Since the FDA first introduced Quality by Design (QbD) principles to the pharmaceutical industry a decade ago, laboratories have been hard at work developing process-based methodologies for ensuring product quality. Because these methodologies enable labs to detect problems earlier and limit damage caused by production errors, the industry has embraced them enthusiastically. There’s a downside, however: monitoring entire production processes, from raw materials to finished product, generates data of a far greater magnitude than older systems that analysed only the end product.
Today, a laboratory’s informatics system directly correlates with the overall quality and the safety of the products that a pharmaceutical company manufactures – an inefficient lab system is detrimental to the business. Without a highly integrated and as close to paperless as possible informatics system in place, the lab cannot play a meaningful role in rooting out production inefficiency. With a tightly integrated laboratory, however, management can rely on the lab as a quality assurance hub, capable of identifying substandard products at many points in the process and, ideally, before they even occur.
Not yet a Subscriber?
This is a small extract of the full article which is available ONLY to premium content subscribers. Click below to get premium content on Manufacturing Chemist.
Subscribe now Already a subscriber? Sign in here.