Focused on process analytical technologies and real-time analytics, IFPAC is the leading process analytical chemistry (PAC) conference and exhibition – especially as PAC relates to the pharmaceutical industry. At IFPAC 2017 in Maryland, USA, Quality by Design (QbD) and Process Analytical Technology were the main topics of discussions that was held at Maryland, USA.
This year I was delighted to deliver two presentations in the technical sessions:
I also enjoyed discussions with leading delegates from industry and academia on how Selected Ion Flow Tube Mass Spectrometry (SIFT-MS) could be accommodated within upcoming QbD and PAT regulations.
For many years, IFPAC has been focused towards getting together practitioners from industry, academia and government to discuss new trends in technology, standards, and controls. QbD principles have been used to advance the product and process quality in different industries. The concept of QbD requires a thorough understanding of a product and its process of manufacture, necessitating an investment in time and resources upfront in the discovery and development of a product. Successful implementation of QbD concepts requires cooperation across a multitude of company teams, from R&D to manufacturing to quality control and regulatory affairs.
With the FDA anticipating so many changes in the pharmaceutical and food industries, many are now looking at technologies that can help them improve the quality of their products and manufacturing processes. This is where SIFT-MS can add value to their existing processes and provide them upper hand on monitoring their manufacturing processes and also check the quality of the final products. Some of the key areas where SIFT-MS provides an ideal solution are discussed below.
- In the pharma industry, the current techniques to test the raw materials and excipients involves techniques such as GC-MS, NIR, etc. Although these techniques are widely used and accepted, they do have limitations such as speed, sensitivity and, selectivity. SIFT-MS can cover all these gaps by providing benefits such as real-time analysis of raw materials and excipients that can assist in the quality checks of these products.
- In recent times, there has been increased concern about the levels of volatile compounds in packaging materials used in the pharma industry. There have been reports that these compounds can leaching and react with the drug, potentially affecting its potency. SIFT-MS is ideally suited to high-throughput analysis of volatile compounds at trace levels and hence can be used to enhance packaging screening.
- Measuring the purity of drugs forms an important part of the quality checks in the pharma industry. Currently HPLC is used to monitor reactions for impurities during API development. SIFT-MS is an ideal solution for this application because it can analyze for impurity compounds continuously and selectively.
Overall, the current QbD and PAT approaches that were discussed at IFPAC are a very good fit for SIFT-MS. There are number of key applications where SIFT-MS can be the right solution – especially in the quality control and continuous manufacturing areas – thus helping these industries to save time and improve product quality, which in turn will save money.