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Process Validation Protocol (API) as per new FDA Guidelines

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api (active pharmaceutical ingredients), fda (food and drug administration), fda requirements, validation of machines equipment processes design etc.
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  #1  
Old 8th March 2011, 09:39 AM
dinu344

 
 
Posts: 2
Please Help! Process Validation Protocol (API) as per new FDA Guidelines

Can anyody share Process validation protocol (API) as per new FDA guideline?

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  #2  
Old 8th March 2011, 08:48 PM
Marc's Avatar
Marc

 
 
Posts: 24,319
Re: Process Validation Protocol (API) as per new FDA Guidelines

Can anyone here help with this one? I have no ida what a Process Validation Protocol is. My Thanks in advance!
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  #3  
Old 8th March 2011, 10:01 PM
v9991

 
 
Posts: 803
Re: Process Validation Protocol (API) as per new FDA Guidelines

as per my first reading of new guideline, it has broadened the existing scope by
1)integrating process development + process validation (3-batches...)
2) introducing the life cycle concept of continuous monitoring (concurrent validation)

So, actually speaking, what we must be looking-for is,
First, revise the process validation SOP itself to introduce the above 2-points.
Second, at minute level, define the process capability/variability (to be established in Stage-I, verified at Stage-II, monitored at Stage-III as mentioned in guideline)
Third, Probably create a new SOP for continuous monitoring.



Note : pl. don't get carried away by the terminologies ...but take the essense of it; btw i may be just thinking aloud...And I am taking this liberty because, i haven't heard enough about implementation in the open domain (its probably still a paid seminars, consultant's domain, etc.,)
  #4  
Old 8th March 2011, 11:35 PM
Sam Lazzara's Avatar
Sam Lazzara

 
 
Posts: 212
Re: Process Validation Protocol (API) as per new FDA Guidelines

Here is the new guidance that I believe the thread leader is referring to....

http://www.fda.gov/downloads/Drugs/G.../UCM070336.pdf
Thank You to Sam Lazzara for your informative Post and/or Attachment!
  #5  
Old 9th March 2011, 07:58 AM
v9991

 
 
Posts: 803
Re: Process Validation Protocol (API) as per new FDA Guidelines

Here's another thread discussing on similar subject...

http://www.biotechlogic.com/pdf/TIDES.pdf

New FDA Guideline on Process Validation - General Principles and Practices
Thank You to v9991 for your informative Post and/or Attachment!
  #6  
Old 13th March 2011, 10:29 AM
dinu344

 
 
Posts: 2
Re: Process Validation Protocol (API) as per new FDA Guidelines

Thanks, for sharing the presentation.
  #7  
Old 11th April 2011, 09:43 AM
kristrainer

 
 
Posts: 4
Re: Process Validation Protocol (API) as per new FDA Guidelines

While the new Process Validation Guidelines were released in January 2011, they do not give specific information about statistical sampling plans for PPQs. Can anyone advise as to what method to use to sample liquids manufactured in 1000-3000 gallon tanks?
  #8  
Old 11th April 2011, 10:00 AM
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The Specialist

 
 
Posts: 317
Re: Process Validation Protocol (API) as per new FDA Guidelines

Quote:
In Reply to Parent Post by dinu344 View Post

Can anyody share Process validation protocol (API) as per new FDA guideline?

Is it a PQ example you are after?

Or, do you require a full 'life-cycle' package of documents (URS, VP, DQ ,IQ ,OQ ,PQ, VR)
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