Author: Nigel J Smart PhD

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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Companies, People, Strategies. How to Align all Three to Assure success?

In any industry sector, but specifically that dealing with Life Sciences one is faced with the constant challenge of how to align all these three components to generate significance added value in a compliant and efficient way. Although strategic plans are hierarchical in terms of their DNA, it’s the tactical implementation of these that will ultimately make the difference both in terms of technical achievement and financial bottom line. The transition/transformation of technical ideas to that practical implementation is not always straight forward, not the least because organizations often don’t take the time to inform and obtain buy-in from...

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New Leadership Principles for Manufacturing in GMP Facilities

Leadership in today’s environment is becoming a more complex proposition than it has been in the past. With the availability of newer technology and a workforce that perhaps does not follow traditional top down edicts, like in the case of previous generations, finding a path that enables quality decisions to be developed and implemented is more challenging. What’s required is an integrated approach of technology and employee action. Looking at employee contributions, today, more “shop floor” engagement is required, where well trained and educated staff provide greater input and take increased responsibility for the job functions and deliverables. In...

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Managing Data and Documentation for FDA GMP Inspections.

Managing inspections is a very nervy process but if planned out carefully may not be as daunting as often believed. Part part of the reason there are problems, is down to the fact that companies do not have a good organizational plan. This is a key point which can make or break the inspection experience. Given its importance, the plan should have a structured level and set out clearly what documents should be helpful. It’s a good idea for the inspection team to have a pre-meeting or series of meetings to go over the key points that might be...

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