Online testing and monitoring of quality of medicines and consumables
ABSTARCT :
Suitable technological module for testing and monitoring of quality of medicines and consumables being received in hospitals would be required so that the system ensures necessary compilance and rejection of low quality supplies without manual intervention
EXISTING SYSTEM :
Despite this far-reaching definition, it is common practice for pharmaceutical companies to allocate most of their resources for pharmacovigilance departments mainly to the collection and assessment of individual case safety reports (ICSRs), for example, scientific literature, websites, EudraVigilance, FDA adverse event reporting system (FAERS) and so on, with the primary aim of identifying and reporting undesirable side effects in compliance with the applicable regulatory requirements and timelines.
A large proportion of these ICSRs represent well-known side effects of medicines. While this is important to detect unknown adverse drug reactions (ADRs) for several years after first approval of new chemical entities, regulations require that these activities are routinely undertaken for all products including older medicines such as generic medicinal products with well-established safety profiles.
For the latter, in many instances, the risk management plans (RMPs) have removed risks that were considered important safety concerns based on the reasonable expectation that by that time the risks are already well characterised and managed by standard clinical practice.
DISADVANTAGE :
Data Privacy and Security Risks: Storing sensitive information online can expose data to breaches and unauthorized access, potentially compromising patient confidentiality.
Reliability of Internet Access: Dependence on stable internet connections can lead to disruptions in monitoring, especially in remote areas with limited connectivity.
Technical Challenges: Issues such as software bugs, hardware malfunctions, and compatibility problems can hinder effective monitoring.
Standardization Issues: Different regions may have varying regulations and standards, making it difficult to ensure uniform quality across borders.
PROPOSED SYSTEM :
This system will feature real-time data acquisition from advanced sensors and laboratory instruments, enabling continuous quality assessment throughout the production and supply chain. Key modules will include automated quality control testing, regulatory compliance tracking, and detailed analytics, which will facilitate immediate identification of quality deviations and streamline corrective actions.
A robust document management system will ensure easy access to standard operating procedures and compliance documentation, while an incident management module will systematically log and address quality-related incidents. User-friendly interfaces and training resources will support staff in effectively utilizing the system.
By incorporating predictive analytics, the platform will not only monitor current quality parameters but also forecast potential issues, promoting proactive management.
Overall, this innovative system will foster transparency, improve operational efficiency, and ensure that medicines and consumables meet the highest quality standards, ultimately safeguarding patient health and enhancing public trust in pharmaceutical products.
ADVANTAGE :
Real-Time Monitoring: Continuous, real-time data collection allows for immediate identification of quality issues, enabling swift corrective actions.
Increased Efficiency: Automation of testing processes reduces the time and labor involved in traditional quality control methods.
Cost-Effectiveness: Over time, online monitoring can reduce operational costs by minimizing waste and improving resource allocation.
Enhanced Transparency: Online systems can provide accessible data for stakeholders, fostering transparency and trust in the quality assurance process.
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