Author: Nigel J Smart PhD

How to successfully navigate the FDA site inspection process

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...

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Pharma 4.0 and what it really means for the Production of High-Quality Pharmaceutical Products

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...

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The Importance of Good GMP Documentation & Data Entry

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...

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Is a Standardized Approach to Improving CAPA Performance Required?

The challenge for quality in manufacturing pharmaceuticals is a constant battle. The need to institute policies, maintain good operating procedures and assure personnel are appropriately trained in all of these is onerous. Taking a risk managed approach adds to this level of complexity even though it helps assure a reduced risk of failure, like a kind of added insurance type approach. All these features are designed to improve quality with the belief that with a greater degree of management oversight there will be a greater degree of accountability, and with that, improved quality performance. And yet if one looks...

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The Use of Artificial Intelligence in Improving the Quality and Efficiency of Pharmaceutical Processes

In addition to the Quality Management System approach and application of risk principles, a way to stay proactive and ahead of the evolving compliance curve is to create a system to appropriately manage knowledge and data sets, pertaining to a given task, function or mechanism. Access and fast recall of information and data sets permits a different type of awareness, and it’s this mindset that enables your strategy and operational tactics to assure there is real-time action. This action, based upon timely and appropriate information availability, is vital to maintain systems and peak state. Many Current State systems operate...

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