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Re: Technical Writing in the Manufacturing Industry: Supplements, Cosmetics, OTC

Subject: Re: Technical Writing in the Manufacturing Industry: Supplements, Cosmetics, OTC
From: "Peter Neilson" <neilson -at- windstream -dot- net>
To: techwr-l -at- lists -dot- techwr-l -dot- com
Date: Tue, 22 Jul 2014 13:06:56 -0400

Gene's on target. My wife used to work in an FDA environment. Labeling, for example, was according to strict regulations. Every label had a serial number, and had to be accounted for. Unused labels had to be returned. Spoiled labels had to be logged and destroyed. Unless the FDA has lost its marbles, that sort of fussy stuff is still in place. Getting it wrong is supposed to get you fired.

On Tue, 22 Jul 2014 12:25:52 -0400, Gene Kim-Eng <techwr -at- genek -dot- com> wrote:

FDA regs are Title 21CFR (Code of Federal Regulations). You'll find requirements for documentation under each part (laboratory, manufacturing, etc.). The parts you will probably be most interested in are 11, 58, 101, 104, 111 and 170.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm

There are some very specific requirements for control and storage of records. See part 11. DITA and other actual authoring tool decisions will be the least of your worries.

Gene Kim-Eng


On 7/22/2014 8:19 AM, Kyle Simmons wrote:
Just landed my first tech writing gig in the quality control department of
a midsized manufacturing company. We produce dietary supplements and are
regulated by the FDA. I want to learn more about industry-specific tech
writing practices because there's so much regulation surrounding our
products. When I look for information about tech writing and manufacturing,
I find a lot about electronics and consumer-facing documentation. I'm
dealing with foods, packaging, compliance, and internal documentation. Does
anybody here work in a similar industry and have some advice for someone
who's just getting his feet wet? And more specifically, any recommendations
for document management/control (I was thinking a long-term goal of
transitioning to DITA)?


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References:
Technical Writing in the Manufacturing Industry: Supplements, Cosmetics, OTC: From: Kyle Simmons
Re: Technical Writing in the Manufacturing Industry: Supplements, Cosmetics, OTC: From: Gene Kim-Eng

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