HOW TO PREPARE ANNUAL PRODUCT REPORT ACCORDING TO USP?

Annual product report (APR) is called another name is product summary sheet. It will contains total informations of product  regarding production, quality and vendor of RMs in a year. If you will prepare a APR, you will consider vendor information (suppliers name, RMS result, assay, exp date etc), Finished product ( must comply with all parameters of FGS and trend analysis FG result), production or process (change control, deviation, failrure insvestigation, out of specification etc. Information collected from respective BMR (Batch manufacturing record). APR is very important document of QMS.

Annual production report has created by accumulating data in the system and then could be expressed in chart comparison.