Quality Audits - Viewpoints of Auditing in the Pharmaceutical Industry

Alili Idrizi, Edita and Ahmeti Lika, Sihana and Bexheti, Dore and Dauti, Merita and Janevik-Ivanovska, Emilija (2022) Quality Audits - Viewpoints of Auditing in the Pharmaceutical Industry. The Albanian Journal of Medical and Health Sciences, 60. pp. 1-12. ISSN 2413-3892

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Abstract

In the pharmaceutical industry, audits are an essential part of the institutions’ quality management system ensuring compliance with regulatory expectations, supporting products quality assurance and customer satisfaction. Depending on the category of the audit, it is usually performed by the qualified group of professionals assigned by management for this intention, external or regulatory agency. This review covers the main viewpoints of auditing in the pharmaceutical industry including its goals, objectives and benefits, mandatory regulatory standards and principles of auditing along with the role and responsibilities of the auditor and their code of conduct during an audit. It outlines the management of an audit program with the main methods of gathering audit information and
the key stakeholders of the quality audit. It also emphasises a five-phase process which includes audit planning and preparation, conducting fieldwork, audit reporting, and following up on corrective action plans. In brief, this is a structured summary on the entire process of an audit and the importance of creating an environment of good relationship between stakeholders, employees and auditors in delivering values to audit activities of any size.

Item Type:	Article
Subjects:	Medical and Health Sciences > Health sciences Medical and Health Sciences > Other medical sciences
Divisions:	Faculty of Medical Science
Depositing User:	Emilija Janevik
Date Deposited:	04 Feb 2023 21:40
Last Modified:	04 Feb 2023 21:40
URI:	https://eprints.ugd.edu.mk/id/eprint/31314

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