FORMATION OF THE QUALITY MANAGEMENT SYSTEMS AT STATE LABORATORIES FOR A MEDICINES CONTROL
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.
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.
Copyright (c) 2017 Viacheslav Lebedynets, Olena Tkachenko
This work is licensed under a Creative Commons Attribution 4.0 International License.
Our journal abides by the Creative Commons CC BY copyright rights and permissions for open access journals.
Authors, who are published in this journal, agree to the following conditions:
1. The authors reserve the right to authorship of the work and pass the first publication right of this work to the journal under the terms of a Creative Commons CC BY, which allows others to freely distribute the published research with the obligatory reference to the authors of the original work and the first publication of the work in this journal.
2. The authors have the right to conclude separate supplement agreements that relate to non-exclusive work distribution in the form in which it has been published by the journal (for example, to upload the work to the online storage of the journal or publish it as part of a monograph), provided that the reference to the first publication of the work in this journal is included.