Quality Management in the medicines industry: philosophy


Quality Management in the medicines industry: philosophy and essential elements:

In the medicines industry at large, quality management is usually defined as the aspect of the management function that determines and implements the “quality policy”, i.e. the overall intention and direction of an organization regarding quality, as formally expressed and authorized by top management. The basic elements of quality management are:

– An appropriate infrastructure or “quality system”, encompassing the

organizational structure, procedures, processes and resources;

– Systematic actions necessary to ensure adequate confidence that a

product (or service) will satisfy given requirements for quality.

The totality of these actions is termed “QA”. Within an organization, QA serves as a management tool. In contractual situations, QA also serves to generate confidence in the supplier. The concepts of QA, GMP, QC and Quality Risk Management (QRM) are interrelated aspects of quality management and should be the responsibility of all personnel. They are described here in order to emphasize their relationship and their fundamental importance to the production and control of pharmaceutical products.

WHO Good Manufacturing Practices For Pharmaceutical Products: Main Principles

(Annex 2, WHO Technical Report Series 986, 2014)

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