|. Deputy General Manager, Plant 1. Manager, Quality assurance oP nan’ Pe = 8 Manager, Engineering Deputy Manager, Product Development Assistant Manager, Production Senior Executive, Quality Assurance Senior Executive, Engineering Senior Executive, Quality Control Executive, Microbiology Executive, Warehouse Executive, Human Resources . Archive Copy4 | f [ SOPIPEN-OA/021104 | 32 324 3.22 323 324 325 326 327 328 PURPOSE ‘To provide a documented procedure to establish the procedure for the rejection and destruction of matenials (Raw materials and Packaging materials, Intermediate Products, finished goods, retention sample and Materials used by PD activities, QC & Microbiology) when they declared ‘aS unfit for use after approval. SCOPE ‘This SOP is applicable for rejection and destruction of materials (Raw materials and Packaging materials, Intermediate Products and finished goods, retention sample and, materials used by PD activities, QC and Microbiology) of Opsonin Pharma limited, Penicillin production building, RESPONSIBILITIES Head of QA, QC, PD, WH, Production and Microbiology is responsible to raise the rejection form. Executive/ Sr. Executive, QA Logging the rejection form with reference number in logbook. Receive investigation report (report generated from investigated team) it decision of rejection. | is not made through deviation and change control. Participate and verify the rejected materials during destruction. Take approval of rejection trom Deputy Managing Director or Managing Director Issue “Rejected” Label and ensure every containers has its status label, Avchiving of rejection documents in QA after destruction Keep tracking rejection materials in destruction logbook. Transfer the amount of rejection material from respective storage area to NCR Store or Blocked area through software, pray ‘admin for account and VAT clearancer OMT esosanveronatIVITINONIUVNIOOMTUTITINIOTITOTUTTOTTLTD TE TET 352 BD 35.4 355 356 357 Seftle he replacement issue with suppliers repare the lst of rejected malerak Tov approval rom Depuly Wanaging Decor Director for destruction. Retum the recommended returnable material to commercial Arrange rejected material for physical destruction in presence of QA, HR and Admin. | Handover rejection document to QA after destruction for archiving. Head of Admin of His Nominee Arrange destruction of rejected materials. Participate and verify the rejected material during destruction. Head of QA or His nominee Team formation to investigate the rejection if decision of rejection is not made through Deviation & Change control. Verify the material to be rejected Check the list of rejected material for destruction Ensure that every rejection must commence used on investigation report Recommend for the approval of the rejected material for rejection. Recommend the list of rejected materials for approval from Deputy Managing Director or Managing Director for destruction. Inform Head of commercial (if applicable) about rejection of the rejected materials (Raw or Packaging Materials) Head of MRP or Planning | Give clearance for destruction Head of Commercial or His Nominee Inform the supplier about the rejection Give instruction to WH to return the material, approval from Deputy. ‘Managing Director or Managing Director for the destruction of noia] te Bie [ Feces Dat | Review ue HT A : Deputy Managing Director or Managing Director } Give approval for rejection on any further investigation is required before final approval, Approve the list of rejected material for destruction. 4. TRAINING REQUIREMENTS Executive and above all 5. ASSOCIATED DOCUMENTS Nil 6. ABBREVIATIONS AND DEFINITIONS SOP — Standard Operating Procedure QA Quality Assurance | QC Quality Control PD Product Development RM Raw Material PM Packaging Material WH — Warehouse DGM Deputy General Manager DMD Deputy Managing Director MD Managing Director Rejected materials: All materials (Raw and packaging materials, bulk and intermediate product, finished product, PO trial material etc.) failing to meet established specification are | Identified as rejected materials. This may include material, which is surplus to requirements, material of uncertain status, or matenal at any stage of manufactuiring process and compoenets, which is unacceptable for any reason such as identifed as Quality defect during ‘quality incident reportinon-confirming products, recalled product, material used for PD activities,75 76 77 82 83 84 Ensure that each rejected container is labeled with rejected label in reject store. Ensure that only approved rejected material is being disposed gf & properly documented. Printed packaging material should be destroyed in the factory premises and no retum of printed packaging material allowed. Carry out the sorting of the identified defective printed packaging materials (if required) in the factory premises (warehouse) in a controlled separate visible area and it should be done in presence of WH or QA personnel Store the rejected material under lock and key in the rejected store until destruction. Destroy all rejected material including printed packaging material within the factory. Use safety goggles, hand gloves, rubber boots, mask, protective cloth, Helmet ete during destruction of the material are required PROCEDURES: Raise (respective departmental head) a rejection form (appendix A) along with all information and signature in the section -1 of appendix A and handover the form to QA. Put (QA) a refernce number for rejection record as follows and Keep record in the log book (Appendix -8) — Abbreviation of Rejection along with numerical serial number/ last two digit of the cutrent year e.g PEN-REJ/001/17, here PEN for Penicillin Production building, Form (Head of QA) a cross functional investigation team for rejection (Which is not made through deviation, change control) with the set time for report submission ‘Submit (investigation team) a formal investigation report (Appendix D) for rejection describing the background, root cause of incident & propesed preventive action ‘Venty and give signature (Head of Quality Assurance) in the section -2 of Appendix A ‘Take (QA) recommnedation from Deputy General manager, Plant the section- 2 of Appendix- A Block (Head of QA) the rejected amount through software and issue the hold label for physi | ; | 1h i } Aare i HIpan = 8.10 B11 8.12 8.13 814 8.15 B16 Handover (QA) the documents to warehouse immediately. Issue (QA) the rejected label and ‘ensure every container of rejected container has been labeled. Inform (Executive, WH) to head of commercial about the rejection through Email. For semi finishedfinished goods/discontinued or expired materials rejection inform Head of MRP, Planning and concemed department and except these inform head of commercial through email. Attach a copy of the email with rejection form Appendix A (section 3). Transfer the material to reject store Keep (WH) the labeled rejected matenals (container/bag/pack) in the reject store in warehouse Maintain the log book (Appendix-C). Prepare (Executive, WH) alist of rejected materials (RM/PM other than expired or discontinued RM/PM) and share to head of commercial for clearance for destruction. Also prepare a another list of rejected materials (Semi finished/finished,/Expired/Discontinued RM/PM) and share to QA for destruction approval from DMD/MD as applicable. Communicate (commercial) with supplier about the rejection and setile the replacement or retum issue Inform (Head of commercial) to warehouse through email to send the materials to commercial department with proper documentation for replacement if settled. Keep record of retuned materials in section 4 of appendix A Give (Head of Commercial) clearance for destruction of rejected materials after settlement replacement or retum issue with vendor and inform to warehouse and concern department. ‘Take approval for destruction of non replacement and valuable items from DMD and inform to warehouse for destruction Keep (Sr. Executive! Executive, WH) a copy of retum mail for destruction clearance in the rejection fle Prepare (Sr Executive/Executive WH) a Separate rejected material list for destruction approval || from hese Of quality assurance (ater getting clearance from Commercial that the material is mu ail addiduvtatatakrantatraotavahil (habvguael ar a contaminatediil i OTTO TT —— oo i TT Tan Sonn i at 821 822 823 8.24 8.26 827 2.28 8.29 8.30 8.31 8.32 Prepare (Sr. ExecutivelExecutive, WH) separate rejecected ‘maternal ‘lst a clearance from commercial) considering the commercial value i.e. cost benefit ratio, feleced. materials without replacement for approval from Head of quality assurance for destruction, Inform the accounts about the rejection and take custom clearance after getting approval of destruction for rejected materials if required. Perform safe destruction of all rejeceted materials within six months after getting approval from, Head of quality assurance (Section- 6) Record the variation (if any) found during destruction with proper reason in section -7 of Appendix A Carry out the destruction in presence of person from following department and take signature of the attendance in section -8 appendix- A = Quality Assurance = Warehouse - Commercial (site) - HRD & Admin (site) Scrap (Head of QA) the rejected material through software Prepare (WH) quarterly report on updated list of rejected materials and send to Head of Quality Assurance and copy to Head of commercial, Head of MRP. Keep (QA) the quarterly report of rejection material status in QA Tile. Carry out of an intemal audit of all rejected area at least once in year Send (WH) the rejection document to QA after destruction of rejection for archiving Archive (QA) the rejection document in QA after destruction Destruction of rejected materials (Raw material/ Packaging material) 8.32.1. Raw Materials (Liquid) 8.32.2 Raw Materials (Solid, Semi-solid and Powder) — Liquid material rejected should be diluted by suitable quantity of water and collected in container and transfer this material to ETP plant, ~ || Solis, semisolid and powder rejected materials shouls be destroyed by maki _Walet and transfer his material to ETP plant, aenitNOL 833 8331 833.2 8.34 8341 834.2 SOPPEN-ONO2II0N || IM ec Hi I a T Hl | HL "Rejected Giass matenal (Ampoute, Vil Hote a) shoulibecnhin a mad this material to incinerator. WH WHT — Rejected printed packing material (Inner carton, Leaflet, Shipper Cartan etc.) should be ‘destroyed by tearing into pieces and transfer this material to inciverator for destroy. = Rejected roll of Aluminum fol, PVC & PVDG film should be bored al three diferent places, 0 that its integnity was lost and transfer this material to incinerator for destroy. = Rejected plastic container should be crush and transfer this material to incinerator for destroy Destruction of Intermediate/ Bulk Product. Tablet, Capsule, Solid and Powder Products — Contents are collected in container by de-foiling and crush these in a drum and dissolving in sulficient quantity of water and flash out this matenal in drain of ETP Plant Packaging Materials are transferred this material to incinerator for destroy Liquid and Semisolid Products — Contents are collected in container from bottle or tubes and diluted by suitable quantity of Water and flash out this material in drain of ETP Plant — Packaging Materials (Bottle and tube) should be crush in a drum and transfer this material to incinerator for destroy Destruction of Finished Products ‘Transfer the rejected Solid finished products to incinerator for destroy Liquid and Semisolid Finished Products _ Contents are collected in container from bottle or tubes and diluted by suitable quantity of ater and flash out this material in drain of ETP Plant Packaging Materials (Botte and tube) should be crush in a drum and transfer this material to incinerator for destroy. |E__ Rejection Label (Appendix E) 10 CHANGE HISTORY DATE REVISION DESCRIPTION OF CHANGE 10 Jurts, 01 Original DocumentNo sai i of ste Date | Efocdve Dat w Due iii rnin : TT REJECTION NO.: PEN/REJ) ‘SECTION 1: DESCRIPTION OF REJECTED MATERIAL Name of rejected material: i Ttem code: BatchQc Ref no ‘Quanity: Manufacturer name Deviation/Out of specification/Change control refe required) No. of Cont” Supplier name erence no /others (Attach investigation report if Reason for rejection: Rejection raised by Name Designation: i iil Signature and date Tnvestigation required TRAE No Responsible for investigation Tin Estimated time’ Head of Ai (Sign & date) Time extension (Wrequired) Reason for time extension Investigation team Head of QA & Date) {Sign 8.0bte) Report submitted on fit : hi Wilh 4 i} Lith CUE TY j LA TH[SECTION 3: Copy of email to commercial deparimenUMRP from Executive warehouse ‘SECTION SCRIPTION OF RETURNED MATERIALS Name of retumed materials: Quantity returned: Supplier name Date of return’ Batch no Gate pass no, Ratumed by (Signature & date) St. Exetutive/Executive Warehouse “Received by Receiving person (Signature & date) Copy of e mail from Commercial/QA to ware house for clearance for destruction | SECTION|S| APPROVAL FOR DESTRUCTION (Comments if any) Head of Quality Assurance Deputy General Manager, Plant METRE TTTSolid, & liquid: Tablet/capsule/granules/powder for suspensioni/sterile powder for injection! Empty capsule shell dilute with water & drain out Foil and PVC film: by cutting into pieces then send to incineration Empty glass botile/ampoulevial By crushing and send to incineration/salvaged yard. Syringe/needie/measuring cup/bottle: Deform by crushing and send to salvaged yard Packaging material (inner carton, leaflet, label): tear off and send fo salvaged yard ‘others Date of disposal Disposal time: From to Quantity disposed ‘SECTION 7: VARIATION (If any) Variation found if any reason’ SECTION 8: PERSON MEET DURI |G DESTRUCTION Department Name Signature’ Dateae area Bere nv LOGBOOK FOR MATERIALS FOR REJECTION AND DESTRUCTION (QA) Batch no/ac. Ref. no. Quantity, ‘00S/ Deviation? other reference | Reason for rejection no, Rejection ‘no. enter by __ Designation Signature Executive, Quality Assuranc 7 [Si executive, Quality Assurance LAE | SHE HtLOGBOOK FOR MATERIALS FOR REJECTION AND DESTRUCTION (WARERHOUSE) Code no, Name of |] Batch no /ac i Received date ‘material ret. no. | Quantity | Reject on | ar reject store | Checked PY iT Signature | AL HARE AME AM‘ ‘TEMPLATE FOR INVESTIGATION REPORT Hy | Rejection reference no: | | Material name | Tem code= Batch no JOC ref no. | Manufacturer name mnufaclurer batch no. ‘Guanhiy: Supplier name No. of container/carton/bag: Thvestigation: Root cause of rejection Proposed preventive action if any Report submified by Name & designation of the person \ ee (Signature & date) ih)REJECTION LABEL OPSONIN PHARMA LIMITED BARISHAL Manufacturer! Origin: Product/Material Name: Material Code: 2 5 g s 3 3 = Container/Box No.: Potency: Quantity: Exp. Date: Disposition Status: Managet QA’ Authanized Person Date Remarks: ‘Signature: