Risk-based approach for validation of technological process

Authors

  • V. G. Nikityuk SCC “VADEMECUM” Ltd
  • T. M. Shakina SCC “VADEMECUM” Ltd

DOI:

https://doi.org/10.24959/nphj.20.22

Keywords:

medicinal product, Pharmaceutical Quality System (PQS), Quality Risk Management (QRM), process validation (PV), strategy for process control

Abstract

Good manufacturing process is one of the most significant risk exclusion factors for patients due to lack of safety, efficacy or quality. Therefore, it is critical that the ability to continuously medicinal products of the required quality in accordance with the specifications and quality attributes has been demonstrated.
The aim of our research and this publication is to formulate a practical risk-oriented approach to process validation of the pharmaceutical production, taking into account modern requirements for both the process validation itself and the quality risk management system, in terms of defining and justifying the process control strategy for the subsequent routine manufacturing commercial batches of medicinal products, that would eliminate the risk for patients associated with lack of safety, efficacy or quality of medicinal products.
Materials and methods. The subject of the work is the analysis of modern requirements for validation of pharmaceutical production process and quality risk management system as processes of pharmaceutical quality system, and determination on this basis of practical model of implementation of risk-based approach to process validation (PV) – definition, justification and confirmation of effectiveness (efficiency) of control strategy of technological process of medicines production.
Results and discussion. According to the requirements of current guidelines, process validation should include the collection and evaluation of data that scientifically substantiate that the process can consistently ensure proper quality product throughout the product lifecycle, starting with its development, and validation activities should be based on quality risk management principles. The model of risk-oriented definition of process control strategy is considered, which is able to provide the possibility of practical application to any groups of pharmaceutical products and processes. It can be perceived as basic and, taking into account the specifics of each company, can be modified or detailed.
Conclusions. Based on the analysis of the place and role of process validation, we have proposed a comprehensive unified model for the implementation of a risk-based approach to process validation in terms of defining a process control strategy based on the principles of quality risk management recommended for the pharmaceutical industry.

Author Biographies

V. G. Nikityuk, SCC “VADEMECUM” Ltd

Candidate of Pharmaceutical Sciences

T. M. Shakina, SCC “VADEMECUM” Ltd

Candidate of Pharmaceutical Sciences

References

ICH Q10. Pharmaceutical Quality System. Available at: https://www.ema.europa.eu/en/ich-q10-pharmaceutical-quality-system.

Liapunov, M., Bezuhla, O., Soloviov, O. et al. (2011). Nastanova ST-N MOZU 42-4.3:2011 «Likars’ki zasoby. Farmatsevtychna Systema Yakosti». Kyiv: Ministerstvo okhorony zdorov’ia Ukrainy.

EudraLex. The Rules Governing Medicinal Products in the European Union. Vol. 4. EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use. Available at: https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/pdfsen/

2018_annex2_en.pdf.

EudraLex. The Rules Governing Medicinal Products in the European Union. Vol. 4. EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use. Annex 15. Qualification and Validation. Available at: https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/2015-10_annex15.pdf.

Guide to Good Manufacturing Practice Medicinal Products for Medicinal Product. Annexes. PI 009-14. Geneva, 2018. Available at:

https://picscheme.org/docview/1946.

Liapunov, M., Bezuhla, O., Soloviov, O. et al. (2016). Nastanova ST-N MOZU 42-4.0:2016 «Likars’ki zasoby. Nalezhna vyrobnycha praktyka». Kyiv: Ministerstvo okhorony zdorov’ia Ukrainy, 357.

Guideline for Industry. Process Validation: General Principles and Practice (January 2011). Available at: https://www.fda.gov/files/

drugs/published/Process-Validation--General-Principles-and-Practices.pdf.

Guideline on Good Manufacturing Practice: Non-sterile product validation. TRS N 992 / WHO. Geneva, 2015.

ICH Q9. Quality Risk Management. Available at: https://www.ema.europa.eu/en/ich-q9-quality-risk-management.

Liapunov, M., Bezuhla, O., Soloviov, O. et al. (2011). Nastanova ST-N MOZU 42-4.2:2011 «Likars’ki zasoby. Upravlinnia Ryzykamy Dlia Yakosti». Kyiv: Ministerstvo okhorony zdorov’ia Ukrainy.

ICH Q8. Pharmaceutical Development. Available at: https://www.ema.europa.eu/en/documents/scientific-guideline/international-conference-harmonisation-technical-requirements-registration-pharmaceuticals-human-use_en-11.pdf.

Guideline on process validation for finished products – information and data to be provided in regulatory submissions (November 2016). EMA/CHMP/CVMP/QWP/749073/2012. Available at: https://www.ema.europa.eu/en/documents/scientific-guideline/guidelineprocess-

validation-finished-products-information-data-be-provided-regulatory-submissions_en.pdf.

Published

2020-09-24

Issue

Section

Organization and Economy of Pharmacy