PHARMACEUTICAL AUDIT PROCESS, OUTCOMES, AND IMPLICATIONS–OVERVIEW

The audit process is a crucial component of regulatory compliance and quality assurance in both the United States of America (USA) and the European Union (EU). This review paper compares and analyses the audit processes, results, and ramifications in these two important markets.The study investigates how pharmaceutical audits affect patients’ trust, market stability, and profitability of a company while highlighting the need for adherence to quality standards. Data integrity, supply chain complexity, and adherence to exacting quality standards are just a few of the notable difficulties faced by auditors in the USA and EU. There is a need to have a strong pharmacovigilance system as well to guarantee the security and effectiveness of pharmaceutical products for patients.This study can be useful reference material for stakeholders, decision-makers, and companies looking to increase accountability, reduce risks, and uphold the integrity of a firm’s operations in the global market. A thorough analysis of audit procedures in the USA and EU will facilitate in promotion of effective and efficient manufacturing, control, and distribution of pharmaceutical products while boosting confidence among patients and in the healthcare system as a whole.

ENHANCING OTC MONOGRAPH DRUG REGULATION THROUGH USER FEE PROGRAM

Food and Drug Administration (FDA) has introduced a distinctive regulatory program known as Over-the-Counter Monograph Drug User Fee Program (OMUFA) to improve the efficacy and security of over-the-counter (OTC) medications made available to consumers. The program, which represents a pivotal shift in the regulatory landscape, aims to address the challenges associated with the oversight of OTC monograph drugs. The OMUFA's primary objective is to expedite the review and approval process of OTC monograph drugs while maintaining stringent safety standards. By imposing user fees on manufacturers and sponsors seeking to bring new OTC products to market or seeking updates for existing ones, the program is designed to support the FDA's ability to allocate additional resources for timely reviews and assessments. This work delves into the key components and mechanics of the OMUFA, such as the user fee structure, types of submissions covered, and the corresponding performance goals established for the FDA. While acknowledging the benefits of the OMUFA, this work also discusses potential challenges and concerns raised by industry stakeholders and consumer advocacy groups. This critical regulatory initiative has the potential to facilitate further research and discussions on optimizing drug safety and access within the OTC market through required modifications and initiatives.