The purpose of a quality audit is to assess or examine a product, the process used to produce a particular product or line of products or the system supporting the product to be produced. A quality audit is also used to determine whether or not the subject of the audit is operating in compliance with governing source documentation such as company directives and applicable standards and regulations. In contrast to this there are inspections, which are conducted by accrediting organizations and inspectorate (regulatory) bodies.
Audits are systematic and independent examinations of manufacturing related activities and documents to determine whether the process is being conducted and records made according to protocols and SOPs. Audits are part of the quality system and are designed to be part of continuous improvement. They are undertaken in a way which is generally co-operative. In contrast, an inspection is the act by a regulatory authority of conducting an official review of documents, facilities, records, and any other resources that are deemed by the authority to be related to the manufacture of the product.
There are different ways for conducting audits and inspections, and indeed there is a difference between and audit and inspection. This article surveys the more common approaches and how they differ and provides summaries of different styles of audits.
The reference is:
Sandle, T. (2021) Techniques for conducting quality audits, GMP Review,19 (4): 4-8
Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)
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