Risk identification for quality on stage of pharmaceutical development of combined eye drops for glaucoma treatment

Authors

  • Олександр Миколайович Якубчук National University of Pharmacy 53 Pushkinska str., Kharkiv, Ukraine, 61002, Ukraine
  • Світлана Володимировна Русанова National University of Pharmacy 53 Pushkinska str., Kharkiv, Ukraine, 61002, Ukraine
  • Олена Геннадіївна Фетісова National University of Pharmacy 53 Pushkinska str., Kharkiv, Ukraine, 61002, Ukraine
  • Лариса Миколаївна Андрюкова National University of Pharmacy 53 Pushkinska str., Kharkiv, Ukraine, 61002, Ukraine
  • Володимир Костянтинович Яковенко National University of Pharmacy 53 Pushkinska str., Kharkiv, Ukraine, 61002, Ukraine

DOI:

https://doi.org/10.15587/2313-8416.2015.56944

Keywords:

drug, pharmaceutical development, QbD, critical quality attribute, risk assessment, CH Q9

Abstract

Aim: To identify the possible risks associated with critical quality attribute of combined eye drops for the treatment of glaucoma using of common risk evaluation methodologies for plannig a drug quality on the stage of pharmaceutical development.

Methods: The paper used method of causal analysis. The maximal number of factors has been define to identify potential factors that provide most significant impact on the drug quality and Ishikawa diagram - graphical representation of causes and effects has been built.

Results: Analysis allowed to organize the possible factors affecting the drug quality in the generalized categories: quality control methods, medicines and excipients, primary packaging, proper manufacturing conditions and the stage of the process. The most important factors that are carriers of the risk factors and may lead to negative effects have been identified for the generalized categories.

Conclusions: Determined at the stage of pharmaceutical development potential critical quality attribute of AFI, excipients and primary packaging, critical parameters of the process, provide a better understanding, reduction and adoption of risk in subsequent stages of the life cycle of the drug

Author Biographies

Олександр Миколайович Якубчук, National University of Pharmacy 53 Pushkinska str., Kharkiv, Ukraine, 61002

Postgraduate student

Department of Industrial Pharmacy and Economy

Світлана Володимировна Русанова, National University of Pharmacy 53 Pushkinska str., Kharkiv, Ukraine, 61002

Candidate of Pharmaceutical Sciences, associate professor

Department of Industrial Pharmacy and Economy

Олена Геннадіївна Фетісова, National University of Pharmacy 53 Pushkinska str., Kharkiv, Ukraine, 61002

Candidate of Pharmaceutical Sciences, senior research scientist, assistant

Department of Industrial Pharmacy and Economy

Лариса Миколаївна Андрюкова, National University of Pharmacy 53 Pushkinska str., Kharkiv, Ukraine, 61002

Doctor of Pharmaceutical Sciences, senior research scientist, associate professor

Department of Industrial Pharmacy and Economy

Володимир Костянтинович Яковенко, National University of Pharmacy 53 Pushkinska str., Kharkiv, Ukraine, 61002

Candidate of Pharmaceutical Sciences, associate professor

Department of Industrial Pharmacy and Economy

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Published

2015-12-29

Issue

Section

Pharmaceutical Sciences