This blog covers:
- The definition of a Quality Management System (QMS)
- Key components of a QMS
- Benefits and achievements of implementing a QMS
Table of Contents
Introduction
QMS formally known as Quality Management System is the integral and important part of health care industry. So here in this article we explore what is it and what are functions of it in concise way.
It is guided material by GVP module offer clear guidance regarding the framework and procedures governing pharmacovigilance systems and their quality.
In summary, this blog offers a streamlined overview of the GVP Quality Management System, making it easier to grasp its fundamental elements.
GVP presents a clear quality framework, yet numerous companies often overlooking it, needlessly adding complexity to their operations.
To attain your objectives, it’s crucial to focus on necessary developments and address areas where improvement is needed.
Quality Management System
- Quality, within the context of a pharmacovigilance system, can be defined as all the attributes and elements contributing, with varying degrees of probability, to outcomes that align with the objectives of pharmacovigilance.
- To simplify, quality represents the measurable space between the initiation of processes and the resulting outcomes. This measurement is best assessed by comparing against the intended objectives.
- ‘Quality management system’ means a formalised system that provides for comprehensive processes, procedures, and responsibilities for achieving quality policies and objectives to coordinate and direct an organisation’s activities and improve its effectiveness and efficiency in this regard on a continuous basis.
- QMS is a crucial factor in ensuring quality within the healthcare sector.
Several factors influence this quality measurement, including the organizational structure, delineation of responsibilities, established procedures, operational processes, and the allocation of resources within the pharmacovigilance system.
Additionally, effective resource management, adherence to compliance standards, and meticulous record-keeping play pivotal roles in shaping this quality spectrum.
“A well-structured Quality Management System is not just a regulatory requirement—it is the foundation of trust, consistency, and excellence in every process.”
QMS in Pharmacovigilance
The following content serves as a summary of the GVP document, highlighting crucial points that should not be overlooked.
Objectives of QMS
The overall quality objectives of a pharmacovigilance system are:
- complying with the legal requirements and responsibilities;
- preventing public from harm due to adverse reactions arising from the use of authorised medicinal products within or outside the terms of marketing authorisation or from occupational exposure;
- promoting the safety of drugs, by providing timely information about the risks and safety of medicinal products to patients, healthcare professionals and the public; and
- contributing to the protection of patients’ and public health.
Quality cycle
Following GVP guidelines, the Quality cycle in pharmacovigilance encompasses four key activities:
- Quality Planning: Setting up consistent structures through meticulous planning.
- Quality Adherence: Executing tasks in accordance with the established plan.
- Quality Control and Assurance: Continuously monitoring, evaluating, and exercising control.
- Quality Improvement: Enhancing processes through corrective actions and prevention measures based on the above steps’ implemented.
Responsibilities to maintain quality in an organisation
- Verify the presence of well-documented quality system documents that comprehensively describe the processes.
- Confirm the availability of sufficient resources for seamless process execution.
- Guarantee the provision of adequate training.
- Secure compliance management.
- Maintain thorough records (documents) management.
- Conduct regular reviews at defined intervals to prompt necessary CAPA. (To learn more…)
- Execute scheduled audits.
- Assign appropriate roles and responsibilities, ensure clear communication, and provide comprehensive training, ensuring all employees are aware of whom to approach for specific task management and reporting.
- Monitor performance indicators
Key Takeaways
QMS is essential for producing and delivering quality in every business.
QMS should be established based on ISO 9001:2015 standards.
QMS encompasses all processes necessary to ensure quality, significantly impacting overall outcomes.
QMS is more than just documentation; it must include workflows that monitor quality at every stage.
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Conclusion
This article has highlighted key aspects of the Quality Management System (QMS) and its importance in various industries, including healthcare. A well-implemented QMS ensures consistent quality and efficiency in business operations.
Did this content provide clarity? Do you think we missed anything? Share your thoughts and comments below!
Acronyms:
QMS – Quality Management System
GVP – Good Pharmacovigilance Pracice
CAPA – Corrective Action and Preventive Action
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