مقاله انگلیسی رایگان در مورد مدیریت ریسک کیفیت در طول توزیع خوب دارویی – الزویر ۲۰۱۸

The distribution operation of pharmaceutical products has a fundamental obligation to maintain quality till shelf life and deliver a safe product to patients. An understanding of quality risk associated with the product shall enable supply chain managers to handle the pharmaceutical distribution more effectively. Pharmaceutical companies, during supply chain, face much quality risk. The risk disrupts the distribution of medicine in many ways such as their quantity and quality product delivery at the right time. Therefore, quality risk management during the distribution process of pharmaceutical products is highly recommended. Risk management principles are utilized in many areas of business including finance, manufacturing, insurance, occupational safety, public health, pharmacovigilance, and by agencies regulating these industries. Although there are some examples of the use of quality risk management in the pharmaceutical industry today, they do not represent the holistic approach that risk management has to offer across the supply chain network. It has been observed that the majority of risks during operations of the pharmaceutical supply chain are internal risks due to processes, people, and functions mismanagement which could be managed by suitable mitigation strategies [1]. The Quality risk management (QRM) is a systematic process for the assessment, control, communication and review of risks to the quality of the drug (medicinal) product. Further, QRM concept depends upon the understanding of terms ‘Quality’ and ‘Risk’. The term Quality means “The degree to which a set of inherent properties of a product, system or process fulfills requirements” (ICHQ9) and as per ISO/IEC Guide 51, the term Risk means “The combination of the probability of occurrence of harm and the severity of that harm” [۲]. The quality risk management process involves: a. Hazards (sources of harm) that can adversely influence drug quality characteristics b. Extent of harm c. Sub processes critical for quality ‘International Conference on Harmonization of Technical Requirement for Registration of Pharmaceutical Products for Human Use’, also known as ICH is an international agency which has issued guidance for the healthcare industry. ICH has described ‘Quality Risk Management’ in section Q9. The guidance ICH Q9 explains a process and methodology for QRM to add value. US Food & Drug Administration (FDA) has issued an identical guidance paper that serves as a foundation or resource document that supports other ICH Quality documents and complements existing quality guidelines within the pharmaceutical industry and regulatory environment [3,14]. According to corollary drawn from quality management principle there are two primary principles of quality risk management: (i) The evaluation of the risk to quality should be based on scientific knowledge and ultimately link to the protection of the patient; and (ii) The action and documentation of the quality risk management process should commensurate with the level of risk. A scheme for quality risk management is outlined in the diagram (Fig. 1). The emphasis on each component of the QRM framework might differ from case to case but a robust process will incorporate consideration of all the elements of quality risk.