Process Validation Protocol (API) as per new FDA Guidelines

[kristrainer]

We sample the outer areas of the tank at top, middle and bottom. If we can show that our samples meet %RSD for homoegeneity, do we need to increase number of samples? Worst case scenario samples are collected by collecting at the outer areas. We could separate into quadrants and sample, but we are talking about solutions.

 

[The Specialist]

We sample the outer areas of the tank at top, middle and bottom. If we can show that our samples meet %RSD for homoegeneity, do we need to increase number of samples? Worst case scenario samples are collected by collecting at the outer areas. We could separate into quadrants and sample, but we are talking about solutions.

How much historical data do you have for the process (with ref. to sampling)?

How many samples (at-once) were taken during the process qualification/validation stage?

Is there a period during manufacture where the liquid is not agitated?

It seems to me that the auditor is not confident that you are able to prove homogeneity of mix based on your current sampling plan. What additional information do you have in support of your sampling plan that may address his/her concerns?

 

[kristrainer]

Several liquid products are manufactured here and the batch record calls for continual mixing throughout the steps of manufacturing and throughout the packaging process. Samples are collected at the beginning , middle and end of packaging process also. Packaged product testing is compared to bulk product testing and must meet a % RSD . We are discussing the sampling of the quadrants at the top and bottom of the tank and some random sampling in the middle. The increase in samples will overwhelm the QC lab, but if the auditor accepts this it will probably be the route we take.

Thank you for your advice.

 

[raghu_1968]

Any updation on this topic. Did anybody started implementing as per the new guidance.

Specifically interested on the validation approach (as per the process validation new guidance) towards low volume API products.

Thanks

 

[abdullah.alhg]

hi am abdullah al-haj a newly registrated member in elsmar forum....
i would like to ask about process validation for in-vitro diagnostics what kind of process validation do i need to conduct concerning in-vitro diagnostics?

thanks alot
best regards
abdullah...

 

[v9991]

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...

Process Validation A Lifecycle Approach : http :// www .fda. gov/downloads/AboutFDA/CentersOffices/CDER/UCM255585.pdf - OBSOLETE BROKEN 404 LINK(s) UNLINKED

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

http :// www .lmi.no/media/2852497/process_validation_jarle_a_haugan_gehc.pdf - OBSOLETE BROKEN 404 LINK(s) UNLINKED

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

What is Process Validation? :- http :// www .pda. org/Chapters/Asia-Pacific/Australia/Presentations/FDAs-Process-Validation-Guidance-12-May-2011--Presentation-Three.aspx - OBSOLETE BROKEN 404 LINK(s) UNLINKED

Top 10 Changes : - Top 10 Changes in FDA's Process Validation Guidance - BioProcess International

The Life Cycle Approach to Process Validation :- http :// www .islyophilization .org/Html/Local_Chapters/Midwest_Great Lakes/Midwest_2012_Conference/Presentations/4_Hal_Baseman.pdf - OBSOLETE BROKEN 404 LINK(s) UNLINKED

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

 

[saisai]

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

 

[v9991]

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.

 

[v9991]

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

https://www.ispe.org/discussion-papers/stage-2-process-validation.pdf
https://www.ispe.org/discussion-papers/stage-3-process-validation.pdf