly deviation report during a particular month to the management meeting on the last Friday of every month.
CAPAs from Audit and Inspection
- The QPPV/Back Up QPPV shall take lead in handling all CAPAs from Audits and Inspections as per the standard operating procedure on handling CAPAs in pharmacovigilance.
- The QPPV or Back Up QPPV shall present a report on the status of CAPAs from pharmacovigilance audits and inspection during a particular month to the management meeting on the last Friday of every month.
Signal Detection systems
- XXX Industries shall carry out regular signal detection as per standard operating procedure on Signal Detection and Risk Management.
- The QPPV/Back Up QPPV shall on a monthly basis submit a summary report as per annexure 3 of identified safety signal reports as a result of XXX Industries products during the month and the signal management pharmacovigilance activity status associated with the products.
Risk Management Plans
Monthly Operations
- The QPPV/Back Up QPPV shall prepare a listing on the number of Risk Management Plans submitted to the Health Authority. The accuracy and timeliness of Health Authorities reporting shall be recorded as per annexure 4.
- Any deviations as per the procedures on processing of handling aggregate reports shall be handled as per the standard procedure on deviation management.
- The QPPV or Back Up QPPV shall present the report on monthly Risk Management Plans submission to the Health Authority during a particular month to the management meeting on the last Friday of every month.
Safety Labelling Updates
- The QPPV/Back up QPPV shall conduct a monthly screening of XXX Industries Limited products that require safety labelling updates.
- Whenever updates are required, the QPPV/Back Up QPPV shall initiate the changes as per the change control standard operating procedure and inform the management meeting for a final decision on the label changes on the last Friday of every month.
ANNEXURE
Annexure I: New Employee Induction Form
ABBREVIATIONS
QPPV: Qualified Person for Pharmacovigilance
CAPA: Corrective And Preventive Action
PV: Pharmacovigilance
ICSR: Individual Case Safety Report
KPIs: Key Performance Indicators
PSUR: Periodic Safety Update Safety report
AEPQC: Adverse Events Product Quality Complaints
CCDS: Company Core Data Sheet
REVISION HISTORY
Nil
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