臨床薬理学および生物薬剤学

抽象的な

Pharmacuetical Quality Audits

Mukta Suresh Sangale

Auditing is a vital function within a pharmaceutical company nowaday.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.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.Quality audit is the process of systematic examination of a quality system carried out by an internal or external quality auditor or an audit team. It is an important part of organization’s quality management system and is a key element in the ISO quality system standard. This Project  is to provide brief information regarding quality audit and it’s importance in continuous improvement of any quality System.