pharmaceutical production

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I have a software company which automates engineering test documents. We have dozens of clients in the pharmaceutical field.

Here's an interesting fact about pharmaceutical production lines: they are required by the FDA to be thoroughly tested and documented as to their ability to produce, label, and package their drug products properly and consistently.

The testing process, called 'validation', is difficult, expensive, and time-consuming. And, it has to be repeated whenever significant changes are made to the production line. If it is not done properly, or if the validation shows problems, then the FDA can, and will, shut down the production line.

The upshot is this: fixes to 'embedded systems' in pharmaceutical manufacturing have a much higher regulatory burden of testing and documentation than similar repairs elsewhere, and will in fact take longer.

The obvious ramification here is interruptions in our drug supply.

This problem is just now coming into focus for a lot of pharmaceutical engineers. I'm starting to ask questions of my customers. I'm getting guarded answers.

Can anyone else out there shed any light on this subject?

-- Brady Wiseman (BradyWiseman@compuserve.com), May 21, 1998

Answers

I recently posted what I learned about storeage of humalin insulin. I spoke to Lilly pharmaceuticals this week and they said "we expect to be in production in 2000". I can assume that's the same as 'we're working on being compliant in 2000, but we can't guarantee it.'

-- Carol Baum (cbaum@lycosmail.com), September 07, 1998.

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