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SIGMA TECH

SigmaTech is software for achieving the objectives of QbD. It is useful for designing and building quality into the process using the DOE technique.

The quality of pharmaceuticals has been under debate for decades. In the current scenario of strict rules, the pharmaceutical industry is facing challenges to achieve the desired quality of medicines. The products need to be free from contamination and deliver the therapeutic benefits as promised on the label. Quality by Design (QbD) is an approach for achieving the economic development of drugs with superior quality and resources. According to QbD the Quality of pharmaceutical products should be designed and built during the Research & Development stage and in the manufacturing process. A poorly designed pharma product will show poor safety and efficacy, no matter how many tests or analyses are done to verify the quality. Thus, QbD begins with the recognition that quality can’t be improved by increasing testing of the products, but quality must be built into the product.

QbD is one of the most vital initiatives by the US Food and Drug Administration for the discovery, development, and manufacturing of drugs/medicines. The concept was mentioned in the ICH Q8 guidelines. It focuses on building quality into the product by understating the product and process by which it is developed and manufactured. It also involves understanding the risks involved in manufacturing and how best to mitigate those risks. By understanding the design of products and processes, QbD enhances the product’s efficacy, quality, and safety in the best interest of patients.

Quality by Design (QbD) has become a new concept for the development of quality pharmaceutical products and is an essential part of the modern approach to pharma quality. QbD is the best solution to build quality and efficacy in all pharma products but it is also a major challenge to the pharma industry as the processes in the industry are fixed in time, despite inherent process and material variability. Throughout the designing and development of the pharma product, it is important to define desire product performance profiles like Quality Target Product Profile (QTPP) and identify Critical Quality Attributes (CQAs). It also includes the identification of Critical Material Attributes (CMAs) and Critical Process Parameters (CPPs) as well as a thorough understanding of scale-up principles that link CMAs and CPPs to CQAs.

 

However, if pharma companies fail to obtain quality, it can lead to expensive consequences such as rework, warranty claims, non-compliance, recalls, and lost customer loyalty. Achieving the objectives of QbD is not simple, there are digital maturity lags and the burden of validation challenging product development cycles.

 

SigmaTech addresses these challenges. It is a software developed by Swaroop Tech Services Pvt. Ltd for achieving objectives of QbD and useful for designing and building quality into the process using the Design of Experiments (DOE) technique, risk assessment, and process analytical technology (PAT).

 

This software is a  stand-alone basis that enables the pharma companies to effectively manage everything from quality, process, and product manufacturing, always and according to relevant compliance regulations. The software analyses statistically planned experimental data easily and build the statistical/mathematical model thus providing various simulation techniques for the optimal design of the process. SigmaTech software is useful for applications in the Research & Development of API (active pharmaceutical ingredients), Pharmaceutical formulations, Biotechnology Process, Contract Research work, Chemical Process, and Analytical Research work. The software enables you to build exactly what you need in a fast and cost-effective way and with superior quality. Say goodbye to the ineffective circulation of spreadsheets, word docs, and emails and streamline your process while reducing costs drastically with SigmaTech.

 

For more information on SigmaTech and how it can help achieve the objectives of QbD in your process, request a free demo today.

Key features of this software are

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