New FDA Guideline on Process Validation - General Principles and Practices

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somashekar

Staff member
Super Moderator
#2
Re: New Guideline - Process Validation

FDA has released a new Guideline on Process Validation titled "Process Validation - General Principles and Practices" in Jan 2011.

.
Pasting a part of the introduction here to highlight what it covers and what it does not cover, for the interest of other visitors.
This guidance covers the following categories of drugs:
•Human drugs
•Veterinary drugs
•Biological and biotechnology products
•Finished products and active pharmaceutical ingredients (APIs or drug substances)
•The drug constituent of a combination (drug and medical device) product

This guidance does not cover the following types of products:
•Type A medicated articles and medicated feed
•Medical devices
•Dietary supplements
•Human tissues intended for transplantation regulated under section 361 of the Public Health Service Act
 

Ajit Basrur

Staff member
Admin
#3
Re: New Guideline - Process Validation

Somashekhar,

Thanks for highlighting - this Guideline is applicable for Pharmaceuticals and not Medical Devices !
 

v9991

Trusted Information Resource
#5
Whats more interesting is the impact of the life-cycle approach outlined in the document.

Stage 3 – Continued Process Verification: Ongoing assurance is gained during routine production that the process remains in a state of control.
....

Manufacturers should:
•Understand the sources of variation
•Detect the presence and degree of variation
•Understand the impact of variation on the process and ultimately on product attributes
•Control the variation in a manner commensurate with the risk it represents to the process and product


(apart from validation procedure itself) It will certainly have impact on current procedures of annual product review, raw material supplier qualification, quality control processes etc.,

btw, has anybody started looking into impact/implementation of this guidance?
 
Last edited by a moderator:

v9991

Trusted Information Resource
#8
Curious to find out...if i am missing some obvious rationale/references for following queries!!.

1. while exclusion of 'medical devices' & 'human tissues' is explained through reference to separate GHTF&CBER documents respectively, what is the rationale for excluding on "Dietary supplements" from the scope!

2.What/which tools are most appropriate for characterizing the "variability" at various stages of "Design-PPQ-Commerical manufacturing"? (although brief reference is made to ASTM documents E2474, E2476,E2500)

3. ARe there any case studies available to learn by example/experiences!
Here's one i got from net; but then thats just a ppt...http://www.biotechlogic.com/pdf/TIDES.pdf
 

v9991

Trusted Information Resource
#9
there is another aspect of the PV guidance...
stage-1 Process design : offsets another significant change...
1. Building and Capturing Process Knowledge and Understanding
...Risk analysis tools can be used to screen potential variables for DOE studies to minimize the total number of experiments conducted while maximizing knowledge gained...
2. Establishing a Strategy for Process Control...


IT has laid out the expectation of risk assessment, DOE, PAT tools etc., and further, the process development report has been part of the dossier submission; but now it becomes part of the PV and hence essentially part of the routine audits ...
 

v9991

Trusted Information Resource
#10
:read:

Can validation be value adding activity...
http://www.cmcbio.com/bioinnovation2010.pdf

FDA's New Process Validation Guidance: It's as easy as 1,2,3
http://www.expresspharmaonline.com/20100228/expressbiotech14.shtml

Detailed Analysis of FDA´s New Process Validation Guidance
http://www.gmp-compliance.org/eca_news_2380_6764,6864,6917,6971.html

The New FDA Process Validation Guideline
A focus on the life-cycle approach ushers in a new area in the GMP field.
http://pharmtech.findpharma.com/pha...ideline/ArticleStandard/Article/detail/662356
 
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