posted 01 August 2001 02:26 AM               

From: Nancy Jennejohn
Date: Tue, 31 Jul 2001 10:19:42 -0500
Subject: Re: GMP /../Ennis/Wyke/Ennis

From: "Norm Ennis"

> From: "WYKE, JOHN"

> Norm Ennis wrote in part:
>> It seems that the typical medical industry company thinks that
>> experience with a GMP company is absolutely required for
>> someone coming on board. I know that a previous background
>> is good thing but the level of paranoia is much higher in
>> the medical field than aerospace companies or even companies
>> that make equipment for NASA. I have no idea why. Quality product
>> is quality product and with all the issues over the chicken and beef
>> industries it can not be health related.

> Norm,
> The level of 'paranoia' is higher in medicines because many of them are
> taken by vulnerable people who are in no position to judge the quality of
> the product. Imagine if your immune system is shot (I don't know, Chemo, for
> example) and you are prescribed some medicine. You can't opt out and be
> 'vegetarian' like you can with beef- if that product is contaminated, you're
> in trouble. In the UK the medicines act 1968 which controls production of
> medicine, was brought in after some catastrophic effects on consumers.
> Rather than branding us a paranoid, maybe other industries could use a
> healthy dose of it.
>
> Apologies for straying off topic slightly. That said, I reckon that GMP
> backed up with ISO9001 is a fairly bombproof QMS (as long as everyone's on
> board). It certainly makes our Qualified Person sleep easier before License
> assessments...
>

----------

First a precursor comment. I would like to respond to John's comment to clarify myself. But I also feel that this may be a more common issue than with just the medical industry.

The issue I address here is that good people may not be reviewed for jobs because they do not have multi-years in that specific job. Is that not the original concept of ISO 9000. If the rules are in place and being followed, then people of a certain minimum training can properly fulfill their jobs in a correct manner. The GMP is a document like ISO. It says to put procedures, etc. in place to ensure that the product is correctly made, tested, packaged, etc.

John,

The quality of the product is critical. NO problem. But are you telling me that a company dealing with the GMP never makes a mistake? That bringing in a veteran Quality Engineer who may not have spent 20 years working with the GMP makes that person not qualified to read the procedures, GMP, etc. and understand and follow the system in place?

My point is this. I have worked in Quality for many years. When I started working with NASA man-rated systems ( 60% of the product was tested-to-failure so the remaining 30% can be used one time then thrown away) (six million pounds of high explosive depending on 100% correct system operation) I was not looked down upon because I did not have 7 years working with NASA specs. I was expected to read the specs, understand them, and apply them in the manufacture of my product.

However, when I talked to a few people at a medical production facility (they made the plastic parts for medical needles and tubing ) you would think that I had a disease. I have even previously reviewed the GMP so I could make a recommendation (to a previous company) as to what additional efforts we would have to add if we decided to make a fax machine that tied into a medical monitoring machine.

My point is that I feel many of the management and higher ups in medical companies are paranoid with out good reason. Do these actions indicate that maybe management does not really have a solid understanding of the GMP and its requirements so they look for someone who has experience as a way of proof of knowledge.

I also have to wonder about all the meat packing companies and their operations. Are they covered by the GMP? Is there any correlation between the many exposé's that have been done on the poor quality and general unhealthiness of packaged meat and the government oversight by the FDA of meat quality.

So is this just a medical company issue? Are there other type companies that have the same type reaction to a lack of previous experience? Has anyone else experienced this with medical companies?

Sorry about the length and I don't mean to make this personal. I am curious about the aspect of this "need" to have prior exact experience though.

Just my two cents worth. Norm