PPIA 1211VA ITZERLAND EL CENTRAL AX CENTRAL 417913111WWWWHOINT - PDF document

PPIA 1211VA ITZERLAND EL CENTRAL AX CENTRAL +417913111WWWWHOINT Hetero Labs Ltd, Unit 5Telangana, Ind27 August and5 September 2020This inspection reporthe property of the WHContact: prequalinspection@who.intPage of Prequalification UnitInspection servicesWHO INSPECTIONREPORTDesk Assessment of Finished Product Manufacturer Part 1 General information Company information Name of Manufacturer Hetero Labs Ltd, Unit 5 Corporate address of manufacturer Hetero Lab s Ltd. Hetero Corporate,A2, Industrial Estates, SanathNagar,Hyderabad 500018, Telangana, India I nspected site Name & address of manufacturingsite Hetero Labs Ltd, Unit 5 Survey No 439, 440, 441 & 458 TSIICormulation SEZ, Polepally Village, Production Bl oc k/Unit Blocks: V, VA and VC Manufacturing license number No 50/ MN/AP/2009 /F/R, Form 25, valid up to 18/12/2024 Desk assessment details Start a nd end dates of review 1 7 - 27 August 2020 and 0 1 – 0 5 September 2020 Product s covere d by this desk assessment 1. Lamivudine/Nevirapine/Zidovudine Tablet, Fi lm - coated 150mg/200mg/300mg 2.Efavirenz/Emtricitabine/Tenofovir disoproxil fumarate Tablet, Filmcoated 600mg200mg/300mg3.Valganciclovir (hydrochloride) Tablet, Filmcoated 450mg4.Abacavir (sulfate)/Lamivudine Tablet, Filmcoated 600mg/3005.favirenz/Lamivudine/Tenofovir disoproxil fumarate Tablet, Filmcoated 400mg/300mg/300mg6.Lamivudine/Zidovudine Tablet, Filmoated 150mg/300mg7.Lamivudine/Tenofovr disoproxil fumarate Tablet 300mg/300mg8.Efavirenz/Lamivudine/Tenofov 18. Mo xif loxacin (hydrochloride) 400 mg PPIA 1211VA ITZERLAND EL CENTRAL AX CENTRAL +417913111WWWWHOINT Hetero Labs Ltd, Unit 5Telangana, Ind27 August and5 September 2020This inspection reporthe property of the WHContact: prequalinspection@who.intPage of 19. Abacavir (sulfate )/Lamivudine Tablet 60mg /30 mg List of document s submitted 1) Infarmed inspection (21 – 24 January 2020) prelimina ry report 2)Heteroinitiresponseated 21February 20203)Hetero response to the preliminary report, dated May 20204)Infarmedinspection1 24 January 2020)nal report5)Documents submittedafter final report6)EurdaGMPcerticat

e SMF006/001/220, dated 12y 20207)Infarmedinspection(21 January 2019report 8)Hetero initial response toinspectorAntonio Azevedo9)Hetero initial response toinspectr DrJudit Geher10)Hetero initial response toinspectorMr. Pedro Marques11)Hetero initial response toinspectorto Infarmednspectioneport12)EurdaGMPcertificate FI006/001/2019, dated April 201913)USFDA establishment inspectionrepor, dates of inspection 8 19April 2019, 2 26 April 201914)FDA establishment spectionreporletter, dated 16 January202015)USFDA Form 48316)CAPAs to USFDA establishment inspectionreport17)Minutes of meeting on the Teleconference between FDA and Hetero, date of meeting18ptember201918)Health Canada(HC), dates of inspection19)inspection exit notice deficienciesand cover letter20)APAs to HC inspection report21)HC clarification letter 22)Hetero responseto HC clarification letter23)inspectionclosure letter24)List of SRA inspection in last 5 years25)Declaration self inspection26)Declarationout of stock situation27)Declaration no schedules upcoming inspections28)GMP certificateL.Dis.No.33261/TS/2020. ated 202029)SOP CQA01002 Product Quality Review 30)SOP CQA02901 Data trending31)LicenseretentiocertificatelicenseNo 50/MN/AP/2009/F/R, Form 25, valid up o 18/12/202432)DA warningletter, dated 15 August 2017, related to the inspection 7 16 December 201633)SMF012434)List of products manufactured at Blocks V, VA and VC35)BMR/BPR/master batchcordsanalytical raw dataand PQRs:Sofosbuvir Tablet 400mgb)Dolutegravir Tablet 30mgLinezolid Tablet600mgd)Efavirenz / Emtricitabine /Tenofovir Disoproxil Fumarate Tablet 600mg/200mg/300mg: BMRblendEfavirenz / Lamivudine / Tenofovir Disoproxil Fumarate Tablet 600mg/300mg/300m f) Dolutegravir, Lamivudine, Tenofovir T ablet 50mg/300mg/300mg PPIA 1211VA ITZERLAND EL CENTRAL AX CENTRAL +417913111WWWWHOINT Hetero Labs Ltd, Unit 5Telangana, Ind27 August and5 September 2020This inspection reporthe property of the WHContact: prequalinspection@who.intPage of g) Lamivudi ne, Te nofovir Tablet 300mg/300mg h)Daclatasvir Tablet 60mgMoxifloxacin Tablet 400mgLamivudine, Zidovudine Tablet 150mg/300mgk)Valganciclovir Tablet 450mgAbacavirsulfate, Lamivudine tablet 60mg /300mgEntecavir Tablet 500n)Entecavir

Tablet 100 mg o)Abacavir, Lamivudine tablet 60mg, 30mgp)Artemether, Lumefantrine 20mg, 120mg q)Dolutegravir Tablet 50mg Efavirenz, Lamivudine, Tenofovir Tablet 400mg, 300300Lamivudine, Zidovudine, Nevirapine Tablets 150mg, 300mg, 200mg Any docu ments missing? N/A Part 2 S u mmary of SRA/NRA insp ection evidence considered (from most recent to last) and comments I NFARME D ationalAuthority of Medicines and lth Products,PortugalPortugal National Authority of Medicines and Health Pr od ucts Dates of insp ection: 21 – 24 Jan uary 2020 Type of inspection: Follow - up and GMP certificate renewal inspe cti on Block/Unit: Block V and Block V - A of Unit V Bloc k V - B Type of p roducts/Do sag e forms covered: E n t e c a v i r A c c o r d , 0 . 5 m g an d 1 m g , f il m - c oa t e d tablets WHO products under PQere not specificallycovered USFDA , USA Dates of i nspection: 18 – 19 A pril 2019, 22 – 26 A pr il 2019 Type of inspecti on: GMP surv eillance i nsp ect ion Block/Unit: Block V , V - A and V - B Type of products/Dosage forms covered: Pantoprazole So d ium Delayed R el e a s e Tablet s USP 20mg antoprazole Sodium Delayed ease Tablets Rosuvastatinalcium Tablets uvastatinCalciumTablet0 vastatin Calcium Tablets 20Rosuvastatin alcium Tablets 40Levofloxacin Tablets 250LevofxacTab50LevofloxacTablet750Aripzole TabAripzole Tab10 mgrtaTablets40 mgartaTablets 0 mg V a l s arta n Tablets 1 60 mg PPIA 1211VA ITZERLAND EL CENTRAL AX CENTRAL +417913111WWWWHOINT Hetero Labs Ltd, Unit 5Telangana, Ind27 August and5 September 2020This inspection reporthe property of the WHContact: prequalinspection@who.intPage of V a lsarta n Tablets 320 mg ValacycloviTablets 100 mgValacyclovir Tabts 00 mgTelmisatan Tablets USP 20 mgTelmisaan Tablets USP 0 mgTelmisatan TabletsSP 0 m WHO FPPs were not specificall y cove red I NFARME D ational Authority of Medicines and Health Products, Portugal) Por tugal D ates of inspection: 21 – 2 5 Ja nuar y 2 0 19 Type of inspection: GMP i nspect ion Block/U ni t: Block V and Block V - A of Un it V Block V - B Type of p

roducts/Dosa ge forms covered: E n t e c a v i r 0 . 5 m g an d 1 m g , f il m - coa t e d t a b l e t s H ealth Canada , Canada Date s of inspection: 3 rd to 6 th December 2018 Type of inspect ion: R e - insp ecti on Bl ock/Unit /Workshop : Block s V, VA a n d VB F PP s covered: 1. Sildenafil C itrate Tablets 25 mg , 50 mg & 100 mg 2.Clopidogrel tablets 75 mg & 300 mg3.Pioglitazone Tablets 15 mg, 30 mg &45 mg4.Montelukast sodium 10mg table5.Montelukast sodium Chewable Tablets4 mg & 5 6.Olanzapine tablets 2mg, 5 mg, 7.5mg,10 mg, 15 mg & 20 m7.Donepezil Tabletsmg & 10 mg8.Escitalopram tablets 10 mg, 15 mg & 20 mg9.Tolterodine IR tablets 1 mg & 2 m10.Irbesartan Tablets 75 mg, 150 mg & 300 mg11.Quetiapine Fumarate IR tablets 25 mg, 100 mg, 150 mg, 200 mg 00 12.Aripiprazole Tablets 2 mg, 5 mg, 1mg, 15 mg, 20 mg 30 mg WHO products under PQ were not specifically covered Part 3 Summary of the last W HO inspec tion Da te of insp ection conclusion of mostrecentWHO inspection The last WHO inspection was conducted from 30 October to 3 November 2 017 with the resolution stating, sed on the areas ispected, the people met and the documents reviewed, and considering the findingsof theinspection,includingthedeficiencieslistedtheInspectioneport,deononthecomplianceof Hetero Laboratories Limited (UnitV) cated at, Sy. No. Part o439, 440, 441 & 458, APIIC,Pharma SEZ,Polepall(village),Jadcherla(Mandal),MahaboobNagar(Dist.),509301,IndiawithWHOGMP guidelines will be made aftemanufacturer's response to the deficiencies hasbeassessed. CAPAs werbmitted and assessedby the PQT: Inspection Team and the inspection f ollowing the review of the C APA , was cl osed on 24 November 2019 as compliant. PPIA 1211VA ITZERLAND EL CENTRAL AX CENTRAL +417913111WWWWHOINT Hetero Labs Ltd, Unit 5Telangana, Ind27 August and5 September 2020This inspection reporthe property of the WHContact: prequalinspection@who.intPage of S um mary ofmanufacturing activitiesas of November 2017 Hetero Labs Unit V has three b locks manufact u ring blocks (Bloc k - V, Bloc k - VA , and BlockVB) on the site withdifferent multiproduct formulation nd packaging mo

dules. Block V and Block VA werein theinspectionscope.CytotoxicproductsweremanufacturedBlockwhich was out of the scope of thiinspection. Gen eral inforonabout the company and nufacturing site as ofNovember 2017 Hetero Labs Unit V has three b locks man ufactu ring blocks (Bl ock - V, Block - VA, and Block) on the site withdifferent multiproduct formulation and packaging modules. Block V and Block VA werein theeconscope.CytotoxiproductsweremanufacturedBlockwhich was out of the scope f thisinspection. F ocus o f the last WHO inspection Efavirenz Tablet s 600mg Efavirenz/Emtricitabine/Tenofovir Tablets 600/200/300 mgLamivudine/Nevirapine/ZidovudineTablets 150/200/300Lamivudine/Tenofovir Tablets 300mg/300mLamivudine/ZidovudineTablets 150mg/300mgLinezolid Tables 600mgMoxifloxacin Tablets 400mgAbacavir (asSulfate) + Lamivudine 600mg/300mSofosbuvir Tablets 400mgEntecavir Tablets 0.5mgntecavir Table1.0Acyclovir Tablets 400mgValganciclovir (hydrochloride) Tablet, Filmcoated 450m favirenz/ Lamivudine / Tenofovir Disoproxil FumaraTablets 600m g/300mg/300mg Ar eas inspected Documen t reviewed including but not limited OrganizationChartJob descriptions for keypersonnelProduct QualityReviewuality RiskManagementManagentReviewsponsibilities of the quality units aproductionComplaints andRecallsDeviation control and changecontrolOOS andinvestigationCAPAprocedureValidation andqualificationData integritySamplingand testing ofmaterialsBatchprocessingecordsMaterials managementsystemSitevisited: O ral Solid Dosage (O SD) Prod uction opera tions PPIA 1211VA ITZERLAND EL CENTRAL AX CENTRAL +417913111WWWWHOINT Hetero Labs Ltd, Unit 5Telangana, Ind27 August and5 September 2020This inspection reporthe property of the WHContact: prequalinspection@who.intPage of Stability study QC laboratory and control sy stem Starting material and finished Goods war ehouse Out of scope and restrictions (last WHO inspec tion) Products n ot s ubmitted t o WHO for Pre qualification Abbreviat i ons Meaning A PI Active pharmaceuti cal ingredient BMR Batch man ufacturing record BPR Batch producti on recor d CAPA Correc tive and p reve ntive action FPP Fi

n is he d pharmaceut ical product GMP Good manufacturing p ractices PQR Product quality review SMF Site mast er file SOP Standard operati ng procedure Part 4 S ummary of th e assessm ent of supporting docum entat ion a)Lisf all regulatory inspecperformed inthe last 5 years and their outcomes Sr. No Regulatory agency D ate s of Ins pection Out come 01 I NFARMED – Portugal 21 st to 24 th January 2020 Complies 02 FMHACA – Ethi opia (Food Medicine and Healthcare Administration and control Authory of Ethiopia 30 th Septe mber to October 2019 Complies 03 SF DA - Saud i (Saudi Food and Drug Administration) 15 th to 17 th July 201 9 Complies 04 USFDA ( United States Food an d Drug Administration) 18 th to 26 th Apri l 2019 Official A ction Indicated (OAI) lett er received 05 NDA – Uganda (Natio na l Drug Authority) 18 th to 19 th March 2019 Complies 06 IN FARMED – Portugal 21 st to 2 5 th January 2019 Complies 07 Health Canada , C anada 3 rd to 6 th December 2 018 Complies 08 TF DA – Tanzania (Ta nzania Food a nd Drugs Auth ority) 8 th t o 9 th October 2018 Com pl ies 09 MOH – Be l arus (Ministry of Health) 30 th to 31 st J uly 2018 Complies 10 MOH - R ussia (Ministry of Health) 12 th to 14 th July 2018 Complies 11 Z aZiBoNa (Zambia, Zimbabwe, Botswana, Namibia) 20 t h to 24 th April 2018 Complie s 12 MOH – Oman (Mintry of Health) 16 t h to 17 th April 201 8 Complies PPIA 1211VA ITZERLAND EL CENTRAL AX CENTRAL +417913111WWWWHOINT Hetero Labs Ltd, Unit 5Telangana, Ind27 August and5 September 2020This inspection reporthe property of the WHContact: prequalinspection@who.intPage of Sr. No Regulatory agency D ate s of Ins pection Out come 13 INVIM A – Colombia (Colombia Hea lth Authority) 4 th to 8 th December 201 7 Complies 14 MOH – Yemen (Ministry of Health ) 2 nd December 20 17 Complies 1 5 ANVISA – Brazil (Nat ional H

ealth Surveillan ce Agency) 6 th to 1 0 th November 2017 Co mplies 17 NAFDAC (N ational agency for food and drug administration and control) 26 th to 27 th April 2017 Complies 1 8 MCC – So uth Af rica (Medicines Co ntrol Counc il ) 18 th to 21 s t March 2017 Complies 19 USFDA , USA ited States Food and Drug Administration) 7 th to 16 th Decemb er 2016 Warning L etter (WL)received 20 MOH - Russia (Ministryof Health) 31 st May to June 2016 Co mplies 2 1 LAGeSo – Berlin , Germany (Berlin Health Authority) 29 th Februa ry 2016 to March 201 Com plies 22 I NFARMED – Portugal (The National Institute of Pharmacy and Medicines)(European Union) 1 st to 4 th February 2016 Complie s 2 3 NMPB – Sudan (National Medicines and PoisonsBoard) 30 th November to December 2015 Complies 24 PPB – Keny a (Pharmacy a nd Poisons Board) 31 st August to 1 st Sept ember 2015 Complies 25 CO FEPRIS – Mexico 3 rd to 1 4 th August 2015 Complies Manufacturing authorization granted by national authoritiesLicenseNo 50MN/AP/2009/R, Form 25, valid up to 18/12/2024GMP certificateL.Dis.No.33261/TS/2020. ated 2020Site master fileSMFsubmitted and reviewed. SMF written according to the WHO TRS No. 961, Annex 14List f all the proucts nd dosage forms manufactured onsite:Totally 151 APIs are manufacturedat Uit heratic groupsList provided in mail1)AntiViral2)AntiAllergic3)Antidepressants4)ntiabetic5)alarial6)AntDiarrhoea7)AntiAlzheimer PPIA 1211VA ITZERLAND EL CENTRAL AX CENTRAL +417913111WWWWHOINT Hetero Labs Ltd, Unit 5Telangana, Ind27 August and5 September 2020This inspection reporthe property of the WHContact: prequalinspection@who.intPage of 8)Antythmi9)AntAsthmatic10)AntBacterial11)Antagulant12)AntDementia13)AntiEpileptic14)AntiFungal15)AntiHyperlipidemic16)AntiHypertensive17)AntiMuscuran18)Antinflammatory19)Platelet 20)Antiychotic21)AntiTB22)enign ProstateHyperplasia23)Calcimimetic24)Chronic Hepatitis25)Dsypareunia26)Erectile Dysfunction27)Fibromyalg28)Gluco Cartico SteroidGout flares & Familial Mediterranean Fever29)

Huntington’s chorea30)Immunomodulatory31)Inhibit Gastric acid Secretion32)Irritable Bowel Syndrome with Diarrhea33)Nonbenzodiazepine hypnotic34)Nonnucleoside reverse transcriptase Inhibitor35)Phosphodiesterase type 5 inhibitor & Selective Serotonin Reuptake inhibitor36)Proton Pump Inhibitor37)Platelet Inhibitor38)Selective vasopressin V2receptor antagoni39)Stimulant Laxative40)Thrombopoietin receptor agonist41)Treatment for male pattern hair loss Androgenetic Alopecia42)Treatment of Epilepsy & peripheral neuropathic pain43)Xanthine oxidase inhibitor44)Pulmonary Fibrosis45)TrematodicideMost recent product quality reviewPQRof the concerned WHO productbmitted1)Abacavir sulfate & Lamivudine 60mg/30mg2)Artemether & Lumefantrine tablets 20mg120mgubmittedand hecked1)Daclatasvir tablets 30mg2)Daclatasvir tablets 60mg3)Dolutegravir tablets 50mg4)olutegravir (Sodium)amivudine/Tenofovir disoproxil fumarate tablets 50mg/300mg/300mg PPIA 1211VA ITZERLAND EL CENTRAL AX CENTRAL +417913111WWWWHOINT Hetero Labs Ltd, Unit 5Telangana, Ind27 August and5 September 2020This inspection reporthe property of the WHContact: prequalinspection@who.intPage of 5)Entecavir1 mg tablets6)Linezolid 600 mg tablets 7)Tenofovr Disoproxil Fumarateand Lamivudine tablets 300 mg/ 300 mg 8)Lamivudine,Nevirapine, Zidovudine tablet 150mg/200mg/300mg9)Efavirenz, Lamivudine, Tenofovir tablet 600mg/ 300mg/30010)Efavirenz, Lamivudine and Tenofovir disoproxil fumarate tablets 400mg/300mg300mgSubmittedand eviewed1)Entecavir0.5 mg tablets2)xifloxacin Hydrochloride 3)Sofosbuvir tablets 4004)amivudine and Zidovudine tablets 150 mg/300 mg 5)Valganciclovir Tablet 450 mg6)Efavirenz / Emtricitabine / Tenofovir Tablet 600mg / 200mg / 3007)Abacavir / Lamivudine Tablet 600mg / 300mgBatch manufacturing and packaging recordincluding the analyticalpart, for the most recently released batch of relevant productSubmitted and checked1)Sofosbuvir Tablet 400mg2)Dolutegravir Tablet 30mg3)Linezolid Tablet600mg4)Efavirenz / Emtricitabine / Tenofovir Disoproxil Fumarate Tablet 600mg/200mg/300mg5)Efavirenz Lamivudine / Tenofovir Disoproxil Fumarate Tablet 600mg/300mg/300mg6)Dolutegravir, Lamivudine, Tenofovir Tablet 50mg/300mg/300mg7)Lamivudine, Tenofovir Tab

let 300mg/300mg8)Daclatasvir Tablet 60mg9)Moxifloxacin Tablet 400mg10)Lamivudine, Zidovudine Tablet 150mg300mg11)Valganciclovir Tablet 450mg12)Entecavir Tablet 500Submitted and reviewed:1)Abacavir sulfate, Lamivudine tablet 60mg /302)Entecavir Tablet 13)Artemether, Lumefantrine 20mg, 120mg4)Efavirenz, Lamivudine, Tenofovir Tablet 400mg, 3003005)Lamvudine, Zidovudine, Nevirapine Tablets 150mg, 300mg, 200mg6)Daclatasvir (dihydrochloride) Tablet, Filmoated 30mg7)Abacavir (sulfate)/Lamivudine Tablet 60mg/30mg Master batch manufacturing and packaging recordof the productof interest:Submittedd checked1.Valganciclovir Tablet 1)Lamivudine, Zidovudine Tablet 2)Lamivudine, Tenofovir Tablet 3)Efavirenz, Lamivudine, Tenofovir Tablet 4)Dolutegravir, Lamivudine, Tenofovir Tablet PPIA 1211VA ITZERLAND EL CENTRAL AX CENTRAL +417913111WWWWHOINT Hetero Labs Ltd, Unit 5Telangana, Ind27 August and5 September 2020This inspection reporthe property of the WHContact: prequalinspection@who.intPage of 5)Daclatasvir Tablet30mg 6)Daclatasvir Tablet 60mg 7)Linezolid Tablets600mg 8)oxifloxacin Tablet 400mg 9)Dolutegravir Tablet 50mg 10)Efavirenz,Emtricitabine, Tenofovir Tablet 11)Abacavir, LamivudineTablet 12)Sofosbuvir Tablet 400mg 13)Entecavir Tablet 0.5 mg 14)Entecavir Tablet 1mg 15)Abacavir, Lamivudine tablet 60mg, 30mg16)Artemether,Lumefantrine20mg, 120mg 17)Dolutegravir Tablet 50mg 18)Efavirenz, Lamivudine, Tenofovir Tablet 400mg, 30030019)Lamivudine, Zidovudine, Nevirapine Tablets 150mg, 300mg, 200mg If any ofthe products are sterile, the completed batch recordsor the most recent media fill validatn that isrelevant toproductsof interest and report on its outcome: N/ARecalls in the past threeyears related to products with quality defects:32 batches of different products havebeen recalled in last3 yearsConfiration by thenior qualitassurancerepresentative that afull selfinspection or externaaudit dedicated to the produc) has beenperformed and allmatters dealt with:Declaration submitted full selfinspection or external audit dedicad to the poduct) has beeperformed nd all matters dealt withopy of any warning letter, or equivalent regulatory action, issued by any authority to which the site provides or has applied to provi

de the product:DA warning letter, dated 15 Agust017, relatd to the inspetion 7 16December 2016Outoftock situations:Declarationsubmitted o out of stock situationdditional documents subittedSOP “Product Quality ReviewSOP CQA02901 “Data trending Part 5 Conclusion – Desk asse ssment o utcome Based on the previous WHO inspecions and onthe GMPevidence received and rviewed, it is considered that a desk assessmentis acceptable in lieu of a WHO onsite inspection. The siteHetero Labs Ltd, Unit 5manufacturingblocksV, VA and VCated Survey No 439, 440, 441 & 458TSIIormulaon SEZ, Polepally Village, Jadcherla (M), Mahboob Nagar District, Telangana, 509301, Indiais considered to be perating at anacceptable level ofcompliance with WHO GMP guidelines. This WHOPIR willremain valid for 3 years, provided that the outcome of aninspection conducted during this period is positiv PPIA 1211VA ITZERLAND EL CENTRAL AX CENTRAL +417913111WWWWHOINT Hetero Labs Ltd, Unit 5Telangana, Ind27 August and5 September 2020This inspection reporthe property of the WHContact: prequalinspection@who.intPage of Part 6 List of guideli nes r efer enc e d in this inspection repo rt 1.O good manufacturing practices for pharmaceutical products: main principles. WHO Experommittee on Specifications for PharmaceuticalPreparations. FortyeighReportGeneva,World ealth Organization, 2014 WHO Technicl Report Series, No. 986), Annex 2.Short name: WHO TRS No. 986, Annex 2http://www.who.int/medicines/areas/quality_safety/quality_assurance/exert_committee/trs_986/en/2.WHO good manufacturing practices for active pharmaceutical ingredients.WHOExpertCommittee on Specifications for Pharmaceutical Preparations. Fortyourth ReportGeneva, World Health rganization, 2010 (WHO Technical Repot Series, No. 957), Annex2. Short name: WHO TRS No. 957, Annex 2ttp://www.who.int/medicines/publications/44threport/en/3.WHO good manufacturing practices: water forpharmaceutial use. WHO Expert Committee on Specifications for Pharmaceutical Preparations. FourthsixReportGeneva,World Health rganization, 2012 WHO Technical Report Series, No. 970), Annex 2.Short name: WHO TRS No. 970, Annex 2ttp://www.who.int/medicines/areas/quality_safety/quality_ass

urance/expert_committee/trs_970/en/4.WHO guidelines for samplingof pharmaceutical products and related materals. WHO Expert Committeeon Specifications for Pharmaceutical Preparations. Thirtninth ReportGeneva, World Health Organization, 2005 (WHO Technical Report Series, No. 929), Annex 4.Short name: WHO TRS No.929, Annex 4http://whqlibdoc.who.int/trs/WHO_TRS_929_eng.pdf?ua=15.Guidelineson heating, ventilation and airconditioning systems for nonterile pharmaceutical products. WHO Expert Committee on Specifications forPharmaceutial Preparations. Fiftycond ReporGeneva, World Health Organization, 2018 (WHO Technical Report Series,No. 1010), Annex 8. Short name: WHO TRS No. 1010,Annexhttp://www.who.int/medicines/areas/quality_safety/quality_assurance/expert_committee/trs_1010/en/6.Supplementary guidelines on good manufacturing practices:validation.WHO Expert Committee onSpecifications for Pharmaceuticalparations. Fortieth ReporGeneva,World Health Organization, 2006 WHO TechnicalReport Series, No. 937), Annex 4.Shorame: WHO TRS No937, Annex 4http://whqlibdoc.who.int/trs/WHOTRS_937_eng.pdf?ua=17.WHO Good Practices for Pharmaceutical Quality Control Laboratories. WHO Expert Committee on Specifications for Pharmaceutical Preparations. Forfourth ReportGeneva,World Health ganization, 2010 (WHO Technical ReportSeriesNo. 957, Annex 1. Short name: WHO TRS No. 957, Annex 1http://www.who.int/medicines/publications/44threport/en/ PPIA 1211VA ITZERLAND EL CENTRAL AX CENTRAL +417913111WWWWHOINT Hetero Labs Ltd, Unit 5Telangana, Ind27 August and5 September 2020This inspection reporthe property of the WHContact: prequalinspection@who.intPage of 8.WHO Good Practices for Pharmaceutical Products Containing Hazardos Substances. WHO ExpertCommitteeon Specifications for Pharmaceutical Preparations. Fortyfourth ReportGeneva, Worldalth Organization, 2010 (WHO TechnicalReportSeries, No. 957), Annex 2.Short name: WHO TRS No.957, Annex 2http://www.who.int/medicines/publications/44threport/en/9.WHO good manufacturing practicesfor sterilepharmaceutical products. WHO Expert Committee on Specifications for Pharmaceutical Preparationsrtyifth ReportGeneva, World Health Organization, 2011 (WHO Technical Report Series, No. 961), Ann

ex6.Short name: WHOTRS No.961, Annex 6http://whqlibdoc.who.int/trs/WHO_TRS_961_en.pdf?ua=110.WHO guidelines on transfer of technology in pharmaceutical manufacturing WHO Expert Committee on Specifications for Pharmaceutical Preparations. Fortyfth Report neva, World Health Organization, 2011 (WHO Technical Report Series, No1), Annex 7.Short name: WHO TRS No. 961, Annex 7http://whqlibdoc.who.int/trs/WHO_TRS_961_eng.pdf?u11.Model guidance for the storage and transport of timeand temperaturesensitie pharmaceutical productsWHO Expert Committee on Specifications for Pharmaceutical Preparations. Forifth ReportGen, World Health Organization, 2011 (WHOTechnical Report Series, No. 961), Annex 9. Short name:WHO TRS No.961, Annexhttp://whqlibdoc.who.int/trs/WHO_TRS_961_eng.pdf?ua=112.Generalguidelines forthe establishment maintenanceand distribution of chemical reference substances. WHO Expert Committee on Specificatons for Pharmaceutical Preparations. Fortyirst ReportGenevaWorld Health Organization2007 (WHO Technical Report Series,No.943) Annex 3. ort name: WHTRS No. 943Annex 3http://hqlibdoc.who.int/trs/WHO_TRS_943_eng.pdf?ua=113.WHO good practices for pharmaceutical microbiologylaboratories. WHO Expert Committee on Specifications for Pharmaceutical Preparations. Fortyifth Reportneva, World Health Organization, 2011 WHOTehnical Report Series, No.961), Annex 2.Short name: WHO TRS No.961, Annex 2http://whqlibdoc.who.int/trs/WHO_TRS_961_eng.pdf?ua=114.WHOguidelines on quality risk managementpert Committee on Specifications foPharmaceutical Preparations. Fortyeventh ReportGeneva, World Health Organization,2013 (WHO Technical Report Series,No. 981), Annex 2. Short name: WHO TRS No.981, Annex http://www.who.int/medicines/areas/quality_safety/quality_assurance/expert_committee/trs_981/en/15WHO guidelines on variation to a prequalified product. WHO Expert Committee on Speciications for Pharmaceutical Preparations. Fortyeventh ReportGeneva, World Health Organization, 2013Technical ReportSeries, No. 981), Annex 3. Short name: WHO TRS No.981, Annex 3http://www.who.int/medicines/areas/quality_safety/quality_assurance/expert_committee/trs_981/en/ PPIA 1211VA ITZERLAND EL CENTRAL AX CENTRAL +417913111WWWWHOINT Hetero L

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Annex 10.Short name: WHO Multisource guidance orHO TRS No.996,nex 10http://www.who.int/medicines/publcations/pharmprep/WHO_TRS_996_annex10.pdf22. Stability testing ofactive pharmaceutical ingredientsandfinished pharmaceutical products. WHOExpert Committee on Specifications for Pharmaceutical Preparations. Fiftyecond Report Geneva, World ealth Oganization, 2018 (WHO Technical Report Series, No. 1010), Annex 10. Short name: WHO TRS No.1010, Annex 10http://www.who.int/medicines/publications/pharmprep/WHO_TS_996_annex10.pdf23. Production of water for injection by means other than distillation. WHO ExpertCommittee onSpecifications for Pharmaceutical Preparations. Fiftyrth ReportGeneva, World HealthOrganization,2020 (WHO Technical Report Series. 1025), Annex 3.Short name: WHO TRS No.1025, Annex 3https://www.who.int/publicationsdetail/97892000182 PPIA 1211VA ITZERLAND EL CENTRAL AX CENTRAL +417913111WWWWHOINT Hetero Labs Ltd, Unit 5Telangana, Ind27 August and5 September 2020This inspection reporthe property of the WHContact: prequalinspection@who.intPage of 24. Good chromatography practice. WHO Expert Committeeon Specifictions for PharmaceuticalPreparations. Fiftyrth Report. Geneva, World Health Organization, 2020 (O TechnicalReport Series, No. 1025),Annex 4.Short name: WHO TRS No.1025, Annex 4https://www.who.int/publicationdetail/9789200018225. Points to consider for manufacturers and inspectors: environmental aspects of manufacturing for the revention of antimicrobial resistance. O ExpertCommittee on Specifications for Pharaceutical Preparations. FiftyReport. Geneva, World Health Organization, 2020 (WHO Technical Report Series, No. 1025),Annex 6.Shortname: WHO TRS No1025, Annexhttps://ww.who.int/publicationsdetail/9789200018226. WHO guidance ongood practices for desk assessment ofcompliance with good manufacturingpractices, good laboratory practices andgood clinical practices formedicalproducts regulatory decisionspert Committee on Specifications for Pharmaceutical Preparations. Fisecond Report. Geneva, World Health Organization,2018 (WHO Technical Report Series,No. 1010), Annex 9. Shortname: WHO TRS 1010, Annex 9https://www.who.int/medicines/areas/quality_safety/quality_assurance/TRS1010annex9.pdf?