AT A GLANCE
Batch manufacturing or batch processing in manufacturing are conventional methods used by chemical, pharmaceutical and related sectors. These methods pose various challenges when it comes process management, formula simplification, quality checks and more.Formula management is the core of process manufacturing to manage ingredients and related raw material, making it audit prone and a validated process.Manufacturers are looking for solutions and software to allow the R&D and production team to work together on formulations. Manufacturers need to simplify Formula management and track changes to maintain an audit trail.The pharmaceutical industry faces many challenges related to formula management in manufacturing. Maintaining formula, formula lines, cross-checking the data, managing raw material supply etc. can be a daunting task for the people on shop floor. Any change in formula needs to be communicated and cascaded down to production line operators to make necessary changes while running the manufacturing process smoothly.
We currently live in a modernized, connected world and it is thus essential to bring these modern hi-tech solutions to pharmaceutical formula management. After all, advanced technologies will dominate pharmaceutical manufacturing patterns, trends and changes in the coming future.
According to a survey by The Deloitte Center for Health Solutions, 68% of biopharmaceutical companies think that advances in technology will significantly impact their organizations.
Before we understand how manufacturing software can help in formula management, let us first consider the challenges in this area.
Challenges in Batch Manufacturing and the Need to Simplify Formula Management:
1.Formula Consistency:As stated earlier, pharmaceutical manufacturers need the formulations to be maintained. This would affect the quality and result of the drug (or other pharmaceutical product) being manufactured. In batch manufacturing, formula consistency plays an essential role in getting consistent results. The challenge lies in maintaining this consistency across multiple locations for different batches.
2.Communicating and Implementing Formula/Line Changes:A formula or formula line is subject to change based on batch history, planned vs. actuals, potency values or other unpredictable factors. When changes are not communicated and implemented correctly, pharmaceutical production can be challenging, especially while producing multiple lots. The cost and labor lost in such scenarios is tremendous. Communicating formula changes to all the stakeholders in the process is equally crucial to avoid quality discrepancies.
3.Maintaining and Managing Data:A pharmaceutical manufacturing facility deals with numerous formulations. Bill of Materials (BOM), ingredients, coproducts, byproducts, different formula lines, 3rd party manufacturing within a formula line, vendor management list, supply chain tracking etc. are all interrelated to formula management. This indicates extensive data generated daily, which needs to be collated, documented, and even analyzed, making it a daunting task prone to errors...... Read More
About XcelPros
XcelPros is a Chicago-based company and delivers transformation through technology. We offer business and technology solutions with deep industry experience in Chemical, Pharma, Life Sciences (including Medical Devices, Bio-Medical & Biotech), Insurance, Discrete Manufacturing, Process Manufacturing, Distribution and Food & Beverage.
XcelPros is a Microsoft Gold Partner, Direct Cloud Solutions Provider (CSP) and a Systems Integrator (SI) offering software licensing, implementation and consulting services for Microsoft Dynamics 365, CRM, Microsoft Dynamics AX, Business Intelligence & Analytics (Power BI), SharePoint, Office 365 and Azure (Cloud, IOT, Microsoft Flow amongst many others).
Our mission is to provide integrated technology solutions that amplify impact and empower our customer’s businesses. We believe technology is the key enabler of exponential growth for us and our customers.
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