Driving digitalization in Pharma Manufacturing- Revolutionising Supply Chain through eCapsule

From regulatory requirements to quality control, pharmaceutical manufacturers have always faced a plethora of challenges when it comes to the management of supply chains. According to a leading media outlet , the traded value of medical products has increased from $113 billion in 2000 to $629 billion in 2019 due to the globalisation of the pharmaceutical industry.

Centers for Disease Control and Prevention (CDC) reported a 20% loss in COVID-19 vaccines due to cold chain issues amid the global pandemic. Reduced supply chain visibility, lack of innovation, and complexity lead to disruption which in turn affects consumer satisfaction and the company’s reputation.

In such a situation, Enterprise Resource Planning (ERP) solutions become indispensable tools that integrate key functions like production planning, procurement, inventory management, warehouse management, resource scheduling and distribution, which in turn, allow real-time tracking, improved coordination, reduced costs, minimised risks and increased operational agility.

Regulatory Compliance

Pharmaceutical manufacturers have strict regulations from regulatory bodies like the FDA, EMA, and CDSCO for new innovations, as well as for existing products. These regulations work in the interest of patients’ health, and uphold the integrity of pharmaceutical companies by ensuring safe and ethical business practices. Defiance of these regulations often lead to compromise in quality, efficacy and safety of medical drugs.

ERP solutions, such as eCapsule , rigorously comply with these regulations and support pharmaceutical manufacturers in seamlessly integrating them into their operational processes, leading to enhanced efficiency and minimising errors. It also includes features like audit trails and automated workflows which simplify compliance.

Quality Control & Quality Assurance

Quality Control (QC) involves rigorous testing and inspections at various levels of production to identify and prevent defects in the manufacturing process of pharmaceutical products. It confirms that products meet the required quality standards before reaching the market, therefore ensuring patient safety and public health.

Meanwhile, Quality Assurance (QA) maintains a robust system of processes, documentation, and standards to ensure there are no quality issues. This system is not only dedicated to ensuring product quality but also extends its control over the entire manufacturing and distribution processes.

eCapsule enhances quality assurance and control by calibration, raw-material batch sampling, batch requests and reports, reducing inaccuracy and human error, and ensuring there is no compromise in the quality of dispatched products. It also includes GMP controls such as First Expiry, First Out (FEFO), and allows the raising of a purchase order to approved vendors only by QA. It automatically calculates the required quantities to be dispensed based on the Assay Value captured by the QC department.

Cold Chain Management

Vaccines and certain other medications require strict temperature control to maintain efficacy and stability. Meeting these requirements poses challenges such as the need for temperature monitoring, specialised storage facilities, and transportation methods that prevent temperature fluctuations, all of which become crucial factors.

eCapsule, being an open-integration platform, has the capability to connect with IoT devices and data loggers to capture room temperature and provide visibility to the operators.

Financial Management

Tracking and analysing finances are a top priority for pharmaceutical manufacturers as they help make informed decisions on the administration of their processes and products, thereby reducing unwanted costs on raw materials and manufacturing.

Poor finance management practices portray the company as inefficient and unsustainable and prevent business growth. However, eCapsule helps integrate functions such as cost centre management, budgeting, financial statements, accounts receivable & payable management, and streamlines these processes to make them more efficient.

Supply Chain Visibility

One of the main benefits of enhanced supply chain visibility is that it allows companies to monitor and analyse Key Performance Indicators (KPIs), like inventory levels, production planning overviews, process checks in the manufacturing stages, and customer reviews making way for better decision making and timely responses to customer demands.

eCapsule helps supply chain visibility by gathering data from various departments of the company, like, procurement of raw materials, inventory, production, distribution, and sales to provide a holistic view of processes to all stakeholders. This not only increases transparency and accountability but also protects pharmaceutical manufacturing companies from any liabilities. eCapsule can also provide visibility on lead times, taking into account the time taken for the raw materials and packing materials to reach the plant from the time of raising the Purchase Order.

Globalisation

When pharmaceutical companies become global, they face multiple challenges in managing the various processes of the company. Raw material sourcing from various countries, distributing finished products globally and other complexities, such as trade regulations, tariffs, and taxes require a standardised system that ensures the easy flow of processes, right from sourcing and manufacturing, to distribution and sales.

eCapsule automates and streamlines these processes. It also automates the process of calculating and updating tariffs and taxes for different countries and regions, facilitating necessary documentation for regulatory compliance that helps navigate trade regulations, geopolitical risks and cultural differences.

Conclusion

In today’s fast-paced world, ERP solutions like eCapsule are not just a choice, but the only answer to these complex challenges faced by pharmaceutical manufacturers. It streamlines and automates the workflow, ensures ethical business practices, and helps reduce costs and minimise risks, thereby increasing efficiency and upholding integrity.

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