When you were graduating from college with marketing and business degrees, you likely never imagined that part of your days would be filled with meetings full of discussions about analytical method validation guidelines.
The fact that your marketing career has taken you into the pharmaceutical industry, however, has meant that spend hundreds of hours in meeting listening to lab and test results about nanoparticle measuring services and upgrades and other kinds of analytical testing laboratory tests. This pharmaceutical career, however, means that you have a far greater understanding of how drug companies, and many other industries for that matter, deal with testing for impurities and finding ways to improve and implement very important analytical method validation guidelines.
The validation of any kind of analytical procedures often involves some commonalities. In fact, the four most common types of analytical procedures include:
- Testing for verification.
- Quantitative impurity content tests.
- Impurity control limit tests.
- Quantitative active moiety test samples for drug products and other selected drug product components.
Analytical development scientists are important people in a number of fields. From food testing to pharmaceutical production, consumers have to be confident about the products that they buy. Furthermore, once the scientists have been able to verify their findings and provide analytical development definitions, this information has to be presented in an acceptable industry specific format. In fact, particle size analysis is the process by which one product can make itself standout from the other products of lesser quality.
Sieving is one of the oldest particle sizing methods and is still widely used for some of the more relatively large particles that are greater than 1mm in size. (ie. > 1mm).
Although some industries still rely on sieving methods for analyzing particle size, however, laser diffraction is one of the most common. for the most part, however, and particle analysis, whether by sieving or laser diffraction method, includes the following steps:
- The random sampling of bulk powders.
- The sub-sampling of specimen bulk samples.
- Preparation and dispersion of specimens.
- Set up and verification of instruments.
- The actual size measurement.
- Interpretation and analysis of data.
- Size result reports.
From scientists to marketing experts, many companies in today’s economy have to deal with the verification and presentation of complicated and complex test results.
