The method of process quality management system performance evaluation at industrial pharmaceutical companies

V. O. Lebedynets

Abstract


The importance of complete information about the quality management system (QMS) status doesn’t require additional study because of its basing on these management solutions in organization of business in companies and enterprises in general.

Aim. To develop a method of evaluating the effectiveness of the quality management system (QMS) of manufacturing pharmaceutical company (MPC).

Materials and methods. Objects of a research were the materials of internal audits of the QMS. The technique is to test of QMS process for determining the degree to which audit criteria detailed by 10-point scale.

Results. Actuality of the problem of QMS evaluating is proved. This problem solution is proposed by the method of “scoring”.

Conclusions. This technique characterizes the ability of QMS meet its purpose to ensure stable performance of all the requirements for activities affecting product quality or performance of obligations to the customers. It also provides an opportunity to assess the ability of the QMS to ensure the achievement of quality objectives. This can be considered a major and comprehensive performance characteristic of the QMS of MPC. Measurable QMS conformity assessment make it possible to track changes, analyze trends of QMS and take timely corrective and preventive actions, reducing risks and improving constantly.


Keywords


quality management system; pharmaceutical quality system; effectiveness; efficiency; method of “numerical scoring”; ICH Q10 guidance; GMP guidance; ISO 9001, ISO 9000

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DOI: https://doi.org/10.24959/uekj.17.15

Abbreviated key title: Upr. ekon. zabezp. âkostì farm.

ISSN 2519-8807 (Online), ISSN 2311-1127 (Print)