retrospective validation

Hi ,
I am preparing retrospective validation data for our finished product’s (Including tablets /Capsules /Liquids )my quiry is listed below :
-where to start I dont know about it ?
-Should we also study of Raw material ?
-if yes than which parameter should we include in our report ?

  • Besides trand analysis whats should we include ?
    -Is there any detail information in this matter ?

Pankaj Kr.sharma

It is nothing but APR.

For RM, u can incorporate the same with the Performance of Vendor. Normally we are not analyze RMs for each and every lot, when we get from a approved vendor.

U can incorporate
Production performance (details of all batches mfd.)
Production equip. performance
Change controls
Inprocess data
QC data

Along with trend charts u can use Mean charts and Range evaluation.

Dear forum,

Retrospective PV can only be accepted for established process espescially for non-sterile products. All information should include most information as normal validation process.

RM and PM information is considered important during assessment. Different RM manufacturer will supplied different type of RM even though it was from approved supplier. You should explain and justify it in risk assessment.

Then by using ‘Process Capability Index’ and ‘Sigma Calculation’ you should prove the data and critical parameters are consistent and capable to be produced consistently.