Active Pharmaceutical Ingredients (API) Industry is growing rapidly owing to the new developments in medical technologies and improved raw ingredient availability from emerging markets. The top contributors to API Manufacturing are growing powerhouses like India and China. These businesses require sound infrastructure which are expensive to procure and maintain.
This post will highlight some of the key challenges or top priorities for API manufacturers in 2016 as well as enterprise solutions that can support the entire API manufacturing lifecycle.
- Top Priorities of API Manufacturers
- Manage unique production processes
- Global Regulatory Compliance
- Product Quality
- Documentation & Reporting
- Improving Commercial Capabilities
In order to achieve excellence in all these listed areas, API manufacturers should be looking for enterprise solutions that will provide support for key processes like –
- Natural Resources: Isolation & Recovery
- Chemical Synthesis
- Recombinant DNA
Companies must adhere to safety and quality standards set by the respective countries. Fighting counterfeiting and contamination is on top priority. Meeting compliance guidelines as per WHO, GMP, cGMP, FDA, etc. have become crucial for API synthesis.
The enterprise solution or process manufacturing ERPs should definitely support & help them achieve standardization for their business processes across multiple manufacturing facilities. Solutions should be provided for the company’s Finance, Distribution, Manufacturing and Quality Management processes. Efficient supply chain and plant management are requisites to remain competitive and thrive. The ERP solution should be built for operational excellence and to facilitate lean manufacturing practices. The solution should help to -
- Improve Production Quality
- Improve Process Efficiency
- Improve Average Cycle Time and Lead Time
- Manage your process workflows better
- Reduce downtimes & under-utilization of facilities
A robust enterprise solution like Oracle JD Edwards and specific solutions for API Manufacturing offered by vendors will enable timely introduction of new products to market. Such solutions will help the industry provide superior quality products, excellent service to their customers, growth in IP assets and help them focus on research and development for the future.
- Seamless Business Level Reporting
- The solution must give complete visibility into all the planning as well as the into the activities across the product life cycle
- Interactive report which have graphs, tables, charts and lists should be available to the decision makers at real-time
- ERP Solution with built-in Business Intelligence will provide actionable business process insights by leveraging the process-level data across the business
A robust ERP Solution like Oracle JD Edwards will allow the leather and footwear business to improve their competitiveness, bring in process efficiencies and will help bind the sales & order distribution cycle tightly together. An ERP solution designed for the footwear & leather product manufacturers and a vendor with specific industry expertise can help business in going global with innovation and quality.