A brief review on: pharmaceutical audit guide

Author: 
Shital V. Sirsat, Tejal S. Ingole, Vaibhav V. Khomane, Suraj B. Pawar and Sanket S. Motlag

Nowadays, auditing is a important part of a pharmaceutical industry. Quality audit is a review and evaluation of all or part of a quality system with the specific purpose of improving it. We can evaluate different programs of pharmacy and can make sure that the process and methods comply with the regulatory authorities. This audit can be performed externally or by professional expert team who solely performs the function of auditing. Audit not only deal with manufacturers but also done with different channels like supplier and contractors. By performing audit evaluation of quality assurance department and its different process is evaluated, and results came up with this used for improvement in methods and can be used to perform best for company benefits. This article focuses on Evaluating conformity of requirements to ISO 9001, Evaluating conformity of documentation to ISO 9001, Judging conformity of implementation to documentation, Determining effectiveness in meeting requirements and objectives, Meeting any contractual or regulatory requirements for auditing, Providing an opportunity to improve the quality management system, Permitting registration and inclusion in a list of registered companies and Qualifying potential suppliers. This review comprises a well-organized summary of various guidelines available till date using the Google Scholar search engine and the keywords listed below.

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DOI: 
http://dx.doi.org/10.24327/ijcar.2022.1254.0278
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Volume11