STANDARD OPERATING | ISSUE DATE: DEC 2018 | REVIEW DATE: PROCEDURE FOR EFFECTIVE DATE: | JAN2021 COMPLAINTS HANDLING | JAN 2019 aeaeee AND PRODUCT RECALL SRI BALAJI PHARMA LIMITED SOP NO: SOP/0057C SUPERCEDES SOP NO: _| SOP/005/B NAME DESIGNATION IGN | DATE WRITTEN BY: ‘NAOMI ASASILE QA. OFFICER ale REVIEWED B} NGETWA INNOCENT Q.C MANAGER Arty ‘APPROVED RY: ‘OKURUT MICHAEL HQMIQ.A MANAG SW ey PURPOSE: This SOP describes the procedure for handling complainth 4 product eal a ee, Net APPLICATION: All production, stores and QC areas WC Beco RESPONSIBILITY: It is the responsi personnel and to adhere to this SOP lity of production, warehouse Ruane ZANIA, DISTRIBUTION:: All Production units, QC department PROCEDURE ae ene ‘The complainant will fill complaints Form The complaints are forwarded to QA. ‘There is comprehensive handling procedure that covers product complaints. ‘The QA is responsible for following up the investigation and classification. The QA and Production jointly analyze the findings observed during the investigation critically and decide the corrective and preventive actions required to ensure non- occurrence of the problem in future. 6. The corrective and preventive action is done.(CAPA) 7. The whole process is documented in Complains file. 8. On investigation, if the batch is found defective, the batch is withdrawn (Critical-within 24 hours, Major and Minor- within 2days) PRODUCT RECALL ils a 5. The remain stock of the batch is segregated if any. ‘There is comprehensive product recall. The QA and Production jointly investigate the cause and take actions required for non-occurrence of such problem in future. ‘The recall of batch from market is coordinated by QA Letters are sent to all concerned distributors and stockiest 6. All batch recall records are maintained 7. The stocks are destroyed in presence of QA. Page 1 of 2 NO CHANGE SHOULD BE MADE TO THIS SOP WITHOUT THE WRITTEN CONSENT OF THE APPROVING AUTHORITIESSTANDARD OPERATING | ISSUE DATE: DEC 2018_| REVIEW DATE: PROCEDURE FOR EFFECTIVE DATE: JAN 2021 COMPLAINTS HANDLING | JAN 2019 eqperal AND PRODUCT RECALL SRIBALAJI PHARMA LIMITED ‘SOP NO: SOF/005/C SUPERCEDES SOP NO: _|'SOP/005/B NAME DESIGNATION psig DATE, WRITTEN BY: ‘NAOMI ASATILE (QA. OFFICER S ae ‘REVIEWED Bi NGETWA INNOCENT Q.C MANAGER ff 7 ass ae (2 APPROVED BY: OKURUT MICHAEL HQMiQ.A MANAGER, Abbreviations: SOP ~ Standard Operating Procedure QA - Quality Assurance QC - Quality Control HQM — Head Quality Management Page 2 of 2 NO CHANGE SHOULD BE MADE TO THIS SOP WITHOUT THE WRITTEN CONSENT OF THE APPROVING AUTHORITIESsit S SRI BALAJI PHARMA LTD ‘COMPLAINTS HANDLING SYSTEM. NAME OF COMPLAINT: ADDRESS: I = | PRODUCT BATCH NO. MFG.DATE EXP.DATE DATE COMPLAINT RECEIVED NATURE OF COMPLAINT CLASSIFICATION OF COMPLAINT(TICK) MINOR MAJOR CRITICAL CORRECTIVE ACTION DATE CORRECTIVE ACTION COMPLETED HOW WAS THE COMPLAIN HANDLED WITH CUSTOMER? SIGN AND DATE: QA MANAGER: