Measuring the performance of quality assurance processes: pharmaceutical industry deviation management case study |
| |
Authors: | Zorana Boltic Nenad Ruzic Mica Jovanovic Slobodan Petrovic |
| |
Institution: | (1) Hemofarm A.D. Beogradski put bb, 26300 Vrsac, Serbia;(2) Faculty of Technology and Metallurgy, University of Belgrade, Karnegijeva 4, 11000 Belgrade, Serbia |
| |
Abstract: | This article presents experience from the practice of a successful pharmaceutical company related to design and implementation
of performance measures (PMs) for deviation management linked to the analysis of impact on the production cost for the selected product. Case study focuses
on PMs within good manufacturing practice (GMP) processes related to quality assurance (QA) and quality management, with the aim
of complying with its future requirements proposed by the European Commission. Critical areas were identified based on data
gathered from the industrial deviation database. Implementation of the suggested corrective actions showed significant improvement
in terms of reducing their number for more than 50% per selected deviation category. The results obtained in the course of
this practice-oriented study contribute to further improvement of deviation management in the pharmaceutical industry and
performance measurement of other GMP processes. The suggested performance measurement concept and problem-solving techniques
may serve both practitioners and the decision-makers within QA and quality control (QC) in order to improve their processes
by implementing relevant regulatory requirements for quality management and maintain compliance. |
| |
Keywords: | |
本文献已被 SpringerLink 等数据库收录! |
|