Author: Jeff Gignac

Quality Standards, India?

Problems continue with the quality standards at manufacturing plants in India. This time it’s Sun Pharma that appears to be in trouble with the FDA imposing a Warning Letter for operations at the company’s Halol facility. During the FDA inspection more than 20 manufacturing quality violations were noted. What does this mean for the Long Term viability of India’s generic industry? With so many company’s now under some form of restitution and/or import ban will America consumers start to exert their buying power to demand drugs from reliable sources? Furthermore, where does this leave American Pharmaceutical companies that are sourcing these products from Indian companies? Are they in danger of a consumer...

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Lean Biomanufacturing: Keeping Your Eye on the Quality Goal

By Nigel J Smart PhD, Smart Pharmaceutical Consulting To some, Lean Manufacturing is a meaningless concept when one is considering medical therapies or medical products. Often there is confusion in common English language, where the emphasis is on the Lean & Mean interpretation associated with just being efficient. As we all know this is a big misconception associated with our terminology and unless we pay attention then there is a real danger that we will miss the boat and create something that’s going to hurt our companies and the industry as well. Lean manufacturing in medical products, which should include but need not necessarily be limited to pharmaceuticals, vaccines, biotechnology products and medical devices is all about producing the highest quality products for consumers. As already noted, this is frequently missed out when one talks about Lean because out culture is often heavily geared towards the efficiency component. This is naturally understandable in a highly competitive global market where cost, time to market and short cycle times play such a critical role in the success of a product. However, with that being said, the focus on product quality has at least as much an impact on success because this is so tightly bound with product safety and the eventual successful deployment of the product as a medicinal agent. The social responsibility associated with making a safe medical product is...

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The Pharmaceutical Consultants Role in Lean Manufacturing/Biomanufacturing Processes

By Nigel J Smart PhD; Smart Pharmaceutical Consulting. So you’ve decided to run a Lean Manufacturing Program at your site, and you’re thinking how best to organize and operate the program. One useful option is to enlist the assistance of an experienced Lean Consultant. Here are a few areas where a consultant can play a useful role in your program: As a sensei, the consultant can provide an objective overview of the situation and Mentor the Lean team and workforce into why it’s important to do things in a certain way. The whys, the where’s and the how’s of the situation are examples of where a Lean consultant to can play a significant role in your program. As an experienced extension of your team the consultant can quickly run a diagnostic assessment of key processes, gaps and weaknesses associated with your Current State and can get you tracking quickly. Deciding what tools to use and how to use them and provide the largest bang for your buck is also not always immediately apparent, so to have a Lean consultant that knows the pharmaceutical industry will speed up your process and help to deliver tangible results using the most efficient deployment of your resources. Relative to this, the consultant will take pressure off the line management during the difficult process of culture change that is often required to produce a...

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Leachables and Extractables in Biopharmaceutical Processing

With the burgeoning interest in the use of disposables for the production of modern biopharmaceutical products, the level of scrutiny surrounding the topic of Leachables and Extractables has moved into a higher gear. It seems that there is an endless amount of attention being paid to this topic because of the potential impact on patients receiving biopharmaceutical based therapies. As a result, there is a frantic level of regulatory activity as scientists attempt to predict and quantify whether there’s any regulatory impact, particularly as it relates to safety. Although issues connected with Leachables and Extractables has been discussed for over 25 years, the recent trend towards the use of new disposable methods of production which includes; wave bags, disposable plastic bioreactor inserts and their myriad of associated tubing and samplers, means that the probability of some elastomer eluting from the components or alternatively some breakdown product washing off the material might be much greater. With the potential for both Leachables and Extractables to have a marked effect on the quality and safety of protein therapeutics, the challenge is therefore on to find better testing methods to provide an adequate level of sensitivity and specificity that will assure both quality and safety concerns are met. Similarly, provider companies are looking at newer materials that may not have the same potential contaminating profile which might reduce or minimize the problem. With...

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