Published October 31, 2017 | Version v1
Journal article Open

FORMATION OF THE QUALITY MANAGEMENT SYSTEMS AT STATE LABORATORIES FOR A MEDICINES CONTROL

Creators

  • 1. National University of Pharmacy

Description

The article reviews the regulatory framework in the field of regulating the activities of laboratories for quality control of medicines at the world and national levels. Taking into account the harmonization of the new version of ISO / IEC 17025 "General competence for testing and calibration laboratories" and ISO 9001: 2015 "Quality management systems. Requirements", the necessity of wide implementation of the process approach and implementation of risk-oriented thinking in the activities of laboratories has been substantiated. The general approaches to implementation of quality management systems in the activity of testing pharmaceutical laboratories are offered. In particular, a typical list of processes of the quality management system (QMS) for the laboratory for quality control of medicines has been developed, and the division of such processes into three groups is proposed: management processes, resource management processes, analytical testing processes. It is substantiated that these groups of processes should be described in the Quality Manual with a mandatory graphic representation of the structure of the process model of the QMS and the description of the conditions for the interaction of processes.

The use of the PDCA cycle within each of the processes has been proven to promote systematic measurement, analysis of activities and the development of effective corrective and preventive actions. The formation of effective QMS in state and private laboratories for quality control of medicines will help to reduce the number and significance of inconsistencies and errors in analytical work and processes, to provide proper guarantees for obtaining reliable results, to increase the awareness of staff in quality management methods and continuous improvement of activities.

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FORMATION OF THE QUALITY MANAGEMENT SYSTEMS AT STATE LABORATORIES FOR A MEDICINES CONTROL.pdf

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References

  • WHO Good practices for pharmaceutical quality control laboratories (2010). Technical Report Series, No. 957, Annex 1. Available at: http://academy.gmp-compliance.org/guidemgr/files/WHO_TRS_957_ANNEX1.PDF
  • ISO/IEC 17025:2005 General requirements for the competence of testing and calibration laboratories (2005). Available at: https://www.iso.org/standard/39883.html
  • Information and documents on laboratory accreditation can be found on the ILAC (International Laboratory Accreditation Cooperation). Available at: www.ilac.org
  • ISO 17034:2016 General requirements for the competence of reference material producers (2016). Available at: https://www.iso.org/standard/29357.html
  • Lebedynets, V. O.; Chernyh, V. P., Pertsev, I. M. (Eds.) (2016). Quality management systems. Pharmaceutical Encyclopedia. Kyiv: Morion, 1536–1537.
  • Lebedynets, V. O., Kovalenko, S. M., Bursakov, A. V. (2011). Formation of quality management systems in state laboratories for the control of medicines. Management, economy and quality assurance in pharmacy, 1 (15), 4–11.
  • ISO/IEC DIS 17025:2016 General requirements for the competence of testing and calibration laboratories (2016). Available at: https://www.iso.org/obp/ui/#iso:std:iso-iec:17025:dis:ed-3:v1:en
  • ISO 9001:2015 Quality management systems – Requirements (2015). Available at: https://www.iso.org/obp/ui/#iso:std:iso:9001:ed-5:v1:en
  • ISO 15189:2012 Medical laboratories – Requirements for quality and competence (2012). Available at: https://www.iso.org/standard/56115.html
  • ISO/IEC 17021-1 Conformity assessment – Requirements for bodies providing audit and certification of management systems – Part 1: Requirements. Available at: https://www.iso.org/standard/61651.html
  • Varchenko, V. G., Sur, S. V., Chernih, V. P., Kovalenko, S. M., Gerasimchuk, T. V., Kovalenko, S. M., Lebedinets, V. O. (2002). Modern requirements for the organization of laboratories for the analysis of the quality of medicinal products. Kharkiv: NPAU, 202.
  • ISO 19011:2011 Guidelines for auditing management systems (2011). Available at: https://www.iso.org/standard/50675.html
  • ISO 10012:2003 Measurement management systems – Requirements for measurement processes and measuring equipment (2003). Available at: https://www.iso.org/standard/26033.html
  • ISO/TR 10013:2001 Guidelines for quality management system documentation (2001). Available at: https://www.iso.org/standard/26978.html
  • ISO/AWI 10015 Quality management – Guidelines for competence management and training (2015). Available at: https://www.iso.org/standard/69459.html
  • Jadaun, G. P. S., Saklani, V., Dixit, S., Jain, R., Singh, S. (2016). Implementing Quality Management System in Pharmaceutical Laboratories. Journal of Analytical & Pharmaceutical Research, 2 (1). doi: 10.15406/japlr.2015.02.00010
  • Gaurav, P. S. J., Harit, K., Vandana, S., Renu, J., Surinder, S. (2015). Quality Management System in Testing Laboratories. JPQA, 1 (1), 53–56.