Some issues for implementing the requirements for good practices (GxP). Good distribution practice (GDP)

Authors

  • R. O. Gurzhii UKRMEDCERT LLC
  • N. V. Lytvynenko UKRMEDCERT LLC

DOI:

https://doi.org/10.24959/nphj.20.21

Keywords:

good distribution practices, medicines, pharmaceutical market, pharmaceutical quality system

Abstract

Aim. To conduct a detailed study of the materials of good distribution practice.
Materials and methods. The analysis of current guidance documents of good practices (GxP), namely Guideline 42-5.0:2014 “Medicines. Good Distribution Practice” has been performed. Interpretations for the implementation of good distribution practice requirements based on the experience of conducting audits of distribution companies for GDP compliance have been proposed.
Results and discussion. It has been determined that Good Distribution Practice is a good practice that regulates the requirements for the subjects of the pharmaceutical market of Ukraine, who are engaged in the storage and distribution of medicinal products – wholesale distributors (in some cases, importers). Historical aspects of implementation of proper distribution practice have been studied. The problems of interpretation of the requirements of the guiding documents of Ukraine on good practices and time periods of improvement of its versions in the EU and Ukraine are presented. The principles and requirements of Guideline 42-5.0:2014 “Medicines. Good Distribution Practices” have been analyzed in detail, and directions for their implementation, benefits and risks associated with each item under research in the Guide are presented.
Conclusions.The detailed analysis proposed allow minimizing the risks and errors that may have a negative impact on the quality of drugs.  Introduction of a pharmaceutical quality system in the company in accordance with a requirements of good distribution practice will also prevent from entering of counterfeit medicines into the legal supply chain.

Author Biographies

R. O. Gurzhii, UKRMEDCERT LLC

deputy director, WHO consultant, EU GDP Association member

N. V. Lytvynenko, UKRMEDCERT LLC

Head of the Expert Department 

References

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Guidelines of 7 March 2013 on Good Distribution Practice of Medicinal Products for Human Use. (2013). Official Journal of the European Union, C 68, 81.

Directive 2011/62/EC of the European Parliament and of the Council amending Directive 2001/83/EC as regards the prevention of the entry into the legal supply chain of falsified medicinal products. (2011). Official Journal of the European Union, L 174, 74.

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Ministerstvo okhorony zdorov’ia Ukrainy. (2016). Likars’ki zasoby. Nalezhna vyrobnycha praktyka : Nastanova ST-N MOZU 42-4.0:2016. Kyiv, 357.

PI 006-3/ PIC/S Recommendations on validation master plan installation and operational qualification non-sterile process validation cleaning validation. (2007). Pharmaceutical inspection convention pharmaceutical inspection cooperation scheme.

Published

2020-09-24

Issue

Section

Organization and Economy of Pharmacy