Author: smartc

MAKING THE CASE: The Imperative for Life Sciences Companies to Integrate Corporate Compliance and Quality Compliance

In its simplest form, quality is about making sure that the products offered by a company are safe, effective, and meet the requirements of the prevailing regulations around good manufacturing methods. Corporate Compliance is about making sure that the company operates in a safe, effective manner and by doing so creates loyal, satisfied customers who want to continue doing business with the company. Despite the simularities of objectives, most life sciences companies treat Corporate Compliance and Quality Compliance (“Quality”) as separate disciplines, and provide limited opportunities for natural synergies to flourish. However, for a life sciences company to be competitive and sustainable in this era of increasing regulatory complexity crossing traditional national boundaries this must change; Corporate Compliance and Quality Compliance must become an integrated team that works together seamlessly. Read MAKING THE...

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Best Practices of Smart Consultants

A fresh, new start…a brand new you? What kind of consultant are you and who would you like to be in 2015? As we approach the last week of the first month in 2015, if you’re like us, you may have done some self-reflecting, both professionally and personally over the last several weeks. New Year’s resolutions might be in full swing or could have possibly even been forgotten by now. A major question people ask themselves each New Year is: Who do I want to be in 2015? As a pharmaceutical consulting company, we encounter a vast array of personalities within our client/business relations. From there we began to ponder: What kind of consultants do we consider near and dear to our heart? Is it the cruise ship director? The person who is likely to sit back and watch their team assign roles and work for each other while they help to boost the overall team’s morale? Although keeping it positive is an amazing and sometimes hard to find trait among people in this industry, there is more to the job than being the team cheerleader. Don’t be a cruise ship director this year! If the person above sounds a lot like you, perhaps it’s time to get a bit more hands-on in your consulting work in 2015. Refine and sharpen your skills. Focus on having more of an...

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Should we be using iPhone video procedures?

The following post was written by Dr. Nigel J. Smart, Vice President and Managing Partner at Smart Pharmaceutical Consulting.  With the increasing complexity of operational procedures, the use of traditional standard operating procedures must be questioned, particularly for equipment or technique operation. The use of photographic techniques, pictures and other illustrations were long advocated benefits in other industries, yet the pharmaceutical industry continues to cling to practices that were right for the 1940-50’s. Other industries have long since moved on and so should the pharmaceutical industry. Use of modern video records, diaries and commands should become the new accepted practice bringing our industry into the 21st century. Scientific studies prove that these types of tools are much more effective in assuring that processes are properly operated compared to written procedures which frequently collect dust on the shelves. Perhaps the time is right to be more interactive and progressive about the way we communicate instructions for our processes, particularly since almost everyone has a smart phone more commonly today than a wrist watch, for example. The old adage that pictures are worth a thousand words is true in our industry and very relevant when communicating across numerous languages. As a final word, we should not hide behind the excuse that these are not controlled records like SOP’s since we have the technical capabilities to address this issue without it becoming a...

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Consolidation Activity in the Generic Sector

Consolidation within the generic industry continues to occur at breakneck speed through merger and acquisition activity. Multiple major players are engaged in not one but several mergers simultaneously, a fact that’s perhaps confusing to some people on their respective supply chains. Integration activities often spawn their own issues as organizations with quite different cultures are fused together to blend product portfolios. These do not often fit easily and new strategies need to be developed to assume that products will remain available to consumers at the right price. As producers drop out, monopolies are developed and the Federal Trade Commission is obliged to step in to protect competition and consumer choice.  This involves its own level of management which can also put stress on the company to deliver products to the consumer. So beneath the economic/business surface news of an acquisition/there’s the underlying practical considerations which may be overlooked by the financial people, which include how we are going to make these products within the new fragmented supply chain. Inevitably there will be delays under the present strategy, but perhaps there’s a better way to look and plan for the Future State before it arrives unexpectedly in your back...

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SCG’s thoughts on the last 10%

For the Pharmaceutical industry, it is difficult for consumers to tell the difference between an excellent, acceptable or poor quality product.  For this reason, safety, quality and reliability problems can go undetected  until the FDA detects them during an inspection or after investigation for a product recall.  By then, the problems can be out of control and can result in a Warning Letter or Consent Decree. The below excerpt can be found here: “ Seth’s Blog: The tragedy of the last 10% In a competitive market, if you do the work to lower your price by 10%, your market share grows. If you dig in deep, analyze, re-engineer and make thoughtful changes, you can lower your price another 10%. This leads to an even bigger jump in market...

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