Quality Management Systems for Excipients

A Quality Management System is the means whereby Quality is managed within a company. It comprises policies and procedures above and beyond those required for the manufacture of a particular lot or batch of an excipient. The Quality Management System sets out how Quality is to be implemented, and Senior Management within the Company must be involved in the management of Quality. Quality Management should be a both a 'top-down' and 'bottom-up' activity. There are several different approaches to the implementation of Quality Management Systems; e.g. ISO 9000, HACCP, etc.

FinnBrit Consulting can advise companies on the suitability of their approach to Quality Management Systems.

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