quality period). Manufacturing review. Product review pertaining to manufacturing

qualityreview.WarehousereviewProduct  review pertaining to warehouse should includethe following:List of all startingraw materials and packing materials use for the product.Review of all rejectedraw materials and packing materials if any.Review of all Approvedvendor list (it includes list of all critical raw materials/packing materialvendors qualified for the review period).Manufacturing review.Product reviewpertaining to manufacturing should include the following:List of All batchesmanufactured, number of batches reprocessed/reworked, number of batchesrejected and number of batches cancelled.An overview ofmanufacturing process(specific to product) like product description and processflow diagram.Review of criticquality process parameters.Trend analysis ofmanufacturing yield/batch yield/packing yield.A trend of variablecritical process parameters/quality attributes identified during validation ormonitoring protocol.Hold time reviews suchas bulk hold time , filling time and total processing time.Qualitycontrol review.Laboratory phase reviewshould include the following:Overview of processcontrol designs for identity , strength, quality and purity.Review and trendof  critical API test results, in bothmanufacturing and packing process Laboratory incidentsoccurred for the review period.Review / summary ofstability studies.Evaluation of processcapability index for bulk and finished product stages.Review of allanalytical method validations.Engineeringand maintenance review:Review of manufacturimgarea classification.Review of preventivemaintenance and calibration of all relevant equipments/ instruments and utilities Review of all  equipments involved in manufacturing andpacking.Review of qualificationstatus of equipments and utilities eg., HVAC, water,compressed gases etc.QualityManagement systems review.Review of alldeviations  and subsequent investigationsrelated to material, preventive maintenanace, calibration programme,manufacturing process, testing process and packing process along withcorrective and preventive actions.Out ofspecifications/Out of trends investigations along with CAPA.Summary of all marketcomplaints, product recalls, quality retuned returns etc.Review of Qualitytechnical agreement/contractual agreements.Review of all majorchange controls and effectiveness of CAPA.Recommendations andconclusion of previous PQR report  andsubsequent CAPA if any