Hi All,
After finalization & publication of process validation new guidance document by FDA [Eff. Jan’2011], old guidance published in 1987 gets superseded.
New guidance having focus on product life cycle along with three major steps
Discussion invited in terms of changes to existing protocols & reports. What need to be further appended in the existing documents to have a “Pakka Document”.
Hi Siddhipharma,
How is it possible to go straight from Design to PQ.
Does that mean that no OQ will be acceptable in the future?
What about Charactisation and Test Method Validation surely they have to be a major aspect of the overall Process Validation Framework?
Regards
Hi gokeeffe,
I do agree with you, the qualification concept is still same i.e. DQ->IQ->OQ->PQ.
While we are talking about validations, a basic is Qualifications are come under umbrella of validation.
A littile bit elaboration is here:
Process design consist two stages i.e. A) Building & capturing process knowledge and understanding [Through development / Lab scale batches, existing product experiance] & B) Estabilishing a strategy for process control [in terms of CPP & IPQC etc.]
Process qualifcation consist major parts as
A) Design of Facility & qualification of equipment & utilities
B) Process performance qualification [B comprises A to ensure during / prior to execution]
Highlight : Increased focus on Utility Qualifications.
Happy reading !
For sure,
Charactisation and Test Method Validation only be part of process design stage.
As these are the basics for developing the Product design space.
Happy Reading !
Sometimes I feel guidance documents don’t really tell you anything new, and it takes a long time for this industry to adapt to new ways of thinking.
For new processes I think is it very easy for new techniques to be adopted but for existing manufacturing processes, the mentality is "If it ain’t broke don’t fix it!
In my experience there are many remediation projects that are nothing more than paper exercises to satisfy the regulatory bodies, do they really add any extra control to the process.
Performing a PQ on a process that has been running for 10 years doesn’t make sense!
If there’s a problem with process continual process monitoring should detect that.
Sorry rant over!
[quote=gokeeffe]Sometimes I feel guidance documents don’t really tell you anything new, and it takes a long time for this industry to adapt to new ways of thinking.
For new processes I think is it very easy for new techniques to be adopted but for existing manufacturing processes, the mentality is "If it ain’t broke don’t fix it!
In my experience there are many remediation projects that are nothing more than paper exercises to satisfy the regulatory bodies, do they really add any extra control to the process.
Performing a PQ on a process that has been running for 10 years doesn’t make sense!
If there’s a problem with process continual process monitoring should detect that.
Sorry rant over![/quote]
Agreed, guidance documents not giving any thing new, but these are compilation & a mutual understanding along with current thinking of agencies. Hoiwever these documents never bind someone to not use more scientifically justified techniques.
Well this was a good discussion on the Topic. Thanks for valueable inputs.
Mr Ashish & Mr.Graham,
I think we have to wait for the briefing on this from FDA.
There will be briefing on this in next 15 to 20 days.
There was an indication that OQ will become redundant or scrapped.This was briefed in year 2008 when they said they were comming with a Revised Guidance.
More effort is put on design , Control verifications and Risk based approach.
At present any one who looks it will not have a complete picture.
Regards
[quote=DURGA PRASAD]Mr Ashish & Mr.Graham,
I think we have to wait for the briefing on this from FDA.
There will be briefing on this in next 15 to 20 days.
There was an indication that OQ will become redundant or scrapped.This was briefed in year 2008 when they said they were comming with a Revised Guidance.
More effort is put on design , Control verifications and Risk based approach.
At present any one who looks it will not have a complete picture.
Regards[/quote]
Thank you Druga, it would be nice if they could be clear for what they require.
On February 17th there is a meeting in Berlin , Germany on this subject matter.
If you folks can read that guidance and put forth your questions on your behalf I can ask and get those replies.
I can take 3 best questions from this forum and put forward.
Regards
Finally the responses from Industry are comming very clear:
2.Performance Qualification or Stage 2 is confusing to industry right now. Does this attract the Validation process of Equipments like Autoclave/Drier/Tunnel/Tabletpress ect ? This padigram is still confusing industry. Does it attract the conventional qualification pocess of equipments or Not? Secondly when we look into Statistical Process controls they are now applicable fr both stage 1 and 2. This will enable industry move into a reality of stable process that is statistically analysed or proved or supported.
3. Process Verification or Stage 3: Much had been spoken about Subject Matter experts here and there is a scope for larger QA and process controls and stability process control in this particular area. FDA needs more supportive data on day to day processes.There is still a conusion zone whether it should be initiated in Stage -1 or only Stage -3. PAT will have its say in all 3 stages.
We are expecting this will be inducted officially with in 9 to 11 months.
A briefing is expected on 17th February in PDA meeting in Berlin and also on April 14 in Tampa Florida at ISPE meeting from FDA officials.
Regards
Thanks Mr. Durga for updates.
I had gone through the whole egg word by word. Actually this guidance is a compilation of understandings spread over the years since from 1987. Definitely work & design part is going to be increased much focused. Indusrties have to pay more cost. In addition to this old terminology of Process Validation -Prospective, Concurrent & Retro also had been removed from the guidance.
As you stated for 17th fab & 14th Apr we have to wait & watch, but meanwhile we have to tight our belts too to allign the current docs inline with new thinking…atleast for legacy products…
Happy Reading !