PHARMACEUTICAL AUDIT PROCESS, OUTCOMES, AND IMPLICATIONS–OVERVIEW

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dc.contributor.authorK., KRUTHIKA R.en_US
dc.contributor.authorMISHRA, SANGITHAen_US
dc.contributor.authorM., ARJUNen_US
dc.contributor.authorVENKATESH, M. P.en_US
dc.date.accessioned2024-09-24T08:25:03Z
dc.date.available2024-09-24T08:25:03Z
dc.date.issued2024-05
dc.description.abstractThe 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.en_US
dc.identifier.affiliationsDepartment of Pharmaceutics, JSS College of Pharmacy, JSS Academy of Higher Education and Research, Sri Shivarathreeshwara Nagar, Mysuru-570015, Karnataka, Indiaen_US
dc.identifier.affiliationsDepartment of Pharmaceutics, JSS College of Pharmacy, JSS Academy of Higher Education and Research, Sri Shivarathreeshwara Nagar, Mysuru-570015, Karnataka, Indiaen_US
dc.identifier.affiliationsDepartment of Pharmaceutics, JSS College of Pharmacy, JSS Academy of Higher Education and Research, Sri Shivarathreeshwara Nagar, Mysuru-570015, Karnataka, Indiaen_US
dc.identifier.affiliationsDepartment of Pharmaceutics, JSS College of Pharmacy, JSS Academy of Higher Education and Research, Sri Shivarathreeshwara Nagar, Mysuru-570015, Karnataka, India, and Guest Assistant Professor, Faculty of Pharmaceutical Sciences, UCSI University, Malaysiaen_US
dc.identifier.citationK. KRUTHIKA R., MISHRA SANGITHA, M. ARJUN, VENKATESH M. P. . PHARMACEUTICAL AUDIT PROCESS, OUTCOMES, AND IMPLICATIONS–OVERVIEW . International Journal of Pharmacy and Pharmaceutical Sciences . 2024 May; 16(5): 7-15en_US
dc.identifier.issn0975-1491
dc.identifier.issn2656-0097
dc.identifier.placeIndiaen_US
dc.identifier.urihttps://imsear.searo.who.int/handle/123456789/231174
dc.languageenen_US
dc.publisherInnovare Academic Sciences Pvt. Ltd.en_US
dc.relation.issuenumber5en_US
dc.relation.volume16en_US
dc.source.urihttps://doi.org/10.22159/ijpps.2024v16i5.49277en_US
dc.subjectPharmaceutical auditen_US
dc.subjectProcessen_US
dc.subjectOutcomesen_US
dc.subjectImplicationsen_US
dc.subjectAudit regulationsen_US
dc.titlePHARMACEUTICAL AUDIT PROCESS, OUTCOMES, AND IMPLICATIONS–OVERVIEWen_US
dc.typeJournal Articleen_US
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