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Part 4 was added to 21 CFR, effective July 22, 2013. This is a new regulation, intended to help identify and clarify which rules apply to Combination Products. It provides regulatory framework and defines which Parts of 21 CFR apply to facilities that manufacture single-entity or co-packaged combination products. In the past manufactures of Combination…

We left off in Part One, with spiraling costs for commissioning and qualification activities. Some companies, under regulatory pressure, would perform a full IQ/OQ for commissioning, then a “dry-run” IQ/OQ, and then the “real” IQ/OQ. That is three full qualification efforts! Even with all this expensive paperwork, the startup experience was rarely improved. Generating, approving,…

Risk management is a growing discipline within the Life Sciences industry.  With the introduction of FDA’s 21st century GMP and ICH initiatives (such as Q8 Pharmaceutical Development, Q9 Quality Risk Management, and Q10 Pharmaceutical Quality System), drug manufacturing entered a new era of risk management. There is now an expectation that organizations have a high…

There was a fantastic post on the Harvard Business Review Blog Network today. It validates everything we have been preaching for years here at Automated Systems Inc.  The article takes American business to task for its false assumptions about well educated, older workers. The article states: Then there’s a set of employer beliefs about workers…

In the good old days, when I was a field service engineer, I tested things.  Anything I didn’t test, usually came back to bite me.  A piping & instrumentation diagram and electrical/pneumatic schematics, along with a good highlighter, were typically all that was needed to ensure that everything was tested and that a working system…

FDA warning letters are always interesting reading. Typically, these warning letters describe quality systems which, despite good intentions, have gone awry. However, sometimes the warning letters are simply shocking.  This is the case with this letter recently sent to Wockhardt.  It’s hard to know where to begin with this one, but let’s start here: For…

Finding talent for our life sciences clients makes up the majority of my work day.  At ASI we evaluate talent the old fashioned way; we talk to candidates, their peers, and their employers.  We look for knowledge of first principles, energy, drive, integrity, good judgment and good character.  In contrast, it seems many of our…

I recently received an email from the ISPE.  The email asked the following question: “If the FDA asked you tomorrow, “How do you define quality?” how would you answer?  How would you prove your answer? One way to ensure product quality is to define it as an industry, a definition that until now has not been explored.”…

The Wall Street Journal At Work Blog has an interesting post today.  The post related to salary negotiations, but I believe it applies to audit responses as well. In a nutshell, the sited study claims that numbers with more significant digits convey credibility and understanding, while rounded numbers seem arbitrary and not well thought out. …