Work optimization of the manufacturing process validation in production of sterile medicinal products

  • O.A. Shestopal -
  • YU.V. Pidpruzhnikov -
Keywords: validation, risk analysis, manufacturing process, test statistic

Abstract

It is demonstrated that the risk fnalysis is an important element in preparation for the validation. The methodological approach to the assessment of risk typical for sterile pharmaceutical products, in accordance with the established categories is developed. The decision-making behaviour to carry out the validation is provided, which enables to justify the optimization of validation work, to aim efforts of validation groups at the areas of concern, save resources and accelerate the validation process.

References

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2. Instruction 42-3.5-2004. Process validation. Good manufacturing practice. - K .: Ministry of Health of Ukraine, 2004. - 12 p.
3. Final Concept Paper. Q 10: Pharmaceutical Quality Systems dated September 9, 2005 - ICH SC, November 10, 2005 - http://www.ich.org
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5. Good manufacturing practice for sterile pharmaceutical products. In: WHO Expert Committee on Specification for Pharmaceutical Preparations. Thirty-sixth report. WHO Technical Report Series, # 902. Annex 6 - World Health Organization. - 2002. - 220 p.
6. ICH Harmonized Tripartite Guideline. Q9: Quality Risk Management. Current Step 4 version dated 9 November 2005 - ICH SC, 9 November 2005 - http://www.ich.org
7. PIC / S Recommendations PI 007-3 "On the validation of aseptic processes". - 2007. - 17 p. http: // www.picscheme.org/index.php
Published
2020-03-11
How to Cite
Shestopal, O., & Pidpruzhnikov, Y. (2020). Work optimization of the manufacturing process validation in production of sterile medicinal products. Farmatsevtychnyi Zhurnal, (2), 10-15. Retrieved from https://pharmj.org.ua/index.php/journal/article/view/838
Section
Management, marketing and logistics