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FDA releases new Draft Guidance - Process Validation - Gen Principles and Practices

Ajit Basrur

Ajit Basrur

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#1
#1
FDA have released a draft Guidance document titled " Guidance for Industry - Process Validation: General Principles and Practices .

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
 
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Coury Ferguson

Coury Ferguson

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#2
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Re: FDA releases new Draft Guidance - Process Validation - Gen Principles and Practic

Thanks Ajit for this link.
 
bobdoering

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#3
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Re: FDA releases new Draft Guidance - Process Validation - Gen Principles and Practic

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

raghu_1968

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#5
#5
Re: FDA releases new Draft Guidance - Process Validation - Gen Principles and Practic

Thanks. I am in search of this.

Regards / Raghu
 
J

Juan Dude

#7
#7
Re: FDA releases new Draft Guidance - Process Validation - Gen Principles and Practic

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

Medical devices
Click to expand...
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?
 
Ajit Basrur

Ajit Basrur

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#8
#8
Re: FDA releases new Draft Guidance - Process Validation - Gen Principles and Practic

Juan Dude said:
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?
Click to expand...
I think there are not any major changes - any specific sections that you are think could conflict ?
 
J

Juan Dude

#9
#9
Re: FDA releases new Draft Guidance - Process Validation - Gen Principles and Practic

Ajit Basrur said:
I think there are not any major changes - any specific sections that you are think could conflict ?
Click to expand...
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)".

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.
 
W

Watchwait

#10
#10
Re: FDA releases new Draft Guidance - Process Validation - Gen Principles and Practic

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.
 
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