• 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 […]

  • 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 […]

  • 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 […]

  • Should we be using iPhone video procedures?

    The following post was written by Dr. Nigel J. Smart, Vice President and Managing Partner at Smart Consulting Group.  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 […]

  • 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 […]

  • 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 […]

  • WHO Ebola Vaccine Meeting

    So what’s with all of the buzz on Ebola vaccines and how will it impact the future of this outbreak? The overwhelmingly and ever increasingly amount of buzz surrounding Ebola is undeniable. Although this is not a new concept or topic of discussion in the news room, there seems to be no letting up as […]

  • 483 Audit Forms

    So what’s with this 483 audit form and where do I go from here? Faced with a 483 audit form? If this is the first time your company has received a document of this nature your initial thoughts may be… now what? In order to understand the true implications of a 483 citation, it may […]

  • Bottlenecking Theory

    Bottlenecking Theory Lean Biomanufacturing, by Dr. Nigel J. Smart Understanding this theory can help address key concepts that can help your research team yield optimal results. It’s important to begin your research by first running through some equations that will help your team throughout your experimental endeavors. After all, you wouldn’t read a book if […]