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Companies go through two stages when they try to become compliant with FDA regulations. Stage one is to write all the procedures that translate the regulations into specific actions for the employees. That’s hard enough. In stage two the company has to get all its employees to follow those procedures. 
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FDA gives greater flexibility to drug makers than to Dietary Supplement manufacturers. Why? Moreover, the flexibility that FDA accords drug makers actually allows them to build better quality into their products than dietary supplement manufacturers.
Several times in this blog I’ve talked about the need to simplify business processes. In June I discussed how to 
Manfred Kets de Vries said, “First class people hire first class people. Second class people hire third class people. How do you put this maxim into action?
When FDA published its guidance document on process validation in 2011 it re-affirmed the importance of process development. This sounds like a lot of extra work for people who are barely managing IQOQPQ.
Is your workplace chaotic? Is everybody running in reactive mode? Does everyone acknowledge that it’s hectic, and then excuse it by saying, ‘We’re responding to our customers’. Yet, everyone knows that a hectic organization is a costly one, because rushing creates errors. Nothing drives up costs like an error prone business.
What do you see when you categorize the causes for your nonconformances? Does operator error account for more than ten percent? If so, you need to review your Root Cause Analysis system. You are risking an FDA citation. More than that, you are leaving money on the table.
Everybody has a favorite business metric. Read any best selling how-to manual and somebody will try to sell you an abstract parameter that will surely make you successful. All you have to do is tweak up that metric and your bonus will break the stratosphere.
Actually, no, you don’t. But you might want to know what the conditions are. First, you need to know the difference between validation and verification. Let’s review how FDA defines validation. From FDA's Guidance for Industry, Process Validation: General Principles and PracticesValidation & Compliance Institute
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