Abstract
Auditing is a vital function within a pharmaceutical company nowadays. Quality audit is a review and evaluation of all or part of a quality system with the specific purpose of improving it. It is one of the means to examine pharmacy programs and ensures that the procedures and reimbursement mechanisms comply with the contractual and regulatory requirements. A quality audit is usually conducted by external or independent experts or by a team designated by management for this purpose. These audits can be extended to suppliers and contractors as well. An audit will assess the strengths and weaknesses of quality assurance and quality assurance processes, the results of which assists in improving processes and building a better system for company benefits. This article focuses on various aspects of quality auditing in the pharmaceutical industry including its principles, objectives, importance and benefits and planning along with the deficiencies that are likely to occur during the process. This review comprises a well-organized summary of various guidelines available till date using the Google Scholar search engine and the keywords listed below.
Highlights
Audits are conducted to ascertain the validity and reliability of the information; to provide an assessment of the internal control of a system
Questions may be asked several times in different ways or to different people depending on their level of responsibility (Operator, Supervisor, etc.) in order to get a complete answer
A quality systems approach calls for audits to be conducted at planned intervals to evaluate effective implementation and maintenance of the quality system and to determine if processes and products meet established parameters and specifications
Summary
Audits are conducted to ascertain the validity and reliability of the information; to provide an assessment of the internal control of a system. It provides management with information on the efficiency with which the company controls the quality of its processes and products [1]. The audit in simple terms could be defined as the inspection of a process or a system to ensure that it meets the requirements of its intended use [2]. Instead of considering the audit as an intrusive and potentially threatening review, pharmacies should consider the audit as a quality control mechanism. The results of the audit and the resulting corrective actions ensure all the involved parties that a program works in accordance with established rules of practice [4]
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