TY  - JOUR
AU  - Boltić, Zorana
AU  - Ružić, Nenad Lj.
AU  - Jovanović, Mica
AU  - Petrović, Slobodan
PY  - 2010
UR  - http://TechnoRep.tmf.bg.ac.rs/handle/123456789/1721
AB  - 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.
PB  - Springer, New York
T2  - Accreditation and Quality Assurance
T1  - Measuring the performance of quality assurance processes: pharmaceutical industry deviation management case study
EP  - 636
IS  - 11
SP  - 629
VL  - 15
DO  - 10.1007/s00769-010-0709-2
ER  - 

@article{
author = "Boltić, Zorana and Ružić, Nenad Lj. and Jovanović, Mica and Petrović, Slobodan",
year = "2010",
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.",
publisher = "Springer, New York",
journal = "Accreditation and Quality Assurance",
title = "Measuring the performance of quality assurance processes: pharmaceutical industry deviation management case study",
pages = "636-629",
number = "11",
volume = "15",
doi = "10.1007/s00769-010-0709-2"
}

Boltić, Z., Ružić, N. Lj., Jovanović, M.,& Petrović, S.. (2010). Measuring the performance of quality assurance processes: pharmaceutical industry deviation management case study. in Accreditation and Quality Assurance
Springer, New York., 15(11), 629-636.
https://doi.org/10.1007/s00769-010-0709-2

Boltić Z, Ružić NL, Jovanović M, Petrović S. Measuring the performance of quality assurance processes: pharmaceutical industry deviation management case study. in Accreditation and Quality Assurance. 2010;15(11):629-636.
doi:10.1007/s00769-010-0709-2 .

Boltić, Zorana, Ružić, Nenad Lj., Jovanović, Mica, Petrović, Slobodan, "Measuring the performance of quality assurance processes: pharmaceutical industry deviation management case study" in Accreditation and Quality Assurance, 15, no. 11 (2010):629-636,
https://doi.org/10.1007/s00769-010-0709-2 . .