By SV Rajan, Vertical Head for Manufacturing and Finance – Product Development, Orion™ ERP
Pharmaceutical manufacturing is a capital-intensive industry that discovers, develops, produces, and markets life-saving pharmaceutical drugs. This vertical is highly regulated and has emerged as one of the largest, in terms of volume (goods produced) and value, showing rapid growth across the globe.
Contemporary and comprehensive technologies such as ERP (Enterprise Resource Planning) software systems are expected to change the landscape of the pharmaceutical industry with smart solutions as well as in-demand industry features developed especially for the pharmaceutical manufacturing vertical.
Addressing industry challenges through ERP
- Recipe and formula management
Recipe and formula management is critical and there is always an urgent need of formulation of new drugs. Without a reliable technology managing this imperative step in the manufacturing process is a significant challenge.
- Critical ingredients formula/drug recipes can be effectively handled by a manufacturing ERP tailored for the pharma industry. It should include the following functionalities – New Formula Development, Formula Management, Sample Management, and Formula Costing to prove beneficial.
- Stringent compliance requirements
Pharmaceutical manufacturing is a highly regulated industry. With people’s wellness and well-being at stake, drugs must be declared effective and safe before they could go to the global pharmaceutical market. Therefore, enhanced drug regulations as well as approval processes by government institutions are put in place.
- ERP for the pharma industry is designed to monitor and manage the numerous strict regulatory compliances that are mandatory like FDA 21 CFR Part 11 (Title 21 of the Code of Federal Regulations) compliance, MSDS (Material Safety Data Sheet), cGMP (Current Good Manufacturing Practice), etc. Pharmaceutical ERP systems provide industry features that encompass the entire spectrum of quality management, formula management and traceability. Moreover, regional taxation compliance is also supported by a pharmaceutical ERP system.
- Drug product costing
Numerous factors contribute to assigning the final cost to a drug. Among many other considerations, pharma manufacturing enterprises must calculate the expenses associated with procuring materials, managing raw materials, implementing data-driven manufacturing, and the like.
In the absence of a unified centralized platform, the associated cost of activities are individually recorded in separate departments. When any change is made in this data, it takes time for the stakeholders and employees to be in-sync with the update. This aspect makes it difficult to nail down the final product cost.
- A centralized data hub established by a pharmaceutical ERP system provides real-time actionable organizational data that aids the firm to make data-driven decisions as well as devise smart business strategies. When any change is made in the data, everyone can see the update and understand it’s effect in real-time. Therefore, stakeholders and employees have 360-degree visibility into expenses associated with multiple variables across departments and can control costs accordingly.
- Perfunctorily managed inventory
It’s imperative for pharmaceutical businesses to keep track of their inventories, balance risks associated with inventory shortages, and so on. Manual inventory management is counterproductive, and in the pharmaceuticals industry, inventory is key.
- Pharmaceutical ERP system enables implementation of smart inventory management to help streamline the complete asset lifecycle and fully automate inventory tracking. Advance inventory management helps pull down costs, improve inventory tracking accuracy, enjoy greater control and tighter compliance.
- Numerous quality processes
Robust quality compliance and management are the need of the hour. Quality products are to be consistently produced with no scope for error throughout the integrated processes from inception to fruition.
- Quality Analysis and Control on each batch of production (drugs) can be effectively achieved with a well-equipped pharmaceutical ERP system. An ERP enables quality processes like in-progress quality check (IPQC), version controls, sampling, stability testing, process inspection and Certificate of Analysis (COA), and validates the quality of produced drugs. Furthermore, quality checks are implemented at inbound, in-process and outbound of material movements to ensure superior quality of manufactured drugs.
- Demand forecasting
Devising reliable market forecasts and enhancing customer service levels are critical challenges due to inefficient demand forecasting. Demand forecasting is an essential component to stay ahead in the competition and match the supply to demand aspect. Additionally, ensuring that all the goods are produced at the desired time and delivered seamlessly is yet another challenge.
- Pharmaceutical ERP systems provide real-time organizational data to stakeholders and employees. This data can be meticulously analyzed to forecast the demand for a product or service even before it is produced and delivered. Moreover, accurate demand forecasting helps to meet customer demands, manage inventory intelligently, prevent supply chain disruptions, aid an enterprise in forecasting and managing the expected sales, etc.
Benefits of ERP in Pharma industry:
- Integrate, optimize, streamline operations, processes, and practices across multiple sites
- Centralized data hub for quick and easy access to data for decision making
- Gain a complete overview of organizational processes
- Batch traceability of raw materials and finished goods
- Increase flexibility in the production process
- Compliance with stringent regulations
- Quality and formula management
- Inventory management and optimum material utilization
- Eliminate wastage with expiry alerts and first-expired, first-out (FEFO) based material consumption
- Maintain secrecy of formulas
Orion™ from Azentio Software is a customizable ERP solution, that has a proven track record to be a one-stop technical solution for the pharmaceutical industry. With its smart key solutions and cutting-edge industry features, it has scripted success stories worldwide and across businesses of all sizes. Explore the possibilities to grow your pharma business. Visit