JOBS QUALITY RISK MANAGEMENT QRM Ni JODAS EXPOIM PVT. LTD. Department Cephalosporin Block @RA}M N17 loor-00 Equipment Instrument! System/ Process/ Utility/ Any Other Description of Risk: Risk associated with the usage of Sterile API without performing sterility test Material Page No.: 1 of 4 ‘+ Vendor evolution and assessment has been done as per procedure and found comply. ling of API into canisters under LAF at vendor sit, Receipt of material in intact ls Usage of Sion APL |e einisned product material basod|” sterity besheeesl onthe parameter may Filling of API into sterile and chemical test | fai Depyrogenated vials is ee pei undo Grde-A tested on the |* Opening of intact is Non-performing of API surrounded by Grade-B area miniature | onan APL Sei tes wth validated process. NA samples and | canister for Finished product samples are cereiderng | Sampling may Catlecng for stony and steritity product sterility performing the sterility test as parameter cae per approved analytical method fe Valsalon at sto ane co. ‘considering as finished product release parameter. '+ There is no further process of APL for formulation in finished product. J+ Vendor COA is available Format No.: QA052-F01-001s JODAS EXPOIM PVT. LID. QUALITY RISK MANAGEMENT Format No: QA052-F01-00 Department Cephalosporin Block Equipment! Instrument! System! Process! Utility! | jyaterici Page No.: 2 of 4 Any Other Description of Risk: Risk associated with the usage of Sterile API without performing sterility test ‘Summary and Conclusion: Based on the above assessment and current controls, risk associated with the usage of sterile API is low. Risk assessment Team Signature and Approvals Name Department Signature | Date | Qventorfe arcane aa SEA 9 100K. O06 2017 Nogue Reppy | __~propuetzon | web Redltz o7foeleort a ViReommtndva @xbd | plaar & preject, Cee OF feel ania Ye Resi tasnon | aD Roreinns'- eR 06} 3017 P- Love Retin Qc a, _ogtog fin. | 5 Meno Verte. Groiste | Qx Q OT ahradJGEBs QUALITY RISK MANAGEMENT ORM No. RA] Mm} im Joo2~8e JODAS EXPOIM PVT. LTD. Department Cephalosporin Block Equipment! rend ail Process/ Utility! | Material Page No.: 3 of 4 Description of Risk: Risk associated with the usage of Sterile API without performing sterility test Post Risk Mitigation Post Risk Mitigation Action Taken Severity Occurrence Detectability Roe e a Format No.: QA052-F07-00J JUALITY RISK MANAGEMENT QRM No.: oni Berom ev. 0. a QRAIM 1 Jooa-co Department Cephatosporin Block Equipment! era eae Process/ Utility! Material Page No.: 4 of 4 Description of Risk: Risk associated with the usage of Sterile API without performing sterility test. ‘Summary and Conclusion: Post Risk assessment Team Signature and Approvals Name Department Signature Date SN wel Ss Bine 5 ~~. Format No: QA052-F01-00