Author: Nigel J Smart PhD

In a world of rapidly changing dynamics, any mechanism that can integrate QC laboratory operations with the manufacturing suite to increase efficiency will prove popular with site management. Why is this, what are some of the drivers which might influence decision-makers? Four prime drivers include; the potential for higher throughput, a reduction in cycle time, the opportunity to reduce waste in all its many forms and for the potential to streamline the overall process if it’s properly integrated with production, quality assurance and supply chain. Adding together the impact of these individual reasons produces a very significant benefit which...

Einstein said it best, science for science sake without good measurement would not lead to progress. With this in mind then, it is vital that we measure our performance whether it be in the laboratory, the manufacturing suite or some other department such as quality assurance. In fact, today, to attain the desired state of what we are calling the “Brilliant Factory State”, it is important to measure the whole enterprise so that we take advantage of and capitalize on the performance of the entire organization. Today in the new global economy this is vital to maintain competitiveness. Processing...

Much is often spoken about culture and the need to change culture in a constantly evolving environment, but it’s a subject that is very complex and variable and success often depends on how well you understand the local situations and how they’re playing into the site operation as much as more macro organizational changes may be. Today we all too often hear that we need to change the culture of the a group or site, but less often do we see situations where time has been taken to understand what’s not working and whether there are nuances that will...

Since the final rule was issued in June 2008 by the FDA (21 CFR 111),for the manufacturing and packaging cGMP’s, the industry has had plenty of time to address the many issues that were responsible for plaguing the public with substandard and frequently dangerous products, that in some cases were contaminated with pesticide residues. As with other life science processes & products regulated by the FDA, the basic premise has been to assure that proper controls are in place so that they can be processed in a consistent manner to meet agreed-upon quality standards and specifications. These rules and...

With the ever-increasing competitive landscape for Life Sciences Products, be they pharmaceuticals, diagnostics or medical devices, having an efficient, compliant business process for the development and manufacture becomes an imperative and not a “nice to have.” As globalization gathers pace and emerging markets in Asia and South America become serious challengers to the traditional dominance by North American and European players, having a streamlined operation with the inclusion of all the previous “bit part” technologies become a necessary and central feature to the business. Organizational architecture with the complementary techniques and systems that provide for end to end oversight...