This is not a chromatography question but since a lot of FDA regulated people use HPLC, I thought this was as good of a place as any for my question. My new supervisor, who has a pharmaceutical background, has apparently told some people that the six sigma control process can be used in place of batch testing. I have been told he has said the pharmaceutical industry uses this and only tests on an audit (occasional) basis. This goes against what I thought I knew about FDA regulations but since I do not work in an FDA lab, I thought I'd check with people who do and might know if this is correct.

It is critical that you try to transfer away from this supervisor. Individual batches are required to be released!!! I suspect that your supervisor has had too many doses of whatever his company made. Getting too close to a person with such wacko beliefs can only reflect poorly on his entire team. Run Fast unemployed.

My company makes WalMart/Target/etc.-sold OTC pharmaceutical products (non-consumed products)and every batch is tested and three OTC stabilitytesting is also done. There are laws regulating these things, either follow the law or get out of the pharmaceutical business in USA.

If you don't follow your boss, you could be out right away; however, if you don't follow FDA guideline, you will have a job at least until next FDA audit!

Can you tell me where your supervisor came from so that I can be sure not to take any of their medications.

Your boss is confused - although 6 sigma may be used as a quality indicator. You might want to take a look at parametric release although I suspect your company processes will not have been validated and are not controlled to justify this.

Thanks for the information and comments. As I mentioned, we are not an FDA regulated company. Our products are EPA regulated and EPA does not require GMP. However, the claim has apparently been made that the pharmaceutical industry uses 6-sigma process control instead of batch testing. I suspected this was overselling and from the comments I have gotten, this appears to be correct. We have unfortunately been concentrating on accuracy of results instead of telling people what they want to hear. I suspect this may be one of the reasons the company is interested in eliminating batch testing, and the lab. Perhaps it is felt it allows credible deniability. In addition, it appears testing is considered a hindrance to production schedules. A comment has been made here about our future as a chemical Enron! That would probably not be considered to be a positive attitude.