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A paradigm shift to achieve quality initiatives throughout the manufacturing process

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Amit Chopra, Managing Director, India and Middle East, Thermo Fisher Scientific
Amit Chopra

Amit Chopra, Managing Director, India and Middle East, Thermo Fisher Scientific highlights the need to ensure quality of materials throughout the pharma manufacturing process and outlines how solutions from Thermo Fisher can help meet stringent cGMP requirements

The global portable analytical instrument market is expected to grow at a CAGR of almost 6 per cent during the period between 2017-2021. Raw material inspection is a critical step in the quality control process with a tremendous impact on customer safety, speed and the cost of production. Global and Indian pharma manufacturers are seeking technologies that will allow them to approach a 100 per cent raw materials inspection goal, without prohibitive financial or staffing investments. In this ever expanding and competitive market, it is more essential than ever to implement efficient ways to ensure the quality of raw materials at the point of receipt, dispensing booth in a plant where APIs are being manufactured, to the addition of excipients during secondary manufacturing, all the way through the finished product inspection. Material identification is critical to sustaining product quality, while positively affecting throughput and production costs, and ultimately, helping to ensure consumer wellbeing.

With increased regulatory scrutiny and the rise of global supply chains, pharma and biotechnology manufacturers need to ensure the quality of materials throughout the process—from incoming raw material through the finished product.

The specificity of Raman offers the ability to distinguish between small molecule compounds – which are typically strong Raman scatters and NIR reflectance measurements well suited for larger molecules – making the microPHAZIR RX the ideal analyser for large molecule compounds such as celluloses and other excipients used for secondary manufacturing. These rugged analysers are engineered with attention to meet requirements and perform non-destructive analysis directly through sealed packaging, eliminating the time and material waste associated with more traditional methods.

The Thermo Scientific TruScan RM, based on Raman spectroscopy, and the Thermo Scientific microPHAZIR RX, based on Near-Infrared (NIR) spectroscopy are developed with in-depth pharma industry experience enabling pharma manufacturers to obtain fast, accurate material identity verification with ease and convenience. Additionally, both analysers are designed with revolutionary algorithms that allow users to quickly develop methods, enabling immediate release of raw materials into production. With more than 600 GMP installations worldwide, the Thermo Scientific handheld Raman and the NIR analysers help identify 90 per cent of pharma compounds in seconds. These analysers provide tools to customers that enable customers to meet the stringent requirements of current good manufacturing practices (cGMP) to ensure enhanced product quality and a secure supply chain.

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