Understand Raw Material Quality

First Things First: Understand Raw Material Quality
By Paul Entrop, Product Team Director, Analyzers, Thermo Electron Corp.
PharmaManufacturing.com
Understanding the impact of raw material variability is critical to ensuring final product quality and to successfully initiating a PAT program.The last few years, and the knowledge that the industry spends over $90 billion each year on manufacturing alone, have brought increased regulatory attention to the importance of controlling the pharmaceutical manufacturing process. FDA's PAT Initiative and the resulting “Guidance to Industry” promises to play a key role in pushing pharmaceutical manufacturing into the 21st century.To start off any PAT program on the right track, and to gain the process understanding required, pharmaceutical manufacturers must start at the very beginning. They must understand the impact that varying raw material quality has on the final product.Existing techniques only address part of the raw material quality picture. Traditional approaches to determining raw material quality are based on identity, chemical purity and pharmacopeial methodologies. These methods are all useful and important, but in most pharmaceutical processes, they are not enough because they can’t address physical changes in the product. Such changes are extremely important in an operation such as tablet manufacturing, in which powdered materials are handled, mixed, modified and compressed, changing their physical attributes.It’s not unusual for OOS tablet batch failures to be traced back to a problem with a raw material ingredient’s physical property. This occurs, even when that raw material passed all the traditional inspection processes in place for incoming materials.NIR’s Role in Quality AssuranceAlready well established as an analytical tool for pharmaceutical testing, FT-NIR can provide information on both chemical quality attributes and physical properties quickly, easily and without destroying the sample.The technique can be used to create a raw material information database containing information on both chemical and physical properties, and batch-to-batch variance. Use of the technique can also speed up quality testing, eliminating the time spent waiting for results, and reducing inventory and the need for raw material quarantine.When part of a properly designed PAT effort, the analytical method offers fast, repeatable and reliable results. Once an NIR raw material database has been set up, links between quality performance later in the process, and FT-NIR spectra can often be established.From these links, causal relationships can be explored and investigated, or the system can be deployed to screen incoming raw materials to determine how suitable they are for the given process. Thus, raw material qualification via FT-NIR can become the first critical control point in the process, enabling the use of more advanced process control techniques.Important points to consider are first and foremost, whether the material is the correct one. Does it meet specifications for purity or water content? Is it useable in the process, given its chemical and physical properties? Often, the same API in a form with a different shape or particle size, can lead to surprising product failures.FT-NIR can help manufacturers address all these issues, allowing users to predict physical characteristics by analyzing spectra and the reference method for the trait. It also allows manufacturability to be predicted based on trait and output data.

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