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A challenge for Marketing Authorization Holders
The development of QMS is very challenging for those companies that, due to their business, are “only” a MAH and act on the market as commercial companies that have their product manufactured by third parties. In fact, as the manufacturer must comply with Good Manufacturing Practices, they are more confident with a Quality Management System (QMS) structure, SOP (Standard Operating Procedure) management, good documentation practices, and data integrity principles; instead, the “commercial” companies are not confident with these kinds of activities and often do not have inside their organization a Quality Assurance role or, if they do, it is not a full time position within the company.
With the new regulations and guidelines, quality has become a core of the pharmacovigilance system and companies need to find resources to be dedicated to PV QMS management.
Our goal with QV Hub
Based on its experience with customers, PQE Group has developed a Veterinary Pharmacovigilance Quality Management System, focused on veterinary companies’ needs and requirements. PQE Group’s Veterinary Pharmacovigilance QMS, QV Hub, is the framework of policies, procedures, and processes that are necessary to ensure that the activities relating to the management of the suspected Adverse Events and to the detection, assessment, understanding, and evaluation of the signals related to an Adverse Reaction are handled in compliance with the applicable laws and guidelines. QV Hub is structured in order to let the MAH use PQE Group’s services in the most flexible way; each SOP can be activated and used independently from all the others in order to manage a particular task that is outsourced, or, alternatively, the MAH’s can request it be applied in its PV system as a group or the whole QV Hub’s SOP system, based on their needs.
The base for the good working of the QV Hub system is the definition of a detailed pharmacovigilance agreement where the specific procedural aspects, deadlines, and metrics indicators are agreed upon to measure the system’s effectiveness.
How is PQE Group’s Veterinary Pharmacovigilance QMS structured?
As PQE Group can act on behalf of its clients on the market, both as MAH and as service provider, the QMS covers all the pharmacovigilance tasks, activities, and related quality assurance activities managed through 30 dedicated PV SOPs and almost 10 Quality Assurance SOPs applicable to PV processes. As said, the SOP system is designed to permit the customer to outsource to PQE Group a small part of PV activities or the entire system. Going into greater detail, a MAH can outsource to PQE Group the complete SAE report management from the receipt through the collection, collation, and transmission to EudraVigilance Veterinary, or outsource only part of the process, for example EVVet transmission; in the same way, through its QMS SOPs, PQE Group can perform a complete signal management or only the detection.
A sustainable PV system
The QMS has been designed and structured in order to be more sustainable for the MAH. In fact, a Document Management System is in place that permits the complete digitalization of SOPs without the use of paper; the archive of the documentation is thought to be completely digital in the customer server or PQE Group’s server, with specific SOPs for its management, respecting data integrity principles. Furthermore, all documentation generated does not require a handmade signature, minimizing data integrity compliance risks, but can be signed electronically by all the persons involved in the processes, inside or outside the organization. At the same time, as most of the activities can be performed remotely, we can say that the system will not impact the resources and documentation archive organization.
QV Hub structure
Within PQE Group’s Veterinary PV System is a SOP that has been developed that is applicable both to big companies with a large number of cases to be managed but also to small companies with smaller resources and requirements. The details agreed in the PVAs enable PQE Group to exploit its system flexibility and generate ad-hoc PV processes, with controlled and fixed costs. Risk management is the base of this PV system; a continuous risk evaluation process permits the system to be reviewed and continuously improved to stay in compliance with regulations, guidelines, and MAHs’ needs.
Following the PV process flow, PQE Group has also developed a SOP system that permits us to provide the following service:
- SAE report management: Seven SOPs for the SAE report management from receipt to the transmission to EVVet;
- Signal Management: Four dedicated SOPs from the detection to the evaluation of the benefit-risk ratio;
- Literature monitoring: One SOP for literature monitoring, applicable both for SAE research and signal evaluation;
- QPPV/dQPPV roles: Based on SOPs for the QPPV role, EMA account roles, back-up activities, and 24/7 availability;
- PV Communication: Based on a SOP for the development of the overarching communication plan and topic-specific communication plans;
- Veterinary Assessment: A specific SOP that describes how the veterinary medical assessment is performed on the SAE report, signals to be evaluated, and benefit-risk balance to be re-evaluated. In addition, the coding of the cases using VeDDRA terms is ruled by a specific SOP available to the QPPV, safety officers, and veterinarians.
A Quality Control (QC) SOP is in place to guarantee the review of all the SAEs transmitted to EVVet and for the review of the signal under management.
To support PV activities, specific Quality Assurance SOPs are in place as part of the QMS; PV Quality Assurance SOPs for the entire system can be activated all together in case of system outsourcing, or as a single/group in order to support the customer with specific PV QA issues.
These PV Quality Assurance SOPs include the following processes:
- Pharmacovigilance training for customer personnel
- Management of the PSMF
- Management of the Pharmacovigilance Agreements
- Performance of the PV System Periodic Review
- Management of proper key performance indicators (KPIs)
- Management of VMP Safety Recalls
- Evaluation of quality defect related safety issues
- Storage of the documentation on the PQE Group or customer server
- Management of Competent Authorities inspections
More generic Quality Assurance SOPs, applicable to PV systems, are available for documentation management, audit execution (internal and external) and planning, non-conformity management, CAPA management, change control, job descriptions and curriculum management, supplier qualification and PQE Group personnel training management.
Finally, there is also a SOP developed as a regulatory service for PV intelligence, useful to PQE Group and customer staff to be updated on the most current regulatory news and changes.
Conclusions
QV Hub is a new digital and sustainable PV system that can be requested by MAHs, exploiting its flexibility and modularity to fulfil their specific PV needs for short or long periods. QV Hub is suitable for small and larger MAHs, as the operational details will be agreed upon in specific PVA-customizations based on a realistic company situation, on the risk level of the company’s products, and because specific risk assessments are performed to customize QV Hub on the MAH’s specific needs.
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