SOP for QPPV Role and Responsibilities

PURPOSE

This SOP describes the role and responsibilities of the QPPV and Deputy for marketed products at XXX Industries.

RESPONSIBILITY

The Company Pharmacist shall be responsible for the review, update and amendments in the Employment contract, Job description, Documentation on Qualified Person for Pharmacovigilance and the Back Up Qualified Person for Pharmacovigilance.

PROCEDURE

Qualifications of a QPPV and a deputy QPPV

Shall Possess a minimum requirement of a Bachelor’s Degree in Pharmacy, with additional certificate/diploma/fellowship or post graduate training in good pharmacovigilance practices (GVP) from institutions recognized by Pharmacy and Poisons Board.
Shall in addition receive a mandatory refresher GVP trainings facilitated by the MAH (XXX Industries) in accredited/recognized institutions by the Health Authorities. The refresher trainings should be carried out at least once in two years and evidence of the same submitted to PPB.
Have knowledge of applicable Health Authority guidelines covering safety monitoring of legislation and guidelines plus international standards for good pharmacovigilance practices.
Within the first five years of acting as QPPV, in addition to the GVP training, the occupant of this role must have completed at the least a master’s program in pharmacovigilance and pharmacoepidemiology in institutions recognized by the board and certification provided to the Health Authorities.
Demonstrate GVP knowledge in the implementation of activities stipulated in the XXX Industries Pharmacovigilance System Master File
Shall have current/valid practice license from Pharmacy and Poisons Board as the QPPV pharmacist and must be prominently displayed at XXX Industries premises.
Shall be qualified by pertinent training or experience relevant to their assigned responsibilities.

Roles and responsibilities of a QPPV and a deputy QPPV

The establishment and maintenance of the marketing authorization holder's pharmacovigilance system master file and therefore should have sufficient authority to influence the performance of the quality system and the good pharmacovigilance standards and to promote, maintain and improve compliance with the legal requirements. Hence, the QPPV should have access to the pharmacovigilance system master file (PSMF) at all times.
Having oversight over the functioning of the pharmacovigilance system in all relevant aspects including quality management system (e.g. standard operating procedures, contractual arrangements, database operations, compliance data regarding quality, completeness and timeliness of expedited reporting and submission of periodic update reports, audit reports and training of personnel in relation to pharmacovigilance).
The QPPV shall act as a single point of contact for the Board on all matters relating to the product safety and quality of their marketed products including pharmacovigilance inspections.
Preparing, reviewing and implementing company SOPs for PV activities.
The QPPV should be aware of the validation status of the adverse reaction database if applicable, including any failures that occurred during validation and the corrective actions that have been taken to address the failures. The QPPV should also be informed of significant changes that are made to the database (e.g. changes that could have an impact on pharmacovigilance activities).
The QPPV may delegate specific tasks, under supervision, to appropriately qualified and trained individuals, for example, acting as safety experts for certain products, provided that the QPPV maintains system oversight and overview of the safety profiles of all products. Such delegation should be documented.
Establishing and maintaining a system which ensures that information about all suspected adverse drug reactions/events (or spontaneous post marketing events) which are reported to the personnel of the marketing authorization holder, including to medical representatives, is collected, collated, processed and evaluated and forwarded to the Board in line with the timelines stipulated by the Board.

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Preparing and submitting the following to the Board through established channels:

Adverse Events to Medical Products and Health Technologies
Periodic Safety Update Reports and Periodic Benefit-Risk Evaluation
Reports (PSUR/PBRER)
Company-sponsored pre- and post-registration study reports
Risk Management Plans (RMPs)
Ongoing pharmacovigilance evaluation during the post-registration period.
The report should be submitted to PPB as soon as possible after the evaluation.

Ensuring that any request from the Board for additional information deemed necessary for the evaluation of the risk-benefit ratio of a marketed product, is provided to the Board fully and promptly.
Overseeing the safety profiles of the company’s marketed products and any emerging safety concerns.
Ensuring that all personnel involved in pharmacovigilance activities, which may include customer service and sales representatives etc. have their specific duties recorded in a written description and have adequate authority to carry out their responsibilities.
Ensuring that all personnel involved in pharmacovigilance activities should be aware of the principles of pharmacovigilance that affect them, and all personnel shall receive relevant training.
Ensuring that competent persons are appointed to carry out their duties and functions in their absence.
Ensuring that Qualified health care professional possessing adequate experience and education (e.g. QPPV and medical affairs staff), should be available to evaluate information in respect of potential ADEs, assesses the seriousness, expectedness and reportability of ADEs and determine if the ADE report qualifies for expedited reporting.
Ensuring that training is provided prior to implementation of new or revised procedures. Records of training should be maintained.
Have an oversight of the PMS activities of the MAHs products registered in the country.
Annual Review of the role and responsibilities of the QPPV and deputy QPPV
The roles and responsibilities of the QPPV and Deputy QPPV shall be conducted by the company pharmacist during the month of January to ensure the roles and responsibilities are up to date as per available health authority pharmacovigilance guidelines and legislations.
The Company Pharmacist shall ensure that the QPPV and Deputy QPPV have conducted an annual refresher training the through Uppsala Monitoring Centre website training modules for pharmacovigilance (https://learning.who-umc.org/home) as part of the health authority requirement.
The Company Pharmacist shall also ensure that all regulatory licences have been renewed, up to date and are valid.
The Company pharmacist shall ensure that all Local Technical Representative have an appointed local QPPV and all regulatory requirements have been fulfilled as per applicable local regulation and Safety Data Exchange Agreement/QPPV agreement.