Vitek System

enigl at aol.com enigl at aol.com
Sat Nov 23 13:53:34 EST 1996

In article <3295ECE2.A6A at worldnet.att.net>, Biomorphic.tx at worldnet.att.net

>. I would consider valid results 
>from these QC runs as validation.

No way.  That does NOT satisfy an FDA inspector. What you describe is
merely "daily" QC, not validation.   A validation consists of IQ, OQ, PQ. 
Installation Qualification, Operational Qualification and Performance
Qualification.  I give talks sponsored by bioMerieux Vitek and include
part of one of my "Validation of the Vitek System" talks here:

You need to validate your Vitek system.  I sell a $600 Vitek Validation
protocol. It's about 50 pages long:  

1.  It's made up of organized IQ, OQ and PQ sections required by the FDA.
2.  Each topic (IQ, OQ, PQ) is presented in clear, concise easy-to-follow
lists and page selections easily modified on your word processor.
3.  It gives you straightforward validation procedures and information
4.  You can locate the answers to the FDA investigators questions so they
can absorb it with maximum efficiency and minimum of searching.
5.  My validation  protocol will save you time and trouble.

What kinds of things are in my Vitek protocol?
1.  The acceptance criteria of the validation.
2.  The equipment needed to be validated. 
3.  Installation requirements.
4.  Operation requirements list such as SOPs, training documentation,
calibration records.
5.   Performance requirements such as acceptance criteria for correct
6.   Routine quality control and re-validation schedules.
7.   Computer verification documentation and source code availability.
8.   Dealing with the FDA investigator.
9.   Legal requirements for validating ID systems.

Onsite training is available.  General validation "How to"  presentations
are available.  I have given several sponsored by bioMerieux Vitek.
Validation of the Vitek System for Pharmaceuticals
By Davin C. Enigl
Revised: January 26, 1996.


1. 	Title Slide: This presentation was originally given at the Vitek
meeting in Irvine, California in December 1995 and was written by Davin
Enigl, senior microbiologist at Watson Laboratories, in Corona,
California.  Watson is one of the largest producers of generic drugs in
the United States.

2.	Definition of Validation: This definition is used by the FDA and
validation is required by CFR (Code of Federal Regulations) in at least
two aspects: 1. Vitek is classified as a medical device and Vitek is used
to ensure product quality for manufacturing of pharmaceuticals both are in
Title 21 of the CFR.

3.	Why Validate equipment?: Besides the regulatory requirements, we
have some practical reason to validate equipment. These are illustrated
here.  Why validate a wheel?  Because nobody ever believe new inventions
will work until you PROVE IT.

4.	Validation Team: The people involved in validation are listed. 
The user of the equipment is the microbiologist.  The technicians would
not usually be assigned to validation and would use the equipment only
after it has been validated and training has been taken.

5.	Written Protocol to Validate Equipment: This is usually written by
the validation section of quality assurance with the help of the

6. 	Installation Qualification: ---SNIP---

7.	Operation Qualification:  ---SNIP---

8.	Performance Qualification: ---SNIP---

9.	Software qualification: ---SNIP---

10.	Software Life Cycle Phase testing: ---SNIP---

11.	Software Validation Phases: The last on the list is most important
to the microbiologist because it is like a performance qualification Vitek
has improved the reliability of the system. 

12.	Protocol Outline: These 9 steps are the parts the FDA looks for in
validation protocols.

13.	Purpose: ---SNIP---

14.	Application: ---SNIP--- 

15.	Abstract: ---SNIP--- 

16.	Performance Accuracy: The most important step is the PQ,
Performance Qualification.  Accuracy and the next slide: Reproducibility.
Three challenges are performed.  One with the Vitek recommended QC ATCC
bacteria, another with other ATCC not QC recommended and finally,
---SNIP---  Each can have differing acceptance criteria.  For instance,

17.	Reproducibility: ---SNIP---

18.	How far do you have to go?:  ---SNIP--- You can perform a HACCP,
hazard analysis of your products and process and decide what to validate
at each critical control point. In some cases it is important to

Other Microbiology Technical Services and Training:

FDA current (pharmaceutical) good manufacturing practices, cGMP 
Pharmaceutical microbiology technical services
Validation Protocols for pharmaceutical water systems and laboratories

Current Good Manufacturing Practices (cGMP):
FDA Regulations and Plant Audit Help

Equipment validation protocols: 
Incubators, Autoclaves, Identifications Systems (such as Vitek®) 

Water systems: protocols, microbial control, design and validation: 
HACCP Validations  for Water Systems, WFI and PW-USP

Critical Control Point environmental monitoring: 
HACCP Validations for the Pharmaceutical Industry

Product Formulation, with and without preservatives

Microbiological Shelf Life and Stability validation

Rapid (D-value) and USP Preservative Efficacy Testing research and

Nutritional Supplements Efficacy, Toxicology, USP 23 CGMP, validation,
protocols, SOPs and Quality Assurance

Laboratory Start-Up: Validation, SOPs, Test Methods and Training

Water Activity Testing: aw

Resume' and publication list available on request.
Davin C.  Enigl, MS-MEAS
HACCP Validations   Hazard Analysis and Critical Control Point Validations
9040 Erle Blunden Way
Fair Oaks, CA 95628
(916) 989-8264 Voice and Voice Mail
(916) 989-8205 Fax
(916) 687-6347 Pager Northern California
(714)72507695 Pager Southern California
Wed Site:  http://members.aol.com/enigl/index.html

November 23, 1996
10:39 am

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