Title : Impact and challenges supply chain realibity in pharmaceutical process development
Abstract:
Drug delivery systems as a technological system formulate and store drug molecules into suitable forms of medications. Effective process development plays a key role in mitigating risk, accelerating time-to-market, and significantly reducing development costs for pharmaceutical companies. Selecting appropriate raw materials, designing efficient production methods, optimizing critical process parameters are very important in risk reduction. Early identification of impact and challenges in supply chain realibity prevents costly late-stage redesigns. Material constraints necessitating cost-effective sourcing strategies and supply chain reliability for specialized ingredients have huge impact when scaling from laboratory to commercial production. Successfully navigating these challenges requires sophisticated development approaches, careful regulatory planning, strategic material sourcing, and creative engineering solutions to ensure commercial viability. By systematically addressing challenges related to scale-up, optimization, quality control, and regulatory compliance, process development creates manufacturing methods that consistently deliver high-quality medications to patients. It is important to unsure that raw materials flow uninterrupted through integrated processing steps to create finished products. Firstly, we have to know what are the realistic demand management production planning and scheduling. Product portfolios becoming more complex while regulations are becoming more stringent which rises the costs of PSC. Identification of product portfolio, long approval times, batch-to-batch variability and shortages, long lead times for scale-up, capacity constraints, adaptability to short-term demand fluctuations, quality assurance tasks lead times and very-specific products and process. Lead times raw materials get exceed. Entry of new rival products and change in the local regulatory policy can result in demand float throughout the year. The raw materials have to be procured months before the production as they are shipped from oversea suppliers. A sudden drop in demand could cause the production plan to be postponed or cancelled. As a result, excessive raw materials pile up in the warehouse. Requirements of regulatory agencies to withdraw API?s from the market due to impurity and stop production. Recent changes in the operating environment mean that companies are revisiting the components of their supply chains and identifying ways of extracting additional benefits from them. In the new decade, supply chain management and analytics will be shaped by new technologies. By analyzing data from IT-enabled devices and sensors, it is possible to identify patterns and trends that can help to optimize supply chain operations. The adoption of technologies such as supply chain network design, forecasting, predictive analytics, artificial intelligence, technology, and digital platform dashboards would help companies improve their processes, reduce efforts and cycle time, and increase profits.
