enigl at aol.com
Wed Sep 25 00:34:27 EST 1996
In article <51t764$8hn at newsbf02.news.aol.com>, amarki at aol.com (Amarki)
>Subject: autoclave protocols
>From: amarki at aol.com (Amarki)
>Date: 20 Sep 1996 00:39:32 -0400
>Is it really necessary to maintain an autoclave log in a QA/QC
Yes, 100% required in a pharmaceutical company. There is no question.
FDA audits this 100% of the time and it will be an FD 483 observation.
You should also have a finished validation protocol on file. The ones I
usually write are 50-100 pages long with documentation proving the
autoclave is acceptable. Each load configuration is tested at least three
times (e.g., 3x liquids, 3x trash, 3x agar, etc.). Also, empty load,
maximum load, half cycles of each: all using a 10-12 multipoint
temperature recorder and 10 BI per load (triplicate).
The FDA will look for an IQ, OQ and PQ based protocol, as well as routine
challenge tests with BIs and hard copy charts of time and temp. of each
load. Each load must have a unique number as well as each batch of media
(media batch record). Traceability is required.
<<I am a new graduate with a degree in
>microbiology and just recently accepted a job as an associate
>microbiologist in a pharmaceutical company.
I can see from your question you have not been trained sufficiently for
FDA audits. Your company has the responsibility to train you. But, you
can do many things on your own. I suggest you read the CGMPs in the CFR,
the USP and the monographs given to FDA investigators on auditing
microbiology laboratories. PDA also has a monograph of autoclave
> I have worked with other
>laboratories who were either regulated by CLIA or EPA that do require log
>books for autoclave.
FDA is much stricter. You'll never know how tough audits can be until you
have been audited by the FDA. One time I answered 200 question in three
Davin C. Enigl, MS-MEAS, President-Microbiologist
HACCP Validations-sm Hazard Analysis and Critical Control Points for the
Food, Cosmetic, Pharmaceutical, and Nutritional Supplement Industry
Voice: (916) 989-8264, Fax: (916) 989-8205, Pager: (714) 725-7695
9040 Erle Blunden Way
Fair Oaks, CA 95628
September 24, 1996
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