Dermatological Disorder Discovery: Unveiling Skin Conditions Through Survey on Herbal Marketed Formulation

Abstract

This study examines trends in inspectional observations documented on FDA Form 483 over the past five years (2019-2023) with a focus on human drugs, medical devices, and biologics. This research aims to identify overarching patterns in 483 observations across different product categories (drugs, medical devices, biologics, delve deeper into specific regulations by analyzing the most frequent CFR code violations within designated focus areas and intends to assess the effectiveness of current quality system practices in the pharmaceutical industry based on identified trends. This study analyzes publicly available data on USFDA website related to 483 notifications for five-year period. All observations were categorized in eight subgroups namely documentation practices, GMP/GLP compliance, contamination control, quality control/Quality assurance, personnel qualifications, labelling regulations, clinical trial conduct and management oversight. One additional subgroup was created for biologics namely donor factors. Data analysis will be conducted using Microsoft Excel with the aid of charts and graphs. An analysis of the data revealed a general decrease in observations across medical devices, drugs, and biologics. However, for medical devices, documentation and Good Manufacturing Practices require the most attention. Documentation, Contamination, and Quality Assurance/Quality Control (QA/QC) were the most frequent observations for drugs, with QA/QC violations showing a positive downward trend. For Biologics, issue related to donors, indicates a need for a comprehensive review and potential tightening of procedures related to blood or tissue donation. The most frequent citations in 21 CFR in medical devices to Quality System Regulation and investigational devices, while biologics citations focused on stringent quality control for blood products. For drugs, the emphasis remains on enforcing good manufacturing practices throughout production, with a high number of citations for adulterated medications. In conclusion, to ensure a sustained decrease in 483 notifications, a culture of continuous improvement is vital. Manufacturers must delve deeper by conducting rootcause analyses to pinpoint and rectify underlying problems. Implementing strictercontamination control protocols alongside robust documentation procedures andelectronic data capture systems are crucial steps. F ostering a quality-centricenvironment requires regular review of inspection findings, implementing correctiveactions, and establishing a systematic quality improvement program encompassing allfacets of manufacturing. This comprehensive approach will solidify a focus on qualityand minimize the likelihood of future notifications.