FDA have released a draft Guidance document titled " Guidance for Industry - Process Validation: General Principles and Practices (http://www.fda.gov/cder/guidance/8019dft.pdf).

The following categories of drugs are within the scope of this guidance:

Human drugs
Veterinary drugs
Biological and biotechnology products
Finished products and active pharmaceutical ingredients (API or drug substance)
The drug constituent of a combination (drug and medical device) product

The following categories of products are not covered by this guidance:

Type A medicated articles and medicated feed
Medical devices
Dietary supplements
Human tissues intended for transplantation regulated under section 361 of the Public Health

Thanks Ajit for this link.

Are you aware of a Guidance for Industry - Process Validation: General Principles and Practices for Medical devices?
It would be handy...:cool:

Are you aware of a Guidance for Industry - Process Validation: General Principles and Practices for Medical devices?
It would be handy...:cool:

GHTF/SG3/N99-10:2004 offers guidance.

Thanks. I am in search of this.

Regards / Raghu

Are you aware of a Guidance for Industry - Process Validation: General Principles and Practices for Medical devices?
It would be handy...:cool:

Chapter 4 of the FDA Quality System Manual (http://www.fda.gov/cdrh/qsr/04valid.html) covers Process Validation for devices.

The following categories of products are not covered by this guidance:

Medical devices

FDA's Guideline on General Principles of Process Validation from May 1987 DOES cover Medical Devices under it's scope.

This leaves me wondering many things, but mainly: can the old guideline still be used as such for medical devices?

FDA's Guideline on General Principles of Process Validation from May 1987 DOES cover Medical Devices under it's scope.

This leaves me wondering many things, but mainly: can the old guideline still be used as such for medical devices?

I think there are not any major changes - any specific sections that you are think could conflict ?

I think there are not any major changes - any specific sections that you are think could conflict ?
Not necessarely conflict, other than the fact that the new validation guidance scope is only for drugs and Medical Devices are suddenly left out of the scope of this new guidance due to the non-participation of the FDA's Center for Devices and Radiological Health (CDRH) in preparing the new guidance document (the old guidance did cover Medical Devices under it's scope).

According with the new guidance it turns out that:
"The 1987 guidance was prepared by a working group that included representation from the Center for Devices and Radiological Health (CDRH). Since that time, CDRH elected to publish its own process validation guidance through the Global Harmonization Task Force. The principles and recommendations in that document, Quality Management Systems – Process Validation, edition 2 (available on the Internet at http://www.ghtf.org/sg3/sg3final.html (http://www.ghtf.org/sg3/sg3final.html))".

Note the correct link is: http://www.ghtf.org/documents/sg3/sg3_fd_n99-10_edition2.pdf.

What all this means is that the above referenced GHTF validation guidance is also in fact the FDA's official validation guidance for Medical Device Manufacturers.

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.

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.
Sounds interesting, would you please elaborate for us not familiar with this recent Utah Medical ruling?

Sounds interesting, would you please elaborate for us not familiar with this recent Utah Medical ruling?

I believe it's this (http://www.outsourcing-pharma.com/Clinical-Development/Utah-Medical-victory-in-FDA-legal-dispute)...

Stijloor.

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.

Sounds interesting, would you please elaborate for us not familiar with this recent Utah Medical ruling?

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.

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

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
DOE is a great statistical tool to optimize processes/machines with multiple operating settings.

Thanks. Is there any standard book for this?

Regards / Raghu

Thanks for this link.