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FDA releases new Draft Guidance - Process Validation - Gen Principles and Practices

J

Juan Dude

#11
#11
Re: FDA releases new Draft Guidance - Process Validation - Gen Principles and Practic

Watchwait said:
In light of the recent Utah Medical ruling, I'd think that FDA would want to revise (the old 1987) medical device validation guidelines in accordance with the outcome of this ruling. Medical device manufacturers now have more than one path to validation compliance & it would make sense to document alternative approaches to compliance.
Click to expand...
Sounds interesting, would you please elaborate for us not familiar with this recent Utah Medical ruling?
 
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M

MIREGMGR

#13
#13
Re: FDA releases new Draft Guidance - Process Validation - Gen Principles and Practic

Basically, the FDA said "we expect you folks to follow the same rules as everyone else", and Utah Medical's defense was "we should be allowed to run our operations any way we want, as long as you can't prove that our products have hurt someone".

The judge ruled that Utah Medical's stance was correct because the rules were too complicated for him to understand.

What it indicates to me is that we need a better set of standards for who is qualified to be a judge.
 
Ajit Basrur

Ajit Basrur

Staff member
Admin
#14
#14
Re: FDA releases new Draft Guidance - Process Validation - Gen Principles and Practic

Juan Dude said:
Sounds interesting, would you please elaborate for us not familiar with this recent Utah Medical ruling?
Click to expand...
Refer http://www.in-pharmatechnologist.com/Industry-Drivers/Utah-Medical-victory-in-FDA-legal-dispute

A federal US judge set a precedent last week in ruling against the US Food & Drug Administration (FDA) in a four-year dispute against Utah Medical Products.

The landmark ruling has industry-wide implications for all medical device and pharmaceutical companies regulated by the FDA, and may inspire other companies to launch future legal challenges against FDA's regulative authority.

Reacting to the decision, Utah Medical CEO Kevin Cornwell said, "After a long ordeal, we believe the court has vindicated Utah Medical's quality system."


At issue was a disagreement over how the company sought to meet Quality System Regulation (QSR) requirements in the areas of adequately validating its manufacturing process, validating its software and uniform complaint handling process.


The FDA alleged that Utah Medical was non-compliant, and filed a lawsuit in August 2004 to shut down the operation of Utah Medical's facility in Utah, until they complied with the FDA's interpretation of the QSR, an interpretation that was never provided to Utah Medical until after the lawsuit was filed.


The Court, however, disagreed with all allegations by the FDA, and has now dismissed the lawsuit, citing no evidence of Utah Medical's products as being unsafe, ineffective, defective or causing any patient harm.


In summing up, federal judge Bruce Jenkins acknowledged that the QSR of Utah Medical's products was never in question and described the FDA's case as "extended and in some instances 'nitpicking.'"


He criticised the general nature of the FDA's regulations themselves, which he described as having the virtue of generality and the vice of imprecision.


"This endemic problem is perhaps augmented by decision makers who themselves rely too much on inspectors' reports without taking a fresh look themselves at ongoing changes made by Utah Medical in response to questions raised," commented Jenkins.


FDA spokeswoman Julie Zawisza said the agency's guidance documents and regulations did allow for broad interpretation of good manufacturing practices (GMPs).


"This is a landmark decision that clearly shows that medical device companies need to comply with the relevant regulations, not the subjective demands of FDA personnel," said Dan Jarcho, attorney for McKenna Long & Aldridge, who represented Utah Medical.


"This ruling is a common sense breath of fresh air that affirms that regulated companies can turn to the courts when the FDA refuses to act fairly," he said.


Utah Medical Products, with particular interest in health care for women and their babies, develops, manufactures, assembles and markets a broad range of disposable and reusable specialty medical devices.
 
R

raghu_1968

Involved In Discussions
#15
#15
Re: FDA releases new Draft Guidance - Process Validation - Gen Principles and Practic

I am interested to know that did any body started applying this new guideline concepts. I wanted to know about the tool Design of experiments which is mentioned in this guideline.

Regards / Raghu
 
J

Juan Dude

#16
#16
Re: FDA releases new Draft Guidance - Process Validation - Gen Principles and Practic

raghu_1968 said:
I am interested to know that did any body started applying this new guideline concepts. I wanted to know about the tool Design of experiments which is mentioned in this guideline.

Regards / Raghu
Click to expand...
DOE is a great statistical tool to optimize processes/machines with multiple operating settings.
 
R

raghu_1968

Involved In Discussions
#17
#17
Re: FDA releases new Draft Guidance - Process Validation - Gen Principles and Practic

Thanks. Is there any standard book for this?

Regards / Raghu
 
M

mukteevi

#18
#18
Re: FDA releases new Draft Guidance - Process Validation - Gen Principles and Practic

Thanks for this link.
 
R

ricky07

#19
#19
Re: FDA releases new Draft Guidance - Process Validation - Gen Principles and Practic

have you heard of the "validation life cycle" concept? if so, is there a summary top level "map" of the validation activites associated with Supplier-product-decomminishing?

thanks.
 
M

michaeldlq

#20
#20
Re: FDA releases new Draft Guidance - Process Validation - Gen Principles and Practic

Thx for your sharing. But "Page Not Found"
 
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