FDA Annual Product Review (APR) Requirements

J

Jim-S

Hello,

I'm very concerned about how my company is currently performing Annual Product Reviews (APRs). I've been searching for information, samples, and/or guidances of what should actually be in an APR, but without much luck. Does anyone know of any references that I can utilize for my discussions?

Essentially the issue is that, in an effort to develop a more robust APR, we've gone severely off-track from what should really be in APR. We are now preparing bloated APR reports that quite literally conclude by saying the product is fine, but that we found a whole bunch of other problems and then list quality system observations which would normally be captured in an internal audit. For example, someone didn't follow the change control procedure, so one of our APRs concluded that the product was fine, but that we have a "systemic change control problem".

We are also going well beyond what we should for the APR. For example, I'm required to provide data on any change that was initiated, whether or not it was approved or implemented. In addition, we are required to attach copies of each and every document referenced in the APR. Every change control, every deviation, etc. This has resulted in a very time consuming effort that we don't have resources to maintain. I've written summaries for my department, only to have them re-written with out my knowledge and put in the APR.

There are many other issues with what we are doing, all of which result in a lot of work with little beneficial information coming out of it. I've tried to discuss the issue with the person in charge of the APRs, but they refuse to listen to any questions on the procedure that they've designed. We just continue to sign off on APRs which I fear are going to create major issues during our next FDA inspection.

I would appreciate any feedback and information that anyone can provide. Am I incorrect in my thinking on APRs?
 

v9991

Trusted Information Resource
I believe that your efforts/approach of arriving at 'product-specific' and 'system-specific' inputs from the APR sounds fair(as required and expected)

Emphasis is on "review" of various aspects of product such as trends on RM, PM, vendors changes, exceptions(incidents deviations/change controls), stability, complaints, returns-goods, CAPA, RCA, etc.,
, review to include the summary-trending/assessments.

attaching each and every exceptions report leads to redundancy.(potentially/possibly diluting the review part...)

justin case if you have not already seen these ....
http://www.bioqc.org/workshopdata/annual.pdf
http://www.qm-docs.com/downloadable/download/sample/sample_id/23/
http://qualityassuranceprocedures.blogspot.in/2010/12/annual-product-review.html
http://www.pharmamanufacturing.com/articles/2012/018.html?page=2
http://www.pda.org/Chapters/Asia-Pacific/Australia/Presentations/Annual-Product-Review-Developing-an-SOP.aspx

though, just an index, we could be inspired from it...
http://www.gmp7.com/annualproductreview_p9022.html

(infact, note that stage-3, continuous process verification of current process validation guideline, is actually furthering that monitoring/trending it online into batch release process...)
 

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