Disparities versus Similarities: WHO GPPQCL and ISO/IEC 17025:2017 International Standards for Quality Management Systems in Pharmaceutical Laboratories

Authors: M. A. Okezue, K. L. Clase, S. R. Byrn, P. Shivanand

Abstract:

Medicines regulatory authorities expect pharmaceutical companies and contract research organizations to seek ways to certify that their laboratory control measurements are reliable. Establishing and maintaining laboratory quality standards are essential in ensuring the accuracy of test results. ‘ISO/IEC 17025:2017’ and ‘WHO Good Practices for Pharmaceutical Quality Control Laboratories (GPPQCL)’ are two quality standards commonly employed in developing laboratory quality systems. A review was conducted on the two standards to elaborate on areas on convergence and divergence. The goal was to understand how differences in each standard's requirements may influence laboratories' choices as to which document is easier to adopt for quality systems. A qualitative review method compared similar items in the two standards while mapping out areas where there were specific differences in the requirements of the two documents. The review also provided a detailed description of the clauses and parts covering management and technical requirements in these laboratory standards. The review showed that both documents share requirements for over ten critical areas covering objectives, infrastructure, management systems, and laboratory processes. There were, however, differences in standard expectations where GPPQCL emphasizes system procedures for planning and future budgets that will ensure continuity. Conversely, ISO 17025 was more focused on the risk management approach to establish laboratory quality systems. Elements in the two documents form common standard requirements to assure the validity of laboratory test results that promote mutual recognition. The ISO standard currently has more global patronage than GPPQCL.

Keywords: ISO/IEC 17025:2017, laboratory standards, quality control, WHO GPPQCL

References:

[1] World Health Organization. Annex 1 WHO good practices for pharmaceutical quality control laboratories 2010.
[2] Mitra A. Fundamentals of quality control and improvement: John Wiley & Sons; 2016.
[3] Valdivieso-Gómez V., Aguilar-Quesada R. Quality Management Systems for Laboratories and External Quality Assurance Programs. InTech; 2018.
[4] International Standard Organisation. ISO/IEC 17025:2017 General Requirements for the Competence of Testing and Calibration Laboratories. ISO/IEC 17025:2017(E) ed: International Standards Organization; 2017.
[5] WHO. Laboratory Quality Standards and their Implementation. New-Delhi, India: World Health Organization, Regional Office for South-East Asia; 2011 (cited 2020 15 June). Available from: https://apps.who.int/iris/bitstream/handle/10665/205405/B4741.pdf?sequence=1.
[6] Fm‘t Hoen E, Hogerzeil HV, Quick JD, Sillo HB. A quiet revolution in global public health: The World Health Organization’s Prequalification of Medicines Programme. Journal of public health policy. 2014;35(2):137-61.
[7] WHO PQP. Prequalification of medicines by WHO. World Health Organization; 2013.
[8] ISO Central Secretariat. Friendship Among Equals: Recollections from ISO's first fifty years. Geneva. Switzerland: ISO Central Secretariat; 1996 (cited 2020 June 9). Available from: https://www.iso.org/files/live/sites/isoorg/files/about%20ISO/docs/en/Friendship_among_equals.pdf.
[9] ISO. ISO About us: Structure and Governance 2020 (Available from: https://www.iso.org/structure.html.
[10] ISO Standard Catalogue: ICS: ISO; 2020 (cited 2020 June 9). Available from: https://www.iso.org/standards-catalogue/browse-by-ics.html.
[11] McInturff T., editor Changes to ISO/IEC 17025: 2017 A High-Level Overview. 2018 IEEE Symposium on Electromagnetic Compatibility, Signal Integrity and Power Integrity (EMC, SI & PI); 2018; Long Beach, CA, USA: IEEE.
[12] Anastasopoulos G. The new ISO/IEC 17025:2017. CAL LAB the International Journal of Metrology. 2017:pp. 30–5.
[13] Ghernaout D., Aichouni M., Alghamdi A. Overlapping ISO/IEC 17025: 2017 into Big Data: A Review and Perspectives. International Journal of Science and Qualitative Analysis. 2018;4(3):83.
[14] ILAC. International Laboratory Accreditation Cooperation: Facts and figures 2020 (Available from: https://ilac.org/about-ilac/facts-and-figures/.
[15] Grochau I. H., Caten C. S. T., De Camargo Forte M. M. Current American landscape in laboratory accreditation according to ISO/IEC 17025. Accreditation and Quality Assurance. 2017;22(2):57-62.
[16] WHO PQ Team. WHO List of Prequalified Quality Control Laboratories March 2020 (31). Available from: https://extranet.who.int/prequal/sites/default/files/documents/PQ_QCLabsList_29.pdf.
[17] Abrahamsen R. K. Experience of accreditation of an analytical laboratory and certification of the quality system in dairies. Meieriposten. 1998;87(9):274-80.
[18] Anastasopoulos G. I., Ramakrishnan P. S., Anastasopoulos I. G., editors. Improving Performance of Testing Laboratories – A Statistical Review and Evaluation. Sustainable Issues in Transportation Engineering GeoMEast 2019 Sustainable Civil Infrastructures; 2019: Springer.
[19] Oliver E. L. Implementation of ISO/IEC 17025 Practices in Small and Academic Laboratories. Ann Arbor, MI: The University of Nebraska-Lincoln; 2018.
[20] Tene C. V. T., Yuriev A., Boiral O. Adopting ISO management standards in Africa: barriers and cultural challenges. ISO 9001, ISO 14001, and New Management Standards: Springer, Cham; 2018. p. 59-82.
[21] Tsimillis K. C. Data integrity: requirements set in the accreditation standards. Accreditation and Quality Assurance. 2019;24(3):165-71.
[22] Masanza M. M., Nqobile N., Mukanga D., Gitta S. N. Laboratory capacity building for the International Health Regulations (IHR 2005 ) in resource-poor countries: the experience of the African Field Epidemiology Network (AFENET). BMC Public Health. 2010;10(Suppl. 1): S8.
[23] Zima T. Accreditation of Medical Laboratories–System, Process, Benefits for Labs. Journal of medical biochemistry. 2017;36(3):231-7.
[24] Nicklin W., Fortune T., van Ostenberg P., O'Connor E, McCauley N. Leveraging the full value and impact of accreditation. International Journal for Quality in Health Care. 2017;29(2):310-2.
[25] Lebedynets V., Tkachenko O. Formation of the Quality Management Systems at state laboratories for a medicines control. Technology transfer: innovative solutions in medicine. 2017:64-6.
[26] Putri Z. T., Fahma F., Sutopo W., Zakaria R. A. Framework to Measure Readiness Level of Laboratory for Implementing ISO/IEC 17025: A Case Study. IOP Conference Series: Materials Science and Engineering. 2019; 495:012011.
[27] Cebekhulu B. M. B., Mugova C., editors. Quality Control in a University Laboratory: Evaluating the Gap between ISO/IEC-17025 Requirements and the Thin Section Laboratory’s Processes. 7 International Conference on Industrial Engineering and Operations Management (IEOM); 2017; Bristol, UK.
[28] Wilson I. G., Smye M., Wallace I. J. C. Meta-audit of laboratory ISO accreditation inspections: measuring the old emperor's clothes. MicrobiologyOpen. 2016;5(1):95-105.
[29] Wilson I. G. Accreditation—a verification ritual lacking verification. BMJ: British Medical Journal (Online). 2018;363.
[30] WHO PQ Team. WHO List of Prequalified Quality Control Laboratories. July 2019. p. 31.
[31] Habibie M. H., Basuki B., editors. Risk-based thinking on calibration and testing laboratory: Current challenge in transition period. IOP Conf Series: Materials Science and Engineering; 2019: IOP Publishing.
[32] The quality calibration handbook; developing and managing a calibration program Portland: Ringgold Inc; 2007 (Scitech Book News, 31:(n/a). Available from: Retrieved from https://search-proquest-com.ezproxy.lib.purdue.edu/docview/200132833?accountid=13360.
[33] Sevgi L. Accreditation: Crucial in World Trade, Public Safety, and Human Rights. IEEE Antennas and Propagation Magazine. 2014;56(4):265-75.
[34] World Health Organisation. WHO good practices for pharmaceutical microbiology laboratories. In: WHO Technical Report Series. No.961, editor. 2011. p. 25.
[35] Association of Public Health Laboratories. Laboratory Costs of ISO/IEC 17025 Accreditation: A 2017 Survey Report. Silver Spring, MD: Association of Public Health Laboratories; 2018.
[36] WHO. Essential medicines and health products 2020 (Available from: https://www.who.int/medicines/areas/quality_safety/quality_assurance/guidelines/en/.
[37] WHO. Essential medicines and health products: GMP questions and answers 2020 (Available from: https://www.who.int/medicines/areas/quality_safety/quality_assurance/gmp/en/.
[38] Elapanda S., Rao U. V. A., Choudary K. S. A. Integration of lean six sigma framework in testing laboratories Quality Management System with specific reference to ISO 17025. Journal of Management (JOM). 2019;6(3):pp. 1-13,.
[39] Tricker R. ISO 9001: 2015 for small businesses. London and New York: Routledge; 2016.
[40] Valdivieso-Gómez, V., & Aguilar-Quesada, R. (2018). Quality management systems for laboratories and external quality assurance programs: InTech.