& LEOSTAR = A Promise for Health To, Date: 29.06.2023 ‘The Drug Control Administration, CDSCO Zonal Office, Hyderabad,CDSCO Bhavan, Beside T.B and Demonstration Center. Vengal Rao Nagar, Hyderabad, Telangana. Dear Sir, Subject: pplication for the grant of WHO GMP CERTIFICATE We M/s. LEOSTAR Healthcare Pvt.Lid.et Sy.No.321,PlotNo.10,BiotechPark, Phase-II1,Genom Valley, Karkapatla(V),Markook(M), Siddipet (D)- 502281, Telangana,India. We here by apply for WHO GMP CERTIFICATE to manufacturing for sale or distribution of drugs We request your good selves to Issue us the WHO GMP CERTIFICATE. at the carliest for the applied product ‘We have enclosed the below mentioned documents for your perusal. 1. Covering letter 2. Authorization Letter 3. List of applied Product 4 ist of SOP and STP 5. Stabi Data of Applied Product 6. 7. 8. Process Validation of the applied Product Product summary sheet . Manufacturing License Copy 9. List of technical Staff 10. Site Master Fite 11. Manufacture Layout 12, Water System Diagram and HVAC 13, List of Equipment and Instrument indly acknowledge our application and do the need fut Yours Faithfully For LEOSTAR Healtheare Pvt.Ltd Managing Director LEOSTAR Healthcare Pvt. Ltd. ‘Admin Address : Plot No.178, Eastern Part, First Floor, South Block, Street No.14, Suryanagar, Uppal, Hyderabad - 500039 Mig. Address: Plot No-10, Biotech Park, Phase-IIl, Genome Valley, Karkapatla (V), Markook(M}, Telangana - 502281 Ce eed& LEOSTAR’ = A Promise for Health Date: 05" July 2023 We Mis. LEOSTAR Healthcare Private Limited, a company/Firm incorporated under the Companies Act, 2013, having its principal place of business at 1 Floor, D.No.2-I- 49/2/178/Eastern, South Block,Suryanagar, Street No. 14, Uppal, Hyderabad- 500039, Telangana, Factory at. Plot No. 10, Biotech Park ,Phase Il], Karkapatla village, Dist. Siddipet. do hereby nominate, and authorize for and on behalf ourselves, Rajiv Reddy Challa , aged 49 Years, Managing Director. LEOSTAR Healthcare Pvt. Ltd., to do all work and execute the following acts and deeds for us on behalf of us in the matter hereinafter mentioned below: 1. To sign, apply, execute all documents in the office of CDSCO & DCA HYDERABAD Form LEOSTAR Healthcare Private For LEOS:AR Healthcare Pvt. Ltd. For: LEOSTAR Healthcare Pvt. Led. OX tr tote Rajiv Reddy Chaha"49'"9 Director Malathi Challa Managing Director Director LEOSTAR Healthcare Pvt. Ltd. ‘Admin Address : Plot No.178, Eastern Part, Fist Floor, South Block, Street No.14, Suryanager, Uppal, Hyderabad - 500039 Mfg. Address: Plot No-10, Biotech Park, Phase-II, Genome Valley, Karkapatla (V), MarkooK{M), Telangana - 502281 Se espe eee(®LEOSTAR Date: 05/07/2023 MANUFACTURER ADDRESS DECLARATION We Leostar Healthcare Private Limited hereby declare that the manufacturing of Paracetamol Paediatric Oral Suspension IP 125mg is being manufacturing at our site located Sy No. 321, Plot No. 10, Biotech Park, Phase-III, Genome Valley, Karkapatla(V), Markook(M), Siddipet (Dist)-502281, Telangana State, India. Authorized Signatory For Leostar Healthcare Private Limited LEOSTAR Healthcare Pvt. Ltd. ‘Admin Address : Plot No.178, Eastern Part, First Floor, South Block, Street No.14, Suryanagar, Uppal, Hyderabad - 500039 Plot No-10, Biotech Park, Phase-Ii, Genome Valley, Karkapatla {V), Markook(M), Telangana - 502281 © [email protected](@LEOSTAR LEOSTAR A Promise for Health Date: 05/07/2023 LIST OF PRODUCT APPLYING FOR ISSUANCE OF COPPs (WHO- P) We Leostar Healthcare Private Limited hereby informing that the following product is applying for issuance of COPPs (WHO-GMP). S.No. ‘Name of the Product or Paracetamol Paediatric Oral Suspension 125mg IP For Leostar Healthcare Private Limited LEOSTAR Healthcare Pvt. Ltd. © Bitin Asses: Plot No.a7e, Eater Part, Fra Floor, South lock, Steet No.4, Suryanagar, Uppal, Hyderabad - 500039 Plot No-10, Biotech Park, Phase-Ill, Genome Valley, Karkapatla (V), Markook(M), Telangana - 502281MASTER CORY Quzostag LEO STAR HEALTH CARE PVT.LTD TITLE QUALITY ASSURANCE SOP INDEX [S.No.| SOBNo. Bileetive Date in| «Revie Date’ | Preparation, Approval, Control and Revision O1. | QA001-00 | oF Standard Operating Procedures, 09/08/21 08/08/23, 02. | QA002-00 | Training of Plant Personnel. 09/08/21 08/08/23 03. | QA003-00 | Format Issuance and Control. 09/08/21 08/08/23, 04. | QA004-00 | Equipment Numbering. 09/08/21 08/08/23, Guidelines for Qualification of Instruments, 05. | QA005-00 | Souipments and Utilities. 09/08/21 08/08/23 06. | QA006-00 | Authorized Signatories. 09/08/21 08/08/23 07. | QA007-00 | Document Control. 09/08/21 08/08/23 BEI Tssuance, Control & Retrieval of Analytical 08. | QA008-00 | rest Data Sheets. 09/08/21 08/08/23 (09. | QA009-00 | Preparation, Issuance & Control of BMR/BPR.| 09/08/21 08/08/23, Batch Manufacturing Record & Batch Packing 10. | QA010-00 | Record Review and Release for Dispatch, 09/08/21 osi08/23 11. | Qa011-00 | Good Documentation Procedure. 09/08/21 08/08/23, Procedure for Sampling of In-Process, Semi 12. | QA012-00 | Fer ad Finished Product, 09/08/21 08/08/23, 13. | QA013-00 | Line Clearance, 09/08/21 08/08/23 14, | QA014-00 | Good Manufacture Practices, 09/08/21 08/08/23 15. | QA015-01 | Calibration of Balances. 06/09/22 0s/09/24 16. | QA016-00 | Hygiene Policy. 09/08/21 08/08/23, 17. | QA017-00 | SOP for Process Validation. 09/08/21 08/08/23, 18 | Qao1s-00 | Safety and First Aid 09/08/21 08/08/23 19. | QA019-00 | Change Control. 09/08/21 08/08/23 20. | QA020-00 | Incidents and Deviation. 09/08/21 08/08/23 21. | QA021-00 | In-Process Checks. 11/08/21 10/08/23 SOP for Regular Validation of Equipment’s 22, | @A022-00 | aoa utes 11/08/21 10/08/23 23. | QA023-01 | Job Responsibilities. 11/08/21 10/08/23 PREPARED BY ‘CHECKED BY AIG BY SIGN AND DATE > ao” PBprwt> 4) oo} oi} ona NAME & R.BHARGAVI ‘CH.ABHILASH G.RAJESH DESIGNATION EXECUTIVE -QA EXECUTIVE -QA MANAGER - QA Page {ofSMASTER CORY Qo LzosTag LEO STAR HEALTH CARE PVT.LTD TITLE | QUALITY ASSURANCE SOP INDEX '8.No.| SOP.No. Title. |_ Bfigetive Date, .| Review Date: 24. | QA024-00 | Medical Examination for Plant Personnel. 11/08/21 10/08/23 25. | QA025-00 | Handling of Rejected Material. 11/08/21 10/08/23 26. | QA026-00 | Non Conformance Material Investigation. 11/08/21 10/08/23 27. | QA027-00 | Handling of Market Complaints. 11/08/21 10/08/23 28. | QA028-00 | Disinfectant Usage Policy. 11/08/21 10/08/23 29 | A029-00 | Corrective and Preventive Action 11/08/21 10/08/23 30. | QA030-00 | Site Master File. 11/08/21 10/08/23 31. | QA031-00 | Validation Master Plan. 11/08/21 10/08/23 32 | QA032-00 | Calibration of Pressure Gauges. 1108/21 10/08/23 33. | QA033-00 | Product Recall. 1108/21 10/08/23 34. | QA034-00 | Handling of Returned Goods. Lvos2 10/08/23 35. QA035-00 Self Inspection Programme. 11/08/21 10/08/23 36. | QA036-00 | Finished Product Release. 11/08/21 10/08/23 37. | QA037-00 | Document Storage. 11/08/21 10/08/23 38. | QA038-00 | Reprocess and Rework. 11/08/21 10/08/23 39. | QA039-00 | Inspection of Transport Vehicles. 11/08/21 10/08/23 40. | QA040-00 | To Make Correction in Records. 11/08/21 10/08/23 ai. | Qao4i-00 Saat ond Deseton Cone 12/08/21 11/08/23, 42, | QA022.00 | Ce a role ee ee 12/08/21 1108723 43. | QA043-00 | Procedure for Stereo Indent and Issuance. 1208/21 11/08/23 44, | QA044-00 | Preventive Maintenance. 12/08/21 11/08/23 45. | QA045-00 | Risk Assessment of Processes/Activity. 12/08/21 11/08/23 46. | QA046-00 | Vendor Qualification. 12/08/21 11/08/23 PREP. ‘D BY iD BY APPROVED BY SIGN AND DATE Dea ele Be de eaoiloars NAME & RBHARGAVI CH.ABHILASH TGRAJESH DESIGNATION EXECUTIVE -QA EXECUTIVE -QA MANAGER - QA Page 2 0f3MASTER GOPY LEOSTAR LEO STAR HEALTH CARE PVT.LTD TITLE. QUALITY ASSURANCE SOP INDEX [SNe] SOP No. ‘ile RifectiveRate | Relea 47. | qaoa7-oo | Procurement, Receipt Inspection and Issue of | > 9g/>, 11/0823 48, | QA048-00 | Preparation & Approval of MFR. 12/08/21 1108723 49. | QA049-00 | Calibration of Thermometer 12/08/21 11/08/03 50. | QA050-02 | Batch Numbering System. 01/01/23 31/12/24 51, | QA0S1-00 | Annual Product Review 12/08/21 11/08/23 52. | QA052-00 | Compressor Air Quality Test. 12/0821 11/08/23 53. | QA053-00 | Preparation of Usage Log Sheets. 12/08/21 11/08/23 54 | QA0S4-00 | Contract laboratory evaluation & certification | 12/08/21 11708723, 55. | QA0SS-00 | Material Codes list 12/08/21 11/0823 56 | QA056-00 | Product change over 01/01/23 31/12/24 END OF THE DOCUMENT PREP, iD BY CHECKED BY APPROVED BY won | EE ee NAME & R.BHARGAVI CH.ABHILASH ~ GRAJESH DESIGNATION EXECUTIVE -QA EXECUTIVE -QA MANAGER ~ QA Page 3 ofMASTER COPY a LEOSTAR HEALTHCARE PVT.LTD TITLE __| QUALITY CONTROL SOP INDEX S.No.| SOP No. | ~ “"Fitle EffectiveBate. | Rewer Date. | Entry and Exit procedure in io Quality Control Ol. | QC001-00 Department 04/09/2021 03/09/2023 02. | Qc002-00 | Area Cleaning in Quality Control Laboratory | 04/09/2021 03/09/2023 Receipt, Handling and Cleaning of Glassware 03. | QC003-00 | 2a Sampling Toels ; 04/09/2021 03/09/2023 andling of sorap and spillage in Quality 04. | co0s-00 eee Lebaron? 7 4/09/2021 03/09/2023 Receipt, Storage and Use Of Laboratory 05. | QC00S-00 | Chemicals, Reagents and Primary Standards oasagv2021 03/09/2023 06. | QC006-00 | Handling of Hazardous and toxic chemicals 04/09/2021 03/09/2023 07. | 9C007-00 | Good Laboratory Practices 04/09/2021 03/09/2023 08. | QC008-00 | Analytical Chemist Qualification 04/09/2021 03/09/2023 09. | QC009-00 | Lab Safety Practices | 05/09/2021 04/09/2023 Preparation OF Indicator, Reagents, 10. | QC010-00 | Volumetric Solutions and Standardization of | 05/09/2021 04/09/2023 Volumetric Solutions “Temperature & Rh Monitoring In Quality U1. | gcor-o1 | Comper oe o1/i1/2022 30/10/2024 12. | Qc012-00 | Contract Laboratory Evaluation and 05/09/2021 04/09/2023 Certification 13. | QC013-00 | Rounding Off Analytical Results 05/09/2021 04/09/2023 Ta. | qcoia-oo | Operation And Calibration OF Analytical Renan Rees Balance 15. | QCO15-00 | Pharmacopoeial Compliance 05/09/2021 04/09/2023 Tob Responsibilities of Quality Control 16. | Qc016-00 | Devartment 05/09/2021 04/09/2023 v7. | @coi7-00 Blewoil Data Backup For Quality Control ses Guess T Preparation and Handling Of Working 18 | QC018-00 | standards and Handling Of Reference 05/09/2021 04/09/2023 | standards PREPARED BY CHE! D BY APPROVED BY SIGN AND DATE . H Bx siloilsoes Gerotions Hy orlnova NAME & G.Bhanusri KRamesh fajesh DESIGNATION Chemist -QC Asst. Manager -QC Page 1 of 4MASTER COPY LEOSTAR HEALTHCARE PVT.LTD TITLE — [QUALITY CONTROL SOP INDEX Sra} s0PNe | Fite Beteahedate | Riau | Sampling, Testing & Release Of Raw 19. | QC019-00 | materiale 05/09/2021 04/09/2023, 20. | QC020-00 | Retesting Of Materials | 05/09/2021 04/09/2023 Sampling, Testing & Release OF Packaging 21. | QC021-00 | Material’ 06/09/2021 08/09/2023 Receipt and Testing Of In-process Samples 22. | QC022-01 | and Finished products 06/09/2021 05/09/2023 Handling Of Samples To be Sent Extemal 23. | QC023-01 | 1 sboratory 06/09/2021 05/09/2023 24, | QC024-00 | Calibration Of Qe Instruments | 06/09/2021 05/09/2023 Equipment /Tastrument Usage Record In 25. | 6025-01 | gualty control department 06/09/2021 05/09/2023 Destruction Of Analyzed Samples In Quality 26. | QC026-00 | control department 06/09/2021 05/09/2023, Issue and Control Of Approved Labels and 27. | QC027-00 | Rejected Labels 06/09/2021 05/09/2023 28. | QC028-00 | Analytical Reference Numbering System 06/09/2021 05/09/2023 29. | Qc029-00 | Handling Of External Samples 06/09/2021 05/09/2023, | Preparation of Specification, Standard testing 30. | QC030-01 | procedure, Standard laboratory technique and 29/11/2022 28/11/2024 | analytical test data sheet Procedure For Review Of Analytical 31. | QC031-00 | Hocuments 06/09/2021 08/09/2023 ‘Compliance and Issuance of Cerificate of 32. | QC032-00 | aratysis 06/09/2021 05/09/2023 33. | QC033-00 | Handling Of Out Of Trend Results 06/09/2021 05/09/2023 34. | QC034-00 | Procedure for pipetting procedure 06/09/2021 05/09/2023 Identification and Documentation Of Incident 35. | QC035-00 | Gecurred During Quality control analysis 06/09/2021 05/09/2023 36. | QC036-00 | Out Of Specification 06/09/2021 05/09/2023 PREPARED BY CHE! BY Pde BY SIGN AND DATE i Gx tloilecg Ror | ov ee te pers NAME & G.Bhanusri K.Ramesh -Rajesh DESIGNATION Chemist -QC Asst. Manager -QC Manages QA Page 2of 4MASTER COPY FMLEOSTAR LEOSTAR HEALTHCARE PVT.LTD TITLE | QUALITY CONTROL SOP INDEX '8.No.| SOP No, ~Pitle Effective Bate Review Date) 37. | QC037-00 | Bracketing Standard In HPLC Analysis 06/09/2021 8/09/2023 38. | Qc038-00 | Mobile Phase Preparation 06/09/2021 05/09/2023 39. | cose.oo | Reset Handling, Performance, Washing OF [~~ oot See Columns is 40. | QC040-00 | Generation Chromatographic Report 6/09/2021 0s/09/2023, 41. | QC041-00 | Swab Testing For Approval Of Equipment 07/09/2021 06/09/2023 Operation And Maintenance Of Ultra 42. | 9042.00 | SFnicator Apparatus 07/09/2021 06/09/2023 43. | QC043-00 | Operation And Calibration Of Muffle Fumace | 07/09/2021 06/09/2023, 24. | qcoas.on | OPeation And Caleation Operation Hot AT | Sap pay sansati Operation & Calibration Of Friability 45. | Qc045-00 | Soaratus aud __|_omosra0a1 06/09/2023 46. | 046-00 | Procedure For Raw Water And Purified Water | 07/09/2021 06/09/2023 47. | QC047-00 | Laboratory safety practices 07/09/2021 06/09/2023, 48. | QC048-00 | Usage And Verification Of Calculators 07/09/2021 06/09/2023 49. | QC049.00 | Procedure For Operation Of Magnetic Stirer 7/09/2021 06/09/2023 50. | QC050-00 | Operation procedure for Water Bath 07/09/2021 06/09/2023 Operation And Calibration OF a 51. | QC051-00 | rhsiconductivity Meter 07/09/2021 06/09/2023, 52. | QC052-00 | Operation and Calibration Of pH Meter 07/09/2021 06/09/2023, | 53. | QC0S3-00 | Operation & Calibration Of Uv Chamber 07/09/2021 06/09/2023, sa. | ense.og | OPeaton& Calbation OF Disintegration cae eee 55. | QC055-00 ay ta 07/09/2021 06/09/2023 PREPARED BY CHECKED BY APPROVED BY SIGN AND DATE . A Cue lone Bann | Ory orto NAME & GBhanusri K-Ramesh Rajesh DESIGNATION. Chemist -QC Asst. Manager -QC Manager —- QA Page 3 of 4MASTER COPY iB LEOSTAR LEOSTAR HEALTHCARE PVT.LTD TITLE __| QUALITY CONTROL SOP INDEX 'S.No.| SOP No. _.. Title t Revew Rite, 56. | QC0S6-00 | Calibration Of Dissolution Test apparatus 07/09/2021 06/09/2023 57. | 9C057-00 | Operation OF Dissolution Test Apparatus 07/09/2021 06/09/2023 58. | acosa-oo | Operation and Calibration OF Stability 07/09/2021 06/09/2023 59. | QC059-00 | Monitoring Of Stability Chambers 07/09/2021 06/09/2023 60. | QC060-00 | Stability Study(Drug Product) 07/09/2021 06/09/2023 61. | QC061-00 | Maintenance Of Desiccator 07/09/2021 06/09/2023 62. | Qco62-00 eae and Calibration Of Karl fischer | 7799/2021 06/09/2023 63. | qcoes-oo | brocade For Sea: Destribution | 7/09/2021 06/09/2023, 64. | QC064-01 ieee ty ale | 01/01/2023 31/12/2025 65. | QC065-00 icine tepainyerd eine 21/07/2022 20/07/2024 bse Teens Open so ae of PLE as aes 67 | Qc067-00 fame ce eae 02/08/2022 01/08/2024 68 | Qc068-00 Paees esac oftpH meter - 15/08/2022 14/08/2024 $51(| c0eea0 | genet CHa cance 15/08/2022 14/08/2024 7 ry Operation Verioaton of moisture analyser-| 5 9g/9q99 spines 71 | Qear-an | Opselen& Calireton of Taber Hares 15/08/2020 ae END OF THE DOCUMENT PREPARED BY CHECKED BY APPROVED BY SIGN AND DATE Gy ete SONIA? ees, bor}rone ‘NAME & G.Bhanusri ‘KRamesh ‘GRajesh DESIGNATION Chemist -QC Asst. Manager -QC Manager- QA Page 4 of 4MASTER Copy, (a LEOSTAR LEOSTAR HEALTH CARE PVT.LTD THLE ENGINEERING SOP INDEX S.NO SOP NO. Title Effective Date | Review Date 01 | EU001-00 _ | Operation of Air Handling Unit 21/08/21 20/08/23 o2 | Eu002-00 | Preventive Maintenance of Air Handling 21/08/21 20/08/23 03 | BU003-00 | Preventive Maintenance of Air Compressor | 21/08/21 20/08/23 (04_| 2004-00 __| Operation Procedure for Chiller 21/08/21 20/08/23 ‘Operation of Puritied Water Generation and 05 | E0000 | enti Suto 06/09/22 osvosi4 06 | EU006-00 ae ieieereeteebiacnasarra 21/08/21 20/08/23 Preventive Maintenance Procedure for 07 EU007-00 Cooling Tower 21/08/21 20/08/23 Preventive Maintenance of Stability 08 EU008-00 Chamber 21/08/21 20/08/23 09 EU009-00 Operation Procedure of Boiler 21/08/21 20/08/23 10 EU010-00 Preventive Maintenance of Boiler 21/08/21 20/08/23 ‘Cleaning and Sanitization of Storage Tanks, RO Wu EU011-01 System, EDI and Purified Water Distribution 06/09/22 05/09/24 System 12, EU012-00 Preventive Maintenance of Sampling Booth 21/08/21 20/08/23 13 | BU013-00 en Maintenance of Dispensing 21/08/21 20/08/23, 14 | Euor400 _| Preventive Maintenance of Dynamic Pass 2108/21 20/08/23 15 EU015-00 Preventive Maintenance of Static Pass Box 21/08/21 20/08/23 16 | EU016-00 | Preventive Maintenance of Fume Food 208/21 20/08/23 17 EU017-00 Preventive Maintenance of Hot Air Oven 21/08/21 20/08/23 Preventive Maintenance of Ceiling 18 EU018-00 Suspended Laminar Air Flow 21/08/21 20/08/23 19 | Bu019-00 reve Maintenance of De-dusting 21/08/21 20/08/23 20_| EU020-00__ | Procedure for Passivation of SS Equipment | 21/08/21 20/08/23 21 EU021-01 Preventive Maintenance Programme 01/01/23 31/12/25 PREPARED BY CHECKED BY APPROVED BY a is . sien AND pate | ZAg olor | BER Hed —onlyg Yor 207 NAME & B.VENKATESH VNAGARAJU GRAJESH DESIGNATION, EXECUTIVE -EU_| ASST.MANAGER - EU MANAGER - QA. Page 1 of 3SMASTER COPY LEQSTAR LEOSTAR HEALTH CARE PVT.LTD TILE ENGINEERING SOP INDEX SNO| _SOPNO. Title Effective Date | Review Date 22 | wu0z2-o0 | Btvetve Maintenance of Power Cont | ong 221083 23_| E0023-00 _ | Calibration Programme 23/08/21 2210873 Raw Water Managemeni(Received In 24 | EU024-00 | Tankers) and Cleaning of Raw Water 23/08/21 22/08/23 Storage Tanks 25_| BU025-00__| Break Down Maintenance 07/09/22 06/09/24 26 | Evor6.0 | Preventive Maintenance of Sugar Melting] Gr;99y99 6/09/24 27 | B027-00 Same Maintenance of Syrup 07/09/22 06/09/24 reparation Vessel 28 | BU028-00 _ | Preventive Maintenance of Storage Vessel _| 07/09/22 06/0974 29 | BU029-00 _| Preventive Maintenance of Colloid Mill 07/09/22 06/09/24 30_| BU030-00 _| Preventive Maintenance of Transfer Pump | 08/09/22 07/09/24 Preventive Maintenance of Rotary Bottle 31_| Bu031-00 | Washing Eaupment f 08/09/22 o7sig 32_| _5U32-00 __| Preventive Maintenance of Tum Table 08/09/22 07/09/24 33__|__EU033-00__ | Preventive Maintenance of Filter Press 09/09/22, 07/09/24 34 | 0034-00 _ | Preventive Maintenance of Transformer 08/09/22 07/09/24 Preventive Maintenance for Liquid Bottle 35 | _£U035-00 | Filling & Head Rope Cap Sealing Machine Oe onan 36 | BU036.00 | Preventive Matpienance for Online Botle 09/09/22 08/09/24 B74 U3 7, 00-He | renee peteereeetn tot tuner ona) oagayoya 08/09/24 38 | BU038-00 | Preventive Maintenance of Blister Packing 10/09/22 09/09/24 39 | BU039-00 | Preventive Maintenance of De-Foiling 10/09/22 09/09/24 Preventive Maintenance of Automatie Capsule 40 | Euo400 | Fie Mecme 10/09/22 09/09/24 41 | Buo41.00 | Preventive Maintenance of Dosing Cup 10/09/22 09/09/24 42_| 1004-00 _ | Preventive Maintenance for Metal Detector | 12/0922 11709724 43 | _U043-00__| Preventive Maintenance of Dust Collector | 12/09/22 11/09/24 PREPARED BY CHECKED BY ‘APPROVED BY IGN AND DATI NT] , si B] Barolo | SSA acas ep oes NAME & B.VENKATESH VNAGARAJU GRAJESH DESIGNATION | EXECUTIVE-EU_| ASST.MANAGER-EU | _MANAGER-QA Page 2 of 3MASTER COPY LEOSTAR LEOSTAR HEALTH CARE PVT.LTD efor cth TITLE ENGINEERING SOP INDEX S.NO SOP NO. Title Effective Date | Review Date Preventive Maintenance of Double Rotary 44 | Buode.oo | Prevenive Mainienan 1210922 11/09/24 45 EU045-00 Preventive Maintenance of Auto Coater 12/09/22 11/09/24 46 FU046-00 ae Maintenance of Product Storage 13/09/22 12/09/24 Preventive Maintenance of Rapid Mixer 47 | Bu047-00 pel 13/09/22 12/09/24 48 | BU048.00 Boel icraaseceeeeeieumcueeee 13/09/22 120924 49 EU049-00 Preventive Maintenance for Multi Mill 13/09/22 12/09/24 30_| BU050-00 _ | Preventive Maintenance for Vibro Sifter 14/09/22 13/0974 Preventive Maintenance of Paste Ss. EU051-00 Preparation Vessel 14/09/22 13/09/24 32 | BU052-00 _ | Preventive Maintenance of De-duster 14709723 130974 53 | Bu0s3-00 | Preventive Maintenance of Stip Packing | 1 gog/o2 13/09/24 54. EU054-00 Preventive Maintenance of Octagonal 15/09/22 14/09/24 Blender 55 | FU055-00 | preventive Maintenance of Planetary Mixer | 15/09/22 1409124 56 | BU0s6.00 | Preventive Maintenance of Wax Melting 15/0922 14/0924 57 EU057-00 Preventive Maintenance of Vacuum Pump 16/09/22 15/09/24 Preventive Maintenance of Linear Tube. 58 | Eu0se-00 | Pre ean 16/09/22 15/09/24 59 EU059-00 Preventive Maintenance of Air Curtains 16/09/22 15/09/24 60 EU060-00 Preventive Maintenance of Insect Killer 17/09/22 17/09/24 END OF TRE DOCUME! PREPARED BY CHECKED BY APPROVED BY : 4 SIGN AND DATE Hae oon we ladasns, ets osfrord NAME & B.VENKATESH V.NAGARAJU G.RAJESH DESIGNATION, EXECUTIVE - EU ASST.MANAGER -EU MANAGER - QA Page 3 of 3MASTER COPY LEO STAR HEALTH CARE PVT.LTD ‘TITLE "WARE HOUSE SOP INDEX 01. | WHO01-00 Opening And Closing Procedure Of Ware 09/08/21 08/08/23, 02. | WH002-00 | Sanitation and Cleaning Of Ware House 09/08/21 08/08/23 Receipt, Storage And Approval / Rejection Of 03, | WH003-01 | Rew And Packaging Material “92/01/23 01/01/25 04. | wHo04-00 Eprerra Storage And Issuance Of Product 09/08/21 08/08/23 05. | WHO05-00 | Status Labeling 09/08/21 08/08/23 Procedure For Receipt, Issue And Control Of 06. | WH006-00 ‘Quarantine Labels 09/08/21 08/08/23 Entry, Exit And Gowning Procedure For 07. | WHO07-00 | Serpling Room 09/08/21 08/08/23 08. | WH008-01 | Operation Procedure For Sampling Booth 16/09/22 15/09/24 Entry, Exit And Gowning Procedure For 09. | WH009-00 Dispensing Area 09/08/21 08/08/23 10. | WHO10-00 | Cleaning Of Weighing Balance 09/08/21 08/08/23 11. | WHO11-00 | Operation Of Weighing Balance 09/08/21 08/08/23 12. | WHO12-00 | Cleaning Procedure For Standard Weights 09/08/21 08/08/23 Procedure For Transfer Of Raw Material And 13. | WHO13-00 | Packing Materials From Central Ware House 09/08/21 08/08/23 To Respective Manufacturing Locations Cleaning Of Raw Material Sampling And 14. | WHO14-01 Dispensing Booth 15/09/22 14/09/24 Dispensing And Issuing Of Primary And 15, | WHO15-00 Secondary Packaging Material 09/08/21 08/08/23 16. | WHO16-00 | Operating Procedure For Dispensing Booth 10/08/21 09/08/23 Dispensing And Issuance Of Raw Materials 17. | wHo17-00 | pSpenne 10/08/21 09/08/23 Se Procedure For Dispensing And Issuing OF 18 | WHO18-00 |r iquid Chemicals To Production esha bidhde 19. | WHO19-00 | Cleaning And Storage Of Dispensing Tools 10/08/21 09/08/23 Handling And Control Of Loose Container OF 20. | WHO020-00 ‘Raw Material 10/08/21 09/08/23 Storage And Preservation OF Raw, Packaging 21. | WHO21-00 Material And Finished Goods 10/08/21 09/08/23 PREPARED BY CHECKED BY APPROVED BY SIGN AND DATE prods Meant enviar NAME & ones Gon T.MAHESH G.RAJESH DESIGNATION EXECUTIVE -WH MANAGER - QA. Page tof?MASTERCOPY Quzostag LEO STAR HEALTH CARE PVT.LTD TITLE __| WARE HOUSE SOP INDEX SNo.| SOPNo [= a Bile : Procedure for Re-Sealing and Re-Packing Of 22. | WHO22-00| Conninere / Packs 10/08/21 09/08/23 Repacking Of Damaged Container During The 23. | WHO23-00 | Handling 10/08/21 09/08/23 24. | wH1024-00 | Procedure For Re-Test Of Material 10/08/21 09/08/23 25. | WH025-00 | Operation And Cleaning Of Trolly 10/08/21 09/08/23 26. | WH026-00 | Cleaning of HDPE Pallets 10/08/21 09/08/23 27, | wei027-00 | Receipt: Storege And Dispatch OF Finished 10/08/21 09/08/23 Procedure For Action Plan Deviation From 28. | WH028-00 | Srecified Environmental Limit 10/08/21 09/08/23 Procedure For Excess Material Receipt From 29. | WH029-00 | Production Department 10/08/21 09/08/23 30. | wH030-00 | Disposal Of Obsolete Materials 10/08/21 09/08/23 31, | wH031-00 | Procedure For Inventory Verification 10/08/21 09/08/23 32 | wH032-00 | Handling And Storage Of Hazardous Material 10/08/21 09/08/23 END OF THE DOCUMENT PREPARED BY CHECKED BY ‘APPROVED BY eee Borgata At eiuhs SGAoiloor3 NAMES ‘T.BHAVANI TMAHESH GRATES DESIGNATION EXECUTIVE-wa__|_EXECUTIVE-wH MANAGER - QA Page 2 0f2LEO STAR HEALTH CARE PVT.LTD TITLE | PRODUCTION SOF INDEX SING |S8t 2h Sean : La |. Bikerve Date. Js Raia, ot. | ppoor.o9 | EREY and sit posed into production 9/09/21 08/0923 02. | PD002-00 | Gowning procedure, 09/09/21 08/09/23 03. | PD003-00 | Good manufacturing practices. 09/09/21 08/0923 Functions and Responsibilities of Production 04 | PD004-00 | Devartment 09/09/21 08/09/23 05. | PDO0S-01 | Equipment Usage Log. 02/01/23 o/oL/2s ‘Monitoring of Temperature and Relative 6. } PD006-00 | Nmidiry 09/09/21 08/09/23 07. | PDO007-00 | Status labeling. 09/09/21 08/09/23, T Preparation of 1 % Sodium Lanryl Sulphate de 08. ) PD008-00 | Tose Isopropyl Alcohol Solution, osrovrt owas 09. | PD009-00 | Eliminating Cross Contamination. Hl 09/09/21 08/09/23 10. | pD010-00 | Cleaning of Miscellaneous Items. 9/09/24 8/09/23 ‘Monitoring of Differential pressure in 11, | PDOLL-00 | Merfacturing area, 09/09/21 08/09/23 12. | PD012-00 | Operation and cleaning of Vibro Sifter. 10/09/21 09/0923 13. | PDO13-00 eee cleaning of Paste Preparation | yo/o9/1 09/09/23 14. | PDO14-00 | Operation and cleaning of Octagonal Blender 1010921 09/0923 Operation and cleaning of Rapid mixer 15. | PDO1S-00 Granulator. 10/09/21 09/09/23 16. | PD016-00 paatts and cleaning of Fluidized Bed 10/09/21 09/09/23 17. | PD017-00 | Operation and cleaning of Multi Mill. 10/09/21 09/09/23 18 | PDO18-00 | Operation and cleaning of Auto Coster 10/09/21 09/09/23 ‘Operation And Cleaning Of Compression 19, | PDO19-00 | YPehine 27 Station 10/09/21 09/09/23 Operation And Cleaning Of Capsule Filing 20. | PD020-00 | Vfachine. 1009721 09/09/23 21. | PD021-00 | In-Process Checks During Capsule filling 11/09/21 ~ 009/23 PREPARED BY ‘CHECKED BY_ APPROVED BY_ IGN \TE a oe ae MSL slalas Morlolees | —tdeceper ha NAME & 'M.SAI KUMAR K.NAGENDRA BABU G.RAJESH DESIGNATION EXECUTIVE -PD MANAGER -PD. MANAGER - QA Page 1of2MASTER CORY LEO STAR HEALTH CARE PVT.LTD TITLE | PRODUCTION SOP INDEX NGS ie eee Titedvepae | Retemate | 22. | PD022-00 | in-Process Checks during Tablet production. 11/09/21 10/09/23 ‘Operation And Cleaning of Alu-Alu Blister 23. | PD023-00 | eaoking Machine, 11/09/21 10/09/23 Operation And Cleaning of Strip packing 24, ) PDO24-00 | Machine. Ly/og/21 10/09/23, 2, | PD025-00 | Visual inspection of tablets. 11/09/21 10/09/23 26. | PD026-00 | House Keeping In Manufacturing Area. 11/09/21 10/09/23 ‘Operation And Cleaning of Solution 21. | PD027-00 | preparation Vessel. 109721 10/09/23 28. | PD028-00 | Operation And Cleaning of Pass Boxes. 110921 10/09/23 29 | pD029-00 | Operation And Cleaning of Metal Detector 10921 10/09/23, 30. | PD030-00 | Operation And Cleaning of Dust collector. 11/09/21 10/09/23 31. | PDO31-00 | Operation and Cleaning of Colloid Mill. 12/09/21 11/09/23 \ 32 | Ppox2-oo | Operation and Cleaning of Sugar as 12/09/21 1109723, Operation and Cleaning of Zero Hold Up 33. | PD033-00 Filter press. 12/09/21 11/09/23 34, | PDO34-00 | Operation of Bottle Washing Machine 12/09/21 11/09/23 | ‘Operation and Cleaning of Automatic Liquid 35. | PDO3S-00 | Flting Line i 12/09/21 11/09/23 36. | PD036-00 | Operation and Cleaning of Wax Melting 12/09/21 11/09/23 37. | PR037-00 | Operation and Cleaning of Planetary Mixer 12/09/21 11/09/23 Operation and Cleaning of Ointment Tube 38. | PDO38-00 | Fitting Machine 1209721 11/09/23 Procedure for Fumigation in production area 39. | PD039-00 | ican rooms). 12/09/21 11/09/23 END OF THE DOCUMENT PREPARED BY CHECKED BY APPROVED BY SIGN AND DATE 1 Ssh lols Nb lola] es pe pes NAME & M.SAI KUMAR K-NAGENDRA BABU G.RAJESH DESIGNATION. EXECUTIVE -PD MANAGER -PD MANAGER~QA_ Page 2 0f2WAVE ww LEO STAR HEALTH CARE PVT.LTD LEOSTAR Benen STANDARD TESTING PROCEDURE INDEX TITLE ‘Name of the product: Paracetamol Paediatric Oral Suspension 125mg IP In-Process: S.No. | Type of the sample I STP No. EffectiveDate | Remarks | Paracetamol Pediatric Oral 01. Suspension IP-125 mg Bulk | LL/STP/IPFE1/1H/01-01 20-03-2023 cai |___ sample Finished: Ht (S.No. | Type of the sample t STP No. EffectiveDate | “Remarks aracetamol Pediatric Oral 01. Suspension IP-125 mg Finished LL/STP/FPFEL/IP/01-01 20-03-2023 - ple END OF THE DOCUMENT PREPARED BY CHEC] BY APPROVED. BY aro | — Oe %olea|0r? SIGN AND DATE Csshor hu NAME & R.MAHESH K. RAMESH ‘GRAIESH DESIGNATION EXECUTIVE-QC_| Asst. 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This protocol cannot be executed until signed and approved by following personnel Department Name Designation Signature (Date PREPARED BY te QUALITY ASSURANCE | RBHARGAVI EXECUTIVE PRODUCTION MSAIKUMAR EXECUTIVE REVIEWED BY M.SHASHIDHAR PRODUCTION prea S.V.SUBBA RAO QUALITY CONTROL BA Shu QUALITY ASSURANCE | CH.ABHILASH EXECUTIVE eb gor See APPROVED BY yy QUALITY ASSURANCE | G.RAJESH MANAGER Aue LS/QA017/F01-00MASTE ALiosTAR : | LEO STAR HEALTH CARE PRIVATE LIMITED PROCESS VALIDATION PROTOCOL Product Name FEPANIL 125 MG Generic Name PARACETAMOL PAEDIATRIC ORAL SUSPENSION Protocol Number a [revscetioner Pe] | reve | [veri | 1.0 PREAMBLE: The Manufacturing process of “Paracetamol Paediatric oral suspension” is proposed to validate concurrently at Leostar Healthcare Pvt. Ltd, Production Liquid Line by using an Active Pharmaceutical Ingredient (APT) Paracetamol, The Paracetamol is being procured from the ‘Manufacturer (vendor) “SRIKRISHNA PHARMA”. 2.0 OBJECTIVE: Objective of this protocol is to validate and establish the documented evidence providing high degree of assurance that the manufacturing process will consistently deliver the Paracetamol paediatric oral suspension using an API, Paracetamol procured from the vendor “SRIKRISHNA PHARMA” and shall meet the predetermined specifications and quality attributes /characteristics to verify the stability, and reproducibility of the product. 3.0 SCOPE: The scope of this protocol covers prospective process validation of three batches of Paracetamol Pediatric oral suspension manufactured at M/s. LEOSTAR HEALTHCARE PRIVATE LIMITED. 4.0 RESPONSIBILITIES: This protocol is a joint responsibility of the following: > Production: © Manufacturing of product as per BMR and BPR. ‘+ Preparation and review of process performance qualification protocol. ‘© Execute the process validation by following the manufacturing instructions as per batch manufacturing record and approved protocol. © Ensure that all process parameters are to be followed as per Batch manufacturing Record and respective SOPs. = Co-ordinate with QC while sampling and QA while Line clearance activity. © Record the details of devietion, equipment breakdowns, and changes and cut of specifications (00S) if any observed during manufacturing activity. > Maintenance: Support function for the manufacturing of product. Review of the validation Protocol with respect the content of maintenance department, Ensure that preventive maintenance is completed as per the schedule. Ensure all the equipment which are used in process validation is qualified and calibration state, © Ensure that all instruments such as pressure gauge, temperature indicator etc. are calibrated. «Record the deviations and breakdown, if any. LS/QA017/F01-00MASTER CO! LEO STAR HEALTH CARE PRIVATE LIMITED PROCESS VALIDATION PROTOCOL | ProductName | : | FEPANIL 125MG Generic Name PARACETAMOL PAEDIATRIC ORAL SUSPENSION PN a RevionNumber |; [00 | agen fs] sorts > Warehouse + Review of the process validation protocol Dispensing of raw materials upon request from production department. ‘+ Make sure that all raw materials are approved before issuing to the production department. © Check and confirm validity of Manufacturing and Expiry / Retest dates. « Follow FIFO / FEFO Procedure while issuing of raw materials to the production department. + Record the deviations if, any. > Quality Control + Review of process validation protocol. + Collect the samples as per the approved protocol and test as per the approved standard test procedure, * — Stability / Hold time studies to be initiated «Record the details of Out of specifications (00S) and Laboratory incidents, if any. > Quality Assurance Review of process validation protocol. Monitoring, Sampling, review and approve the validation activities, Coordinate for the preparation of process validation protocol. Overall co-ordination for validation activity including process execution, sampling ete. Monitor and verify the validation activities as per the approved protocol and make sure all the steps are followed as per the Batch Manufecturing record (BMR) and SOPs. Investigate, review, and approve the breakdown, deviations, incidents, changes, delays and out of specifications (00S) if, any. Approval of the process validation protocol. 5.0 PRE-REQUISITES OF THE VALIDATION ACTIVITIES: Identify the validation team and assign responsibilities for execution of the validation activities. Wherever required training to be imparted on process Validation protocol. ‘All major equipment, supporting accessories should be qualified for their intended use and all support accessories are in valid calibration status. Ensure all equipment having proper identification. Ensure that the operation, cleaning, calibration and preventive maintenance of all the equipment are performed as per their respective SOPs. LS/QA017/F01-00MASTER COPY LEO STAR HEALTH CARE PRIVATE LIMITED PROCESS VALIDATION PROTOCOL ProductName | : | FEPANIL 125MG Generic Name PARACETAMOL PAEDIATRIC ORAL SUSPENSION FoosiNonbe [7 [ASPVPLLREL —_[EtewneDve |] silnfeor | Revision Number ‘© Ensure all the operating persons are wearing appropriate personal protective equipment before entering into the manufacturing area and take necessary safety precautions while performing production operations. ‘+ Approved raw materials shall be used in the manufacturing of desired product. VALIDATION TEAM: S.No. Department Name Designation T._| Production M, Shashidhar Babu Manager 2,__| Production K, Nagendra Babu Manager 3._| Production M, Sai Kumar Executive 4,_| Quality Control SV. Subbarao Manager 3._ | Engineering & Utilities ViNageraju ‘Asst. Manager 6._ | Warehouse T. Bhavani Executive 7 | Quality Assurance ‘Ch.Abhilash Executive 8. | Quality Assurance GRajesh Manager 6.0 VALIDATION PROCEDURE: ‘The validation is a process describes the identification, monitoring and evaluation of factors thet direct! or indirectly affect the manufacturing and quality of a product. 6.1 BRIEF DESCRIPTION OF THE MANUFACTURING PROCESS: STEP I: BASE SYRUP PREPARATION: +e Take purified water in Sugar Melting Vessel fitted with stirrer. Raise the temperature with aid « steam jacket of tank to 80°e - 90"e. + Add gradually sucrose to the Sugar melting vessel with continuous stirring cool the syrup to 30°e 40°. STEP II: PREPARATION OF 20% STOCK SOLUTION: + Take purified water and gradually add sodium hydroxide with continuous stirring. Then allow it cor up to room temp. # Dissolve propyl paraben in above solution with continuous stirring for 10 min. © Take purified water and add sodium hydroxide with continuous stirring for 10 min. «Take purified water and add citric acid with continuous stirring for 10 min, ‘© Take purified water and add Bronopol with continuous stirring for 10 min. STEP IJ: SYRUP FILTRATION: ‘Filter the syrup through 100# nylon cloth to manufacturing tank check the clarity. LS/QA017/F01-00MASTER COPY | : | LEO STAR HEALTH CARE PRIVATE LIMITED PROCESS VALIDATION PROTOCOL Product Name : | FEPANIL 125 MG Generic Name PARACETAMOL PAEDIATRIC ORAL SUSPENSION STEP IV: ADDITION OF COLOUR ‘* Disperse and dissolve colour erythrosine supra in purified water and add to the manufacturing vesst with stirring through 100# nylon cloth. STEP V: PREPARATION OF PARACETAMOL SLURRY: «Pump glycerine and Sorbitol to the ss tank fitted with stirrer. * Add paracetamol to above tank with stirring for 15 min. pump purified water with stirring for 1 min, «Add Sugar syrup to paracetamol slurry with stirring. ‘+ Recirculate paracetamol slurry through colloid mill for 45 mins, STEP VI: PREPARATION OF CARBOPOL SLURRY ‘© Pump purified water with stirring for 15 min add Carbopo! to above tank with stirring for 15 min. ‘© Dissolve sodium hydroxide in water and add to the Carbopol dispersion with stisring to from thic gel. “s Add sugar syrup to Carbopol slurry with stirring STEP VI: PREPARATION OF XANTHAN GUM SLURRY: « Take purified water in SS, Tank then gradually add Xanthan gum with continuous stirring foe 1 min, «Then add Sorbitol to Xanthangum slurry with continuous stirring for 15 min, # Add sugar syrup to Xanthangum slurry with continuous sting. STEP VII: ADDITION OF CARBOPOL SLURRY, PARACETAMOL SLURRY & XANTHANGUM SLURRY: «Transfer the Carbopol slury to the syrup preparation tank with continuous stirring. «Transfer the Xanthan gum slurry to the manufacturing tank with continuous stirring. ‘© Transfer the paracetamol slurry to the Mfg. Tank. STEP IX: ADDITION OF ESSENCE: BANANA NO: 1 FLAVOUR: «Add banana No.1 flavour to manufacturing tank with continuous stirring. STEP X: COLLOIDING: ‘« Homogenize the manufacturing solution by passing through colloidal mill in to the storage tank for 40 min. «Makeup the final required volume with purified water and mix the solution for 30 min, + pH ADJUSTMENT: Check the pH (5.00 to 6.00) of the solution in manufacturing vessel (adju: the pH of the Solution to 5.0 to 6.0. If not adjust addition quantity of citric acid/sodium citrat whichever be applicable). LS/QA017/F01-00MASTER COPY LEO STAR HEALTH CARE PRIVATE LIMITED PROCESS VALIDATION PROTOCOL [rename [| [ceienene [| MusosTaR ed FEPANIL 125 MG PARACETAMOL PAEDIATRIC ORAL SUSPENSION |_ Protocol Number | : | LS/PVP/LLFEL Effective Date afer ‘|__ Be 62 PROCESS FLOW Ep DISPENSING SUGAR SYRUP PREPARATION STOCK SOLUTION PREPARATION ¥ ‘SUGAR SYRUP FILTRATION + ‘SUGAR SYRUP TRANFER TO THE SYRUP PREPARATION TANK t ADDITION OF COLOUR PREPARATION be PARACETAMOL SLURRY | PREPARATION OF CARBOPOL SLURRY PREPARATION OF XANTHAN GUM SLURRY. ADDITION OF CARBOPOL& PARACETAMOL & XANTHAN GUM SLURRY 1 ADDITION OF ESSENCE LS/QA017/F01-00MASTER COPY LEO STAR HEALTH CARE PRIVATE LIMITED PR OCESS VALIDATION PROTOCOL Product Name Generic Name Protocol Number Revision Number FEPANIL 125 MG PARACETAMOL PAEDIATRIC ORAL SUSPENSION tsrvrmure: — [eteeoae[T slueere | [rene [L900 LS/QA017/F01-00 ‘COLLOID THE MANUFACTURING SOLUTION 1 MAKEUP THE MANUFACTURING SOLUTION FINAL REQUIRED VOLUME WITH PURIFIED WATER _ BULK ANALYSIS | BOTTLE WASHING BOTTLE FILLING & SEALING & LABELLING { INPROCESS CHECKS : FILL VOLUME& SEAL INTIGRITY AND LEAK TEST t PRIMARY PACKING T SECONDARY PACKING COMPLETE ANALYSIS64 MASTER COPY LEO STAR HEALTH CARE PRIVATE LIMITED PROCESS VALIDATION PROTOCOL Product Name Protocol Number FEPANIL 125 MG here PAEDIATRIC ORAL SUSPENSION Se ee zip Poor 6.3 LIST OF PROCESS EQUIPMENT, INSTRUMENTS AND UTILITIES WITH QUALIFICATION AND CALIBRATION STATUS ‘S.No. [NAME OF MACHINE/] EQUIPMENT poe cuNa QUALIFICATION DONE ON ‘Sugar melting vessel ; 1Q :18/04/2021 1 eos ae LsPD/sMoo1 —_| 0Q:18/04/2021 aii PQ:18/04/2021 Syrup preparation vessel Sena 2 eee. a LS/PD/SPO01 0Q:18/04/2021 an PQ:18/04/2021 5 1Q :18704/2021 3 Se Or LS/PD/HZ001 0Q:18/04/2021 pou PQ:18/04/2021 | Homogenizer 5007 Pappnapeaent yeu capacity 1Q 11870472021 5 | Filter press LS/PD/FPOD] =| 0Q:18/04/2021 PQ:18/04/2021 1Q :18/04/2021 6 | Stree aay 7 Lsp/svool —_| 0Q:18/04/2021 ae PQ:18/04/2021 1Q :1870472021 7 | Storage ag ee LspPp/svoo2 —_| 0Q:18/04/2021 i capacity SS ti PQ:18/04/2021 BATCHES SELETED FOR VALIDATION: Three batches are to be selected to perform process validation. Since this is prospective process verification, 3 consecutive baiches from subsequent campaigns shall be conducted. An interim process validation report for batches completed in each campaign shall be prepared for release of batches A consolidated process validation report is prepared after completing 3 prospective validation batches, Chemical, physical and microbiological testing in accordance with product specifications demonstrates that the process is in control, can deliver product within expected specifications and is suitable for normal production. LS/QA017/FO1-0065 6.6 67 MASTER COPY | LEO STAR HEALTH CARE PRIVATE LIMITED PROCESS VALIDATION PROTOCOL FEPANIL 125 MG PARACETAMOL PAEDIATRIC ORAL SUSPENSION [usrernirns ——[erenedees] Tuners] ee ‘Validation batch flow as follows: The following batches are selected for validation, Product Name Generic Name Protocol Number S.No. B.No. L FSL22M01 2. FSL22M02 3. FSL22N03, BATCH OPERATIONS: The manufacturing activity shall be carried out as per following Batch Manufacturing Record (BMR) na Document Name Document No. Effective Date Batch Manufacturing record of Effective from B. No: 01" | Paracetamol Paediatric Oral | LS/BMR/LLFE1-00 | FSL22M01 Suspension(Fepanil 125) API INPUTS AND IT’S VENDOR DETAILS: An APIs details used as an input for manufacturing of Paracetamol Paediatric Oral Suspension are mentioned below: Name of API/ SNe eee Name of Vendor Approval Status L Paracetamol Mfg by : Sri Krishna Pharma Approved | RAW MATERIAL INPUTS AND VENDOR DETAILS Paracetamol paediatric oral suspension shall be manufactured with Paracetamol and other excipients. ‘The input details of raw materials are mentioned below: U s. Name of the Raw : 7 ve ils No. Material Me Std. Quantity ‘endor Detai ‘aracetamol* Mfg & supply: Srikrishna are fee tee Pharmaceuticals LS/QA017/F01-00MASTER COpV : | LEO STAR HEALTH CARE PRIVATE LIMITED PROCESS VALIDATION PROTOCOL Product Name FEPANIL 125 MG Generic Name PARACETAMOL PAEDIATRIC ORAL SUSPENSION Protocol Number LS/PVP/LLFE1 Bifective Date pln feora Revision Number 00 Page No. s, NameoftheRaw | © Nee pail 2 Std. Quantity Vendor Details 2. | Sorbitol solution 70% kg} 17780 PAG? Meme petortc oa ih Supply: Pinima life sciences ar = ‘Mfg : kaleshwari refined industries 17,800 i : 3 ke hi Supply : Sri sai durga traders Mig: Corel pharma Supply : Sri sai 4 kg} 2.220 aga ls : ae Mig : Fufeng Supply : Sri sai durga traders Mig : Nebula Supply : Sri sai durga 6 | Propyl paraben kg} 1.000 eect pee reat ty | 5500 Mig Lax flavours Supply CS enterprises 8 | Erythrosine colour kg 0.062 Mfg: ROHA Supply : Sri sai durga traders 9 | Sexi ydroxideCfor : as Mig : Ganshyam Carbopol) 8 : Supply : Sri sai durga traders Sodium hydroxide(for pA Mfg: Ganshyam 10° | adjustment) kg ime Supply : Sri sai durga traders T1_| Sucrose ke |__ 122.000 Sodium hydroxide(for 20% Mig : Ganshyam 12 | sotution) pear Supply : Sri sai durga traders , ; Mig : Ganshyam 13. | Sodium hydroxide kg} 1.050 Biel oH sal rea steal aa Mig patel 14. | Citric acid monohydrate kg} 2.220 sia Su araiieteadss : Mig : suheka Ind 15, | Bronopot kg} 0.200 supply : Sa oat darga wader 16_| Purified water QSt0 2000L * Overages Added: Paracetamol 3. LS/QA017/F01-00MASTER COPY LEO STAR HEALTH CARE PRIVATE LIMITED PROCESS VALIDATION PROTOCOL Product Name :_| FEPANIL 125 MG Generic Name PARACETAMOL PAEDIATRIC ORAL SUSPENSION Protocol Number | : | LS/PVP/LLFE1 Effective Date |: | 2//n[ror2- Revision Number 00 Page No. 13 of 19 6.8 PACKAGING MATERIALS USED IN PACKAGING AND VENDOR DETAILS The below mentioned packaging materials shall be used for packaging of the product Paracetamol paediatric oral Suspension, S.No. Packing material Quantity Unit Vendor Details Omi round amber 1 | coloured pet bottles 33,666 No’s Mfg & er SNJ Synthetic 25mm neck ame 25 mam alumimium blue 2 | Ropp caps with printed | 33,666 No’s Mfg & Suppl: Alu Top Fepanil logo Fepanil 125 mg printed 3 sireilt ae 35,000 No’s Mfg & Suppl: Gayathri Labels 4 | 10 Measuring cups 33,666 No's| Mfg & Suppl :Eco Pharma 5 | 5 Ply Shippers 306 No's Mig & Suppl: Sai Spurthi | 6 | Partitions 612 No’s Mig & Suppl: Sai Spurthi Packing ; “Mig & Suppl: Sai Sparthi 7 | 3PlyPads 306 No’s i 8 | 60mm Bopp Tapes 18 No’s - 69 CRITICAL PROCESS PARAMETERS: ‘The Critical process parameters are involved in the process and to be monitored during the validation. The details are mentioned below. [Step No. Operation Parameters Justification Sugar syrup Continue stirring tll suerose PS 1 : : uniformly to obtain a manufacturing dissolves completely. At 80 to 90°C | “! : uniform solution. Preservatives help ae ‘Add the preservatives in sugar | prevent the growth of 2 ae syrup with continuous stirring for _ | microorganisms. Hence Leena 30 minutes thorough mixing is to be done. Disperse and dissolve colour - 4 Addition of colour | Erythrosine Supra in water and add_| 7° ™8Ke uniform color : : throughout the solution. to manufacturing vessel with LS/QA017/F01-00MASTER COPY LEO STAR HEALTH CARE PRIVATE LIMITED PROCESS VALIDATION PROTOCOL ProduetName | : | FEPANIL 125 MG Generic Name PARACETAMOL PAEDIATRIC ORAL SUSPENSION Protocol Number LS/PVP/LLFE1 Effective Date ; Drow Revision Number Page No. stirting for 30 min rn ‘Add the Carbopol sh Addition of Carbopol slurry insugat | 7. make the Carbopol 8 ‘Carbopol slurry syrup with continuous stirring for slurry without lum, | Pret 30 minutes z ee Addition of Xanthan | Ad4 the Xanthan gum in sugar To make the Carbopol 8 ca syrup with continuous string for | {0 mae Core pete 30 minutes 7 7 i Addition of uae caren 1 ing | T0 make the Carbopo! paracetamol sluny | ese ME | slurry without lumps 7 Te i Addition of Banana | Add banana flavour to mfg tank | T° ™ake uniform 9 - ae j__ | flavour throughout the flavour with continuous stizing for 15 min : solution. To have a final uniform he ‘Volume Makeup and | Make up the volume with Purified haeeoeoee 2 eee final stirring ‘water and stir for 30 min. ae conforming to approved specifications. 6.10 IN-PROCESS AND FINISHED PRODUCT TESTS: 6.10.1 IN-PROCESS TEST: {All the In process steps shall be done as per controlled procedures and parameters shall be checked as per this protocol. Following in-process test parameters are involved in the manufacturing process of Paracetamol paediatric oral suspension. LS/QA017/F01-00MASTER Cnpv LEO STAR HEALTH CARE PRIVATE LIMITED PROCESS VALIDATION PROTOCOL Product Name : | FEPANIL 125 MG Generic Name PARACETAMOL PAEDIATRIC ORAL SUSPENSION Protocol Number | : | LS/PVP/LLFEL [ Ettective Date [:] 24) vfrerr— Revision Number |: [_PegeNo. || 15 of 19 Tn-process specification reference LL/SPC/PFEITH/01-00 Te bi rene Operation Test Specification Seed performed Op1 | Sugar syrup ae Clear syrup Free from foreign | Production | manufacturing arity particles. and IPQA ‘Addition of Op2 | preservatives, colours | (4, Suspension with Approved Production and addition of ee colours and flavours. and IPQA flavours(description) Suspension with Approved Deseription colours and flavours. ae pH(at2s°c) — | 4.010690 ac Weight per mL ; aa 1.00 to 1.50 g/ml ac “Viscosity (at 25°) 400-1200 ops ac a Op 10 | After Batch filtration fees 7 Each ral 118.75 mg to 131.25 mg e aay (95.0 to 105.0%) Q Paracetamol IP 125.0 mg Assay by UV Each § ml 118.75 mg to 131,25 mg ge contains (95.0 t0 105. Paracetamol IP 125.0 mg 6.11 IN-PROCESS SAMPLING PLAN: Sampling plan for In-process test parameters, Number of Samples, Frequency of sampling and sampling locations are defined below: Collect approx. 30 ml of syrup at each location through a cleaned sampler into a cleaned sample bottle and put appropriate label on it. Send the samples to QC for analysis. Ref. Specification No.: LL/SPC/IPFEV/IH/01-00 LS/QA017/FO1-00MASTER Copy LEO STAR HEALTH CARE PRIVATE LIMITED .OCESS VALIDATION PROTOCOL FEPANIL 125 MG PARACETAMOL PAEDIATRIC ORAL SUSPENSI! vsrvruire: ——[eeieome | lve ‘Sampling plan details for each batch: Operation No.: 10 Product Name Generic Name Protocol Number Revision Number Sapling : : SN. | troueney Sampling Location TT Kner 20 min, | Sa@81¢ Hom botiom of te syrup preparation vessel 2H Sample from middle of the syrup preparation vessel 3 . Sammple from top of the synip preparation vessel TT xper 30min. | Sample tfom botiom of the syrup preparation vessel 2 a Sample from middle of the syrup preparation vessel stirring : 3 Sample from top of the syrup preparation vessel see : ‘Sample from bottom of the syrup preparation vessel 2 After 40 min. [Semple from middle of the syrup preparation vessel string ° 3 ‘Sample from top of the syrup preparation vessel Note: The composite sample should be representative of the bottom, middle and top of the vessel. If composite sample pH found does not comply, additional samples to be collected from the Syrup Preparation Vessel and send to QC for analysis. LS/QA017/F01-00