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Due to Brexit (the UK chose to exit the European Union (EU) by vote) when the UK became a third country, the need for the RPi arose in the UK and this was defined by the MHRA via guidelines including The Human Medicines Act 2012.

The process of evaluating the quality and compliance of your company as a supplier or subcontractor that provides products or services to the new pharmaceutical customer is a pharmaceutical customer audit. Typically, the quality assurance unit of the new pharmaceutical customer or an external auditor hired by them conducts these audits.

A Quality Management System (QMS) comprises all of the policies, processes, and procedures (SOPs) to guarantee consistent and high-quality production of pharmaceuticals. A Quality Management System (QMS) should be tailored to the unique requirements of the pharmaceutical company and regulatory standards. It must encompass all product lifecycle stages, including research, development, manufacturing, distribution, and post-marketing surveillance.