Author: Nigel J Smart PhD

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...

Commercialization of products that are destined for US market distribution, whether manufactured domestically or by a third party will require inspection by the US Food and Drug Administration – FDA. Products will be licensed either as branded molecules through the New Drug Approval process (NDA), and generic’s follow the Abbreviated New Drug Approval process (ANDA). Biological products also follow a variance of the NDA process through a BLA, biological license application process. Both processes (NDA & ANDA), are rigorous and will require inspection of the material manufacturing site, including supporting sites, testing facilities and any third-party facility that provides...

Today Pharma 4.0 is all the rage. Like other fads and buzzwords, it is being banded around like the new panacea for all ills etc. in our industry, but that is perhaps a gross misrepresentation. What it is is a recognition of a mechanism to develop the science and understanding of what effects, controls and enables quality, safety and effectiveness in the development and production of medical products. Over the last 10 to 15 years industry and the regulatory agencies have together progressed mechanisms and standards to redefine measurement, standards and key performance indicators in an integrated approach to...

The documentation process is an extremely important feature in cGMP compliance. That said, there is still a lot of confusion in the industry, particularly in areas of the life sciences business where regulations are changing, such as in the tissue/regenerative medicine space and combination products. Understanding what is core data and therefore what constitutes primary documentation is very important if one is not going to fall into the trap of data/application integrity issues. Primary data entry and the mechanism used to record that is considered to be a primary documentary record, and all systems employed to ensure GMP compliance...