‘Fy Parmaceutical Guidance ope hm Stn SOP on Annual Product Review of Drug Product Quality ors 3y Prams E8tor om nary 18,7817 la QhAQE. Quay AssAN® SOP_No Comments + opjecrve + To establish a procaeure forthe preparation, even and approval ef Annual produt reviews to assure the consistent and acceptable quaty ofeach product manufactured fr dsr bon and apse upper management o ary changes neesed + RESPONSIBLITY: + ccer QualyAsturancet comple the dt or Annual Review ano prepare the annuarevew report + ead = Quay surance Deparment to approve the Annual Review Report ante ensure complanee “+ A batches shal be ined in the ovation. Satches in which manufacturing processes were changed during the edt shal be vluated separate, +The alenaryer nal be fom Januty to December. The inal Annual Review Report shal be avalabl with in sity (oy days ater the nd of eaten yor, + Te following analytical results shall evaluated forall batches: + Asay, ‘+ Content Usitormity high low, average and relative standrd vation) + soliton ate hgh. lm average) “+ mpurkyPofe 1 of maximum individual impurity and Wf ttl impure) “+ ocorsthe above detain format Evaluation finshed Product AnaljtaloattAnnesur) 1 Inprocess hoi dee: + elena Asa, + Average weight Lom, high and average) “+ Woigevariason Low. nigh, average ana RSD) + Physial parameters where appa suchas thickness ow, high average and RSD}, Hardness low igh average an RS). ‘+ facorsthe above detain‘ xalation ofn Process Analyt data’= Annexure = 2 + For each batch compile the theoretical ils obtained at ical stages tke blendng omression fll coating packaging ee. and of cneortical ld of tre batehin Evaluation of yield data annexure -3) + Prepare statistical wraphs or anya data and yes wherever appteasle + Curent values obtained and previous year vales stall be compared to determine the varion In patterns that could inlete ‘endencles or changes in proces. + Values obained shoul not fer signet from prevous yseraales, a signfian ierene or an abnormal patterns observed Inform tothe Production an RAD heads for investigation ‘te individu resus shal be win the approved specications + Genera ata +The annual Qual even report shall abo indude the lowing + stably data of batches which are kept on stably. 1+ Te reserve samaeinspecion reports wherever appieale “+ nvesvgmon reports of market complaints an produces + summary of dewatons ana non-contorming evens.+ Water system evaliaton: The punted water USP system shall be evaluatedin a yearly bass. The evaluation salle performed by evaluating miobolgal and chemical data compiled, The report shall Incude changes that occurred during the yar. + The Annual Prost Review Report shale approved by Head = Quay Assurance + Head - Quay Assurance shall rma the summary ofthe Behaviour of the procuet during the review petod to Head roduc, ead ~RRD, Head -Q¢ and Dison Hea ‘+The data shall be presented a5 fellows + Seaton (Coversheet) + Productname, Product code, nd ANDA numbers. + Manufacunng story nea: + Baten number, Baten sie Expiry te, pacing ype an units pe ack total umber of Batches, essed or recta or undesho Compile se nformation nthe format Evluton of batch data Uannexire + secon 1 end analyst neat “+ Assay, esluton, content unfoxmty weight aration, average weigh haraness hicenes yl, naj + exceptions neue “+ rvesgation reports of devitons ans non conforming events, 00S resus rom aberatary and podction, + sectons 1 staby toc: + Asummary ofthe stabi data and anahsiso problems or sessile problems. + complains include: + summary of mare: complains, both nical and guy. + secton? + Forms and Records (Annexures) + Specimen format af"Ealation of Fnsned Produc Analytical Data Annexure = 1 + specimen format of Evluavon of nprocess Arabs! data "=Annenure= 2 + Specimen formator"Ealuaion of Yall aa - Annexure: 3 + Specimen format of Bath date Annewute = + ierbution + aster copy = Quaty Assurance + Control copes Qual Assurance, Prosucton QualtyConralengnsering + story ate Revision Number Reason for Revision Specimen format of Evaluation of Finished Product Analytical Data” ANNUAL REVIEW OF RUG PRODUCT QUALITY ‘QUALITY ASSURANCEDesokton Content niormiy Impurity Profle Oe Teal eval ow High Stage Low High Average RSD npures specty Impurty Specimen format of Evaluation of Inprocess Analytical data” ANNUAL REVIEW OF DRUG PRODUCTS QUALITY (QUALITY AssuRANCE verage weet eign variation bards Osrtepraton| Thickness Baten Blend sup s No cures. Hah | tow average | High | low | average High | Low | Average | High | Low | Average | Hh | Low | Avene coats Specimen format of-Evaluation of Vield data" “ANNUAL REVIEW OF ORUG PRODUCT QUALITY of Moora! ld SNe, eatehNo, ate sie Coretablets) Coated Packet Specimen format of Bateh data ANNERURE <2 +“ANNUAL REVIEW OF DRUG PRODUCT QUALITY No.of arenes Manufactured ype vrPack Bate Status