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Enigl enigl at aol.com
Sun Jan 18 21:54:30 EST 1998

In article <69jp0h$bhv$1 at nntp.Stanford.EDU>, "Barry Lifland"
<blifland at leland.stanford.edu> writes:

> One needs to clearly define "validation"
studies - as any knowledgeble
>microbiologist with good bench level
experience in diagnostic work knows -
>organisms can change. . .  If the refered to
>test used the same isolate on the
same lot of media the same day, run by the
>same tech and got 10 different ID
s, that could be significant.

Validation has only one definition (by U.S. CFR law) for cGMP FDA compliance: 
Validation is the process of performing SQ, DQ, IQ, OQ and PQ protocols
successfully where the equipment is proven to function as designed.  

In the case of an ID system, the PQ part of the protocol will end up being
about 50 pages of documentation of reproducibility and accuracy using ATCC,
environmental isolates (and "house isolates) and the recommended BIOLOG QC test
organisms (also ATCC, different one than the first ATCC test).  BIOLOG has not
passed these tests (yet).

<<Biolog and Vitek, using them in different areas of their

I hope it is not one of my clients.  Yes, some "have" the BIOLOG and are
struggling with it--fighting with the FDA over the use.  Some clients are also
struggling with Vitek--validation is not easy.  Even API havd a problem and has
been FD-483'ed.

<< As far as I know, GLP regulations/guidelines only require that
the things be validated. I know of no FDA "approval" needed...>>

FDA has to "approve" (that means no unacceptable answers to FD -483 questions)
of the  protocol.  BTW it's not "GLP,"  that is a different regulation--for
safety studies, not manufacturing quality/assurance control.  The
validation/regulation I am talking about is actually "cGMP"--for manufacturing
quality/assurance control.

<<To date: NO one method is suitable for all identifications. Any micro lab
attempting ID’s must use a variety of systems and methods, or they will get
incorrect identifications sometimes, and maybe a lot of times.>>

That is true, but the "claims substantiation" part of the PQ validation
protocol _MUST_ be acceptable up to the designed false ID probability level. 
The FDA "recommends" a backup method  (they also never really "recommend"  (nor
as you correctly say, "approve") anything either).

Davin C. Enigl,  Microbiology Consultant,
MEAS-Master of Environmental Arts and Sciences.

1.  Discovered heat resistance in mold: _Talaromyces trachyspermus_ (Published

2.  Co-author (with Kent M. Sorrells), Water Activity and Self-Preserving
In:  _Preservative-Free and Self-Preserving Cosmetics and Drugs_, Kabara and
Orth, editors.  Copyright 1997,
Marcel-Dekker, ISBN 0-8247-9366-8, Telephone: 1-800-228-1160

3.  Water System Design and Validation for FDA regulations

4.  Preservative Formulation and Stability Testing

5.  FDA Validation Protocols: aseptic, sterilization, laboratory methods

6.  Hazard Analysis and Critical Control Points (HACCP)

7.  Current Good Manufacturing Practices (cGMP)  Audits

Web Site:  http://members.aol.com/enigl/

January 18, 1998
7:48 am PACIFIC
Davin C. Enigl, MEAS. Microbiology Consultant for Foods, Cosmetics,
Pharmaceuticals and Biotechnology. FDA validation protocols, water system,
autoclave, facility start-up. Author: _Preservative-Free and Self-Preserving
Cosmetics and Drugs_ Marcel Dekker.

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