دانلود رایگان مقاله انگلیسی مدیریت ریسک کیفیت در طول توزیع خوب دارویی - راه حل محتمل - الزویر 2018

ABSTRACT

Quality of medicinal product is an important facet throughout lifecycle owing to its importance as acceptance criteria at customer’s end. Drugs regulatory agencies have issued guidelines for quality risk evaluation, mitigation and review management. Quality risk management has become an integral part of quality management system at manufacturing plants. Procedures for deviation control, change control, investigations of market complaints and batch failures are dealt with the principle of quality risk management at the manufacturing facility. The exploratory study shows a dearth of research on quality risk management during supply chain operation, however, a few study has been carried out by keeping financial risk into account. This study addresses the gap in literature on quality risk management during supply chain operations. There are cases of unresolved customer complaints and batch failures originated due to inadequacies during distribution of pharmaceutical products. In absence of established quality risk management system during product shipment, there is no effective preventive plan related to risk factors. A corollary of manufacturing quality risk management has been drawn to the distribution of pharmaceutical products through this study. The quality risk management during pharmaceutical distribution may be useful to avoid market complaints, drug recalls, and regulatory actions. This study produces one unique model solution for industry professionals and policymakers opening a scope to reduce the product rejection thereby paving the way for substantial business growth.

7. Conclusion and recommendations

The quality risk management (QRM) is an activity that integrates identification of quality risk, risk analysis, risk assessment, developing strategies to manage them. Some traditional QRM exercises are focused on pharmaceutical manufacturing only, however, the ignorance of quality risk during distribution poses business challenges finally leading to market complaints, recall, rejections, and regulatory actions. A model way to deal quality risk during distribution operation provides more insight to supply chain strategy. This also helps to develop the understanding of the quality risk of supply chain management that facilitates logic-based risk control decisions for overall business growth through entrusted quality brand creation. The quality risk management during pharmaceutical good distribution practices helps effective management of quality risks to ensure supply continuity is a significant challenge has following key steps:

i. Make quality and risk management as key elements during supply chain

ii. Identify the supply chain quality risk through holistic approach

iii. Establish risk mitigation tools during supply network

iv. Ensure that supplier risk management is an on-going activity, not one-time action

v. Enhance communication about risk elements and controls exercised across the supply chain

vi. Maintain comprehensive procedure, task and responsibility metrics