Risk Assessment of Technology of Preparation Based on Recombinant Human Interleukin-7 and Its Perspective Validation

Tetiana Lutsenko, Valentina Motronenko, Yuriy Gorshunov, Alexander Galkin

Abstract


Background. Quality management is a very important activity of any industrial enterprise, especially when it comes to manufacturing products in health care (drugs, including medical immunobiological preparations, medical devices, cosmetics, dietary supplements, etc.). Risk-oriented thinking enables an organization to identify factors that may cause rejection of its processes and its quality management system for planned results to establish preventive controls to minimize negative impacts and the greatest possible shaft advantage of the opportunities as they arise. The logical continuation of the risk assessment is validation processes. This article is a fragment of the complex scientific and technical work on the development and standardization of biotechnology products based on recombinant human interleukin-7 (rhIL-7).

Objective. Justification for approaches to risk assessment in the technology for getting preparation based on rhIL-7 in the form of nasal spray and particularly risk assessment of the production process, and perspective validation of developed technologies.

Methods. The methodology of risk assessment according to ISO 14971:2009 “Medical devices. Guidelines for risk management” was used. Pharmacopoeial methods were used to control the process and product quality (potentiometric determination of pH, osmolality, sterility). The integrity of the filters was determined by the method according to the manometer producer.

Results. The work consistently study approaches to risk assessment in the technology for getting preparation based on rhIL-7 in the form of nasal spray and particularly risk assessment of the production process, and the validation of promising technologies developed. Selection of guidelines on risk assessment was conducted for Guidelines for Good Manufacturing Practices, ISO 9001:2015, ISO 13485:2005, and ISO 14971:2009. The greater acceptability of the use of the past two standards was showed. Technological production scheme is presented and qualitative approach to analyze the identified risks is applied. For the most critical stage of production (preparation of sterile solution) the validation process is conducted.

Conclusions. The feasibility of risk assessment in the technology for getting preparation based on rhIL-7 in the form of nasal spray according to ISO 14971:2009 together with the system using risk analysis and critical control points is theoretically justified. It was found that the most critical step in the production is part of the preparation of a sterile solution, which includes the preparation of intermediate filtering and sterilizing drug. The conducted prospective validation of the most critical stages of the technology demonstrated its stability and compliance with established eligibility criteria.

Keywords


Recombinant human interleukin-7; Quality management; Risk analysis; Critical control points; Validation

References


Quality Management Systems. Requirements, DSTU ISO 9001:2015 (ISO 9001:2015, IDT), 2016 (in Ukrainian).

N.O. Vetyutneva et al., “Current status and trends of legal regulation in the field of drug quality”, Farmacevtychnyj Zhurnal, vol. 3, pp. 66–74, 2014 (in Ukrainian).

Ya.M. Derenska, “Quality management project in a pharmaceutical company”, Upravlinnya, Ekonomika ta Zabezpechennya Yakosti v Farmaciyi, vol. 3, pp. 10–16, 2011 (in Ukrainian).

Medicines. Good Manufacturing Practice, Guidance ST-N MOZU 42-4.0:2016 (approved by the Ministry of Health of Ukraine of 29.07.2016 no. 798), 2016 (in Ukrainian).

T.M. Lutsenko et al., “Justification of composition and technology of preparation based on recombinant human interleukin-7”, Academic Journal of Lviv Polytechnic National University, Ser. Chemistry, Materials Technology and their Application, vol. 841, pp. 174–180, 2016 (in Ukrainian).

T.M. Lutsenko et al., “Substantiation of parameters for standardization of drugs based on recombinant human interleukin-7”, Academic Journal of Lviv Polytechnic National University, Ser. Chemistry, Materials Technology and their Application, vol. 812, pp. 175–183, 2015 (in Ukrainian).

T.M. Lutsenko et al., “Methods of assessing biological activity of recombinant human interleukin-7 and stability study of the preparation on its basis”, Naukovi Visti NTUU KPI, no. 3, pp. 48–54, 2016 (in Ukrainian). doi: 10.20535/1810-0546.2016.3.65102

T.M. Lutsenko et al., “Validation of biological activity testing procedure of recombinant human interleukin-7”, Ukr. Biochem. J., vol. 89, no. 1, pp. 82–89, 2017. doi: 10.15407/ubj89.01.082

Medical Devices. Guidelines for Risk Management, DSTU ISO 14971:2009, 2012 (in Ukrainian).

State Pharmacopoeia of Ukraine, vol. 1, 2nd ed. Kharkiv, Ukraine: Ukrainian Scientific Pharmacopoeial Center for Quality of Medicines, 2015 (in Ukrainian).

Medical Devices. Quality Management Systems. Regulatory Requirements, DSTU ISO 13485:2005, 2007 (in Ukrainian).


GOST Style Citations


 

 





DOI: https://doi.org/10.20535/1810-0546.2017.3.101132

Refbacks

  • There are currently no refbacks.


Copyright (c) 2017 NTUU KPI