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Go Back   The Elsmar Cove Forum > National and International Business Standards and Requirements > Food and Drug (Pharmaceuticals) related Regulations > Qualification and Validation (including 21 CFR Part 11)
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Process Validation Protocol (API) as per new FDA Guidelines - Page 3


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Related Topic Tags
api (active pharmaceutical ingredients), fda (food and drug administration), fda requirements, validation of machines equipment processes design etc.
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  Post Number #17  
Old 1st September 2012, 07:15 AM
v9991

 
 
Total Posts: 819
Lurker Re: Process Validation Protocol (API) as per new FDA Guidelines

so, at-last found something on net....about guidance in implementing a process(steeps, procedures...) for new process validation guideline.

hope this helps....I am delighted to have seen the light at the end.
particularly glad that our inhouse approach is almost 80% matched to that outlined in the document there.
i feel extremely lucky and proud to give away the trick and tip...
just search the term "process validation stage 2" and "process validation stage 3"
and look for ISPE reference...(pdf file)


here' are few other usefull references...

http://www.pda.org/Chapters/North-Am...alidation.aspx

Process Validation A Lifecycle Approach : http://www.fda.gov/downloads/AboutFD.../UCM255585.pdf



New approach to API process validation in light of ICH Q7-Q11 :-

http://www.lmi.no/media/2852497/proc...augan_gehc.pdf

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



What is Process Validation? :- http://www.pda.org/Chapters/Asia-Pac...ion-Three.aspx

Top 10 Changes : - http://www.bioprocessintl.com/journa...uidance-316535

The Life Cycle Approach to Process Validation :- http://www.islyophilization.org/Html...al_Baseman.pdf

Developing a Sound Process Validation Strategy :- http://www.biotechlogic.com/pdf/BioPharm-reprint.pdf

Last edited by v9991; 1st September 2012 at 01:09 PM.

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  Post Number #18  
Old 30th October 2012, 02:13 PM
saisai

 
 
Total Posts: 27
Re: Process Validation Protocol (API) as per new FDA Guidelines

hi, All,

Is there requirement to say the expiration date of IOPQ report ?

after the first time IOPQ protocol, when will need to re-validate again? after one year?

thanks
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  Post Number #19  
Old 30th October 2012, 02:21 PM
v9991

 
 
Total Posts: 819
Re: Process Validation Protocol (API) as per new FDA Guidelines

IOPQ in itself doesn't have any expiration dating!!!
Yet it can be revised/updated whenever there is significant change to spare parts/ modifications done to the equipment itself. (like you have added additional/advanced controls, or any part has been upgraded etc)

however, there is a re-qualification criteria defined as per your internal procedures. wherein you would take stock of the breakdowns, calibrations, preventive maintenance; changes, spare parts etc.,and where required actually perform the re-qualifications by running required tests.

in short, you would have addendums to IOPQ reports which are updated at pre set frequency.

Last edited by v9991; 30th October 2012 at 08:26 PM.
  Post Number #20  
Old 6th June 2013, 02:03 PM
v9991

 
 
Total Posts: 819
Look! Re: Process Validation Protocol (API) as per new FDA Guidelines

http://www.ispe.org/publications/discussion-papers

https://www.ispe.org/discussion-pape...validation.pdf
http://www.ispe.org/discussion-paper...validation.pdf
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