Some issues for implementing the requirements for good practices (GxP). Good distribution practice (GDP)
DOI:
https://doi.org/10.24959/nphj.20.21Keywords:
good distribution practices, medicines, pharmaceutical market, pharmaceutical quality systemAbstract
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.
References
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