Some issues for implementing the requirements for good practices (GxP). Good distribution practice (GDP) (Part 2)
Keywords:good distribution practices, medicines, pharmaceutical market, pharmaceutical quality system
Aim. To conduct a detailed study of the requirements of good distribution practice.
Materials and methods. The analysis of the current Guidelines on good practices (GxP), in particular the Guideline ST-N 42-5.0:2014 of the Ministry of Health of Ukraine “Medicines. Good Distribution Practice” was performed. Interpretations for the implementation of the requirements of good distribution practice based on the experience of audits of distribution companies for GDP compliance with the requirements were proposed.
Results and discussion. The dependence of the correct distribution of medicines on the personnel involved in this process has been studied, and the negative impact on the activity of a wholesale pharmaceutical company in case of non-compliance by the personnel with the relevant requirements has been determined. The benefits and risks that may arise during the distribution of medicines related to the staff have been identified. The requirements for the Authorized (Responsible) Person, the knowledge and experience that he must possess have been determined. The job description of the Authorized (Responsible) Person has been considered in detail. The responsibilities of the Authorized Person of a distribution company are listed.
Conclusions. The detailed analysis proposed will minimize the risks and errors that can lead to a negative impact on the quality of medicines. The appointment of the Authorized Person of a distribution company, the requirements imposed on him, the knowledge and experience that the Authorized Person must possess have been studied in detail. The advantages and risks of the personnel management of a distribution company have been identified.
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