efrac PHARMA DIVISION Oferrd | PHARMA UNDER SINGLE ROOF EDWARD FOOD RESEARCH > & ANALYSIS CENTREefrac EXECUTIVE SUMMARY Location : Bares [20 mins om Kolkata Apo) (Only Lab in ast naa with advance equipment offer Food, Pharma and Envio testing services under single ook 27,000 sa. Lob area, offering mli-lb services under one rot 'n proximity to Phorma hubs (Sikkim / Guwahati] ond other clusters sch os Te plantation, Soo Port for aquaculture ot. Serving cients ocrss 7 regional centers which operate a sles & marketing ond sompling outs © Te-up with ogists companies (wih convited delivery te for domestic and interatonal pick-ups (n UAE, ME are Europe) ot the doorseps of clint - improves client enicing ond overall uraround ime Range of Services Ofered under Single Rootefrac Y Drugs & Cosmetics Cte S% Voretaron fat mes Singapore Pe, Kolkata Based Company fe ¥ Environment ‘Our team is devoted to provide ¥ Packoging Materials you bata safer, accurate eating fciiy to fecte ¥ Come ‘excellence in your business Steams —— eee cere hea ACCREDITATIONS 8 v4. Notional and Intemational lina ‘APPROVALS, Regulatory Approvle oon USDA Registered & Inspected Fociity | 9 edly Uith Bonboy Sock change Le ¥ > 50Conmesiios § 5000s ta Tro2s 017 Scope 2 Elcioey 2 Susy Tegete taboraeres ED feted a 1 Qik in ed Te) fifth Manpower ¥ 250% Manpower hae ry cue 160 Se Lob econsord | 4g Of Con a A 20 kms from NSCBI Airport, 3 Kolkota, Head Office F Analfical Fciiy ¥ 14 Gost Approved Signatories_ REGULATORY APPROVALS = cucu '> Notional Reference Laboratory (NRI for Government of Inia Cerio '> ISO 17025:2017, 180 17043:2010 180 9000:2015 & 150 £45001:2018 Standards x=» | Ministry of Environment & Forest & & Climate Change (MOEFCC) Wo lon Cot Board (PED, © Ministry of Health & Family Welfare (MOHFW) Hoy Cre & ey Pt © Ministry of Agricultural & Formers Welfare (MOAFW) 2...efrac ~ UR JOURNEY Obteined Accreditations From whee Started ‘Analyicol Services for Gos Testing USFDA Ragisation 1S USFDA Inspecon Inouguration of eaieeDiarel Obtcined NABL Obtained Sect ol Heath remneie Sorresszo17 Accwdicers From Cord Piet Neco theres Accreditation ‘© State Drug Authority |# Storted Specialized see Steed AmacalSwieskr Sp ers ered Cy Fost Err feet eel FSSA Oheion, FeaPeonertoreffering ones ose Neder Comuicion 18 GMO Anas tl Employees and Sit9 a eae i z e& manpower 8 wr lp OUR STRENGTHSefrac INSTRUMENT QUALIFICATIONS In the OG, tests ore performed on the citical orameters ofthe sytem / process, These are ‘svaly the independent ond / or meonipulated Y Compare user requirements with vorbles associoted withthe systom / equipment suppliers specications Alltets’ dota ond mecsurements must be eee er sts bean lr he ret eeemeeer CE peed lectern! CHANGE \ CONTROL = The system / equipment and is This phase ets the ability of the proces to perform components are installed comecll os per ‘over long periods ol ie within tolerance doomed a nce ‘accept is Colibation of maior equipment, occestory equipment, and/or uses should be performed in this step os wel PQ is performed onthe monufockring process oF 9 whole. Individual components ofthe syst ore not tested individuallyBRS aN tn a) ‘a wa Handover of Kis to Semple Drop Point of Ciy Genaratn of AVE Recep of Samples @— ‘tar Chasing f 1 Connsctnty to EFRAC Lab ot Kolkata ees ise = ‘Sample Condition ya + Sane kup ered Comecy Songer o Fe pee ae eee ate Rage ee, fea eee eee je. 1 Thormol Contoled Shipments or Porthaba Produce Live Tracking of Somplar Sole & Deccoted Tonspr fo LabpNP aaa Receipt of Somples technical Feasibility ‘kor Chacking of Semple Quantity ‘neat & Somele ‘Wok Order “Foctng > + Feprovel for Semple © > “Tomparatre Recisraton “Sample Condition @ GB; oe Releve Report tothe to a Results Entry, Review of ‘he Client Spocitcaion & Result Method, Calelations & “rend Analisis Sobmission of Rec in LIM Lge) eS * Registration of Somples ©--—9-~~* Ganeation of Unique through itegrotod LIMS Regisuation Number with Decoding & Barcoding sf. _. Dierbuton of & om ‘Samples to LabsOUR VALUES > act wih aoe hight standard of itegeay > Wa bab efor vlire eation > We sone quaiy & precon > Vivo lets & cuter scat incu cas > We beteving in leading by example > Scieca it uF NAB scene acumen our passon OUR ASPIRATION Te esabsh he Brand EFRAC os the glob leader ofthe Analyze and R&D sanices WHY WE ARE HERE 2 To devote cur sonics to improve ho ualy ond ssfety Sandrda ol ood incur coun end ‘enhance nc ol inthe global fod rode. > To connect EFRAC espera all ogee rom farm fo fork ta enere safety of food wile ‘eating, biggest epporunties for our ‘employes ond greet shraholder value. efrac WHAT WE BELIEVE TO OFFER Customer Focus 1 continuously sive to achive the heights of ccelence in mooing cwsonere expecorone regarding procienay asin, by foci on 2 Qualy comments and confident 2 Siole-ofstho-on analy! techriques and movie slo fa cen's need > Cost laciv sees, accurate and precise tet rents of oustanding quality ‘Team Spitit here of EFRAC we work oF a team dadicotd 10 provide bes axpenence of proisonc ening lo out Prtnrs, In oder to achive that we alway sick 2 Employing Ha wih ousting qualiy ond ererence 2 Condcing raining program fo sa tetra best of them,; efrac ANALYTICAL SERVICES ‘A) THERAPEUTIC & ESSENTIAL ORUGS Dy WarER ©, Rave Moteral/ingreients ‘0. Raw Water/Potable Water Aa Pharmacia Ingacants (ATS) Purified Water Y ingens ingredients or Expert «Water or Injection ». Veterinary Droge 4. Woter for Hoemodiolyse Finished Produets (Formulations) ‘2, Woter System Validations 4. Surgical Dressings | PACKAGING MATERIAL 8) AYURVEDIC DRUGS ‘. Plastic Container (Drum) (Raw Materials 3: Gloss Botte Ra ant Natori or Harb «Blood Bog % soimal Products 4. Corrugated Box Sere et tri v. Ftd le alo ¢ a Fecal ©) COSMETICS 18 Akwnien Fell Ran Metrics Y Finished Prostets SPECIALIZED SERVICES ‘9. Stbiliy/Shlf ie Studios b Edractable & Leachable Studios Anabel Method Development & Validetion {4 Method Optimaation and Veriicaion €¢ Microbiological Vaidations {Antibiotics Asay 6. Forced Degredetion Studies h. Cleaning VaidationMODERN & AYUSH DRUGS The Pharmaceutical Industry vse 0 vary large Vary of Row mtr and large Aroy of Ingresints involedino the Manulacring fo Single roduc Is ohen dic, not impossble fora Pharmaceutical Manufacturer to hoe nsbowseTesing Facies ond Capobitie fore he Ingredients ond Produc, FRACS Pham Tesing Division offers a Complete Solution fr Teng of Pharmaceutical Raw Materials incuding Pharmaceutical Drag Subsloncs, nerds, Expense Pharmaceucole and relied Indurtes require Commitment for GLP cGMP & SringertQuolty Sytem, Robust Dat neg Compliance which EFRAC hos dnatoed ver he Years hugh Comprehsie Setup for Tasting Drage tus enauing Quel & Reis as > hres Toing ve Faron Brg Teng > Surgical Dressing / Medial Device Tsing nw > Veterinary Drugs Tesingefrac INGREDIENT TESTING SRIEES Assay (Chamieal and Microbiological) Nikogenfsimation| Y,Baceral Endotoxin Tet (BET) Specie Optical Rtoion Boling Pot/Ronge ¥ Face Sue Daten Melting Peint/Range fac See Dart Clarity and Color of Solution ¥ Polymorphism 1 Congealing Temperature/Range Residual Solvents ond Orgnic Volatile Distillation range Impurities er he ¥ Stan ten iced te Fane Cageen vet tara s roa sce 7 Soin oot (Do on teeticton by FTIR, Chemical Anais le, Vico Yimercr aceasta Y Tens {iia Guentamoy Dacha Microbiol Lint Tt AT MSs Manele 1 LCMSMS [GGG] ¥ GC. IO) Y-GC- HEAD SPACE, ECD, MS) Y GCS ih Phammacpea [MS (GQ) ¥ HPLC FAD, PDA, ELS, RD} YAS lone, GTA VGA] ICP European Pharmocopsia (OFS Y/IERWS ¥ TOC Aras Y LV Vibe Sectophorter ¥ Brockild Indien Phrmacopeia Vacomer V CHNS&.0 Aner V FR V ln Chomatogonh Y KaFiher Japanese Pharmacopela ‘stator TGA Y SC ¥ Pore Sae Aah Untied Stes PhormacopeiaFORMULATION DRUG TESTING efrac zy (Cheicalond Miroinogical Conon ive ngrdiont tev Endtonin Tas (EN) ¥ Dapsiion ol he Emit Doce Being Pci Range Mating Pi/Ronge ¥ Dacipon ¥ Clty ond Color of Seton ¥ ittegrtion Txt ¥ Congesing Tererareange ¥ Disoion Sd ¥ Dislaicn forge ¥ Osmoary Elmer Ac % Fitty Tsing % featomar Ply ¥ Uniommay of Con Ufo of Dosage Uns ¥ Fay Acid Compaston aay Matos (vont) by AAS, CP OFS, RMS ¥ entcatonby FER, Charical Arle Resid Soles and Organic Vaile Inputs Sars Esluaon eee oe cee vse Y Limit Tet (Quanta Esraton) ee ¥ icrobal Limit Test IMET) Nivogen Etinatin 7 sea ioe aint, Perens ire ee oa mo gene ioe ee Aa es eee ee oe eas ¥GCHSIMS (20) ¥ Fre eee ‘HPLC FLD, PDA, ELSD, RID) lon Chromatograph ssiepresbueianinen! AAS — (Flome, GTA, VGA) ¥ Karl-Fisher Autotirator United States Pharmacopsia eee as YO foal Force Soe AnatSURGICAL DRESSINGS/ MEDICAL DEVICES efrac ERIIGES ¥ Absrbency Y beity ¥ Alii ¥ Forign Fibres ¥ Colouring Maer ¥ Ghar Soluble Subwances Lots on Dying 1 Fucrscance Foreign Matar Scouring Last Pacant GSI ¥_ UY Miso Spacrophotomeor Digit Planar ¥ Digtl Rerocorsatee Flame Photometar ¥ Hot Air Oven Y Mulla Fnac pH & Conductvy Meter Ralrgeroted Contiuge ota Evopertor ¥ Tena Taser ¥.Compresion ester Burin Seng Tester ¥ Colriet Y Auto Troe Kel Fiche Titer Y Stove Tester ¥ UV Chamber ¥ Vocuum Deer ¥ sey Fran Opel Whaener¥ Surace Active Substances ldeniction Pera Tet Tosi Test, Length & Wish Tsods par dn ¥ Woler Soluble Substances ¥ Wight in g/mn2 (65M) Taney ¥ Brtah Phormocopeia ¥ Drugs ane Courts Act & Rules ¥ European Phormacopeia ~ Indion Pharmacopoia Indion Standard 5) ¥ 80 astm United States Phamacopeiaefrac eftac VETERINARY DRUG TESTING Assay [Cheical and Moblogic) Hear, Mae (Qn) by AA, ICP, ICP MS Bacterial Endotonin Test (ET) enticaon by FER % BotingPon/Ronge Y mpures and Relsted Substonces ¥ Nealing PointRonge Y, Umi Tats (Guntoie Esinein) Y, Clarity and Calor Solaion rial rt et] %, Congealng Temperotira/Ronge % Nien Estimation % Daailaion Range Y, Specie Opel Rotaon ¥ Element Anais Particle See Dstibuon Y,Enantomerie Pty Y Pelymersiam Fon Acid Componton °,Reelol Solvents ond Orgone Volo Impurias Y, Content of Ave Inge! ,Senscey Evaluation Y,Deposton of he Ersited Dose ¥ Silty % Dercrition Y Steroid Assy % Disitagration Test ¥ Sulphur Donde Etmation ¥ Disclton Std YM ¥, Ormoloriy TGR Anais ¥ Fabliy Testing SC Analyse Y, Unerrty f Confen/Unforniy of Dosage Unis Parla Site Ara ¥ PhanclinVscne ond Anne BISHIINE ¥ LC-MS M5 |QOG) ¥ GC. FID) ¥ GC: HEAD SPACE, ECD, MS) GC-MS MS [GGG] ¥_HPLC FLO, POA, USD, RIO} ¥ AAS-Flame, GTA, VGA) ¥ ICP OES IGPMS TOC Arla 7 UV ible Spcophotoneter ¥ ‘brooktald Vicomgtar ¥CHNS & © Analaer ¥ FTIR Y lon Chernatoggaph + Kar-feher otttor TGA ¥" DSC Coulometr ¥ Fiaiiy Teter ¥”Hordeas Ter *” Diego Tet Appar * Diselton Tes Apparatus 7 Pensromeer © BRP Apporotvs ” Potniomate¥ Pete Sis Ander CGoeEs Seth Promacopeia Indian Pharmacopsin «Unt States Fharmocopeis _Y European Phamacopeo Japanese Phomacopsiaee aes ile ¥ Joponess Phammacopeia Y Unied Sites Phommacapeia Y Beth Phomacsesia| Exropean Pharacopaa Indien Fhamacopsio Bureau ofan Standort (8) asim vs Physical Pores [Dscripin, Appearance, Fane) Sensory Evalaton Y Adhesion Tet ¥ Blah art Y op ot Tet Y Sertch Tost Seeing Pent ¥ Foaming Power ¥ Alcchal Cantet ¥ Avclable Foti fon ¥ Cake Tiogyalc Cloud Temparatre Post ¥ Colou/Clriy ¥ Consserey titre ond Volote Mater Dye Ingrdiens Free Carbonated & Cauti Akl efrac Y Gheeral Conant ¥ Hecwy Metal (Quontatie) Y iit Tats ¥ tate nicub in Meshal Boling Wiote/Cold Wiser Y teling Ronge/Poit ¥ Nonvolale Alcohol Soluble Mass Y Price Sze of Unisperzad Pigments ¥ Synths Detergent 1 Test fo fear om Boi Aid « Tharal toby Y Tota Fat Substnce/Mate ¥ Micosty Y tierobielogial Testing + Teor specie Organi (TST LCS, Patel Se Anaya ¥ GC.|FID/ECD/TCDIMS)_—¥ WWWistle WLC [FLD/ FDAY ELSD/ RID)’ Spacrophotomeer ¥ ARS. (flame, GTA, VGA) Brookilé Viscometer YICPOESICP MS. Y Polrimeter ¥IC-CD/AD/WY Y Colerimeer Y Pay of Test Apparat eee Sevteh Test Apparatus Tromete Ais Rfacomatr Vern DryerPHARMACEUTICAL WATER TESTING ‘Walt plas Cant Rn the Prodan of Pharmaceuicl, a widely weed ob 2 Row Matera, ingrdins& Sovens in Proce, Formsion & Monaco Feapectufed fain Rgreciccs & Piched Produce, Te et SHI ‘Quahy Regrets apy fo Peawaceical Wet, bob oxo Prd Compan ‘nd intnasol Corsumpton, Pro chanical ard Melisa usly Con re eer er Moniocving i occonlonce wth CUP en or prosed lam EFRAC hos cy lr Comte Anal Raw We oabie os), Pua ds cx pr der Plreororoael el otam len ponies Seve or Vs Som east GH Aga ro he Roa Tesigs in Woh EFRAC itr exon Ws fegultery Faquromens 01 SERN, W086, I ‘ole ong ef Diy rane ond Dios PCB n Noter| efrac ERGs Fy Chemical arama ¥, OrgonlepicPranates Y rene % seine ed Cations Hoo Mae ¥ OCr8 SIC ¥, Organic Iowan Diinocons Y Hilo Aco: Acts Y pa GSE RoC HENS ICM GC: D/ECOMTCDIMS) ¥-GCMS/PaTMS WUC LD, POA, ESO, RID) vem 18S Plone, GTA. VGA cP OE8 vicems vic-comDaN ¥, UV Mile Specophotomesr TOC Analaar ¥ CANS BO Anolper vce ¥ Tol Orgone Carbon (TOC) esis (spr EU, FDA, ‘WHO, EPA) ¥ isn and Front ¥ Al Mobili Toss As per £, FDA, YIM, EP ¥ asoocve Compounds (iho ‘on Bata Ener EISEN ¥ BitahPhomacopeio ¥ Exropaan Phamocopia Indian Pharmacopeia Japenese Phommoeopaa Y Unite Stes Frormacopas WHO Guideline ¥ 15 10500 2012, ¥ 4251-1967 v 20H ¥USFDA BAM ¥ Counc Diacive 98/69/8C v usersefrac MICROBIOLOGICAL VALIDATIONS Y Detection of Pathogens ¥ Nicrbicogia Method Valdotion Y hati Mizobial aor. Y cri Li Tet LT) ¥ Enumeration of Spologe Mice-Flora Residual An Microbial Substances ¥ Bact! Enteotonins Y Bactril Endotosin Te (Al) Y Seity Testing Y Nyce Bioburden Analisi, TAM, TYMIC ¥ Nicrobiclogical Monitoring of Indoor ie Y Aol Microbial Efzacy of Medicl Devicesitrs Y reserve coop ¥ DisilectonEeacy Y Potency Asay Y ROC Ts, SC Test, Y Surgical Desings & Medical Denes Y Microbiological Aaroye ¥ Microbiclogical Asay of Viti ¥ Membrane Fivaton Mashod (ll Bactrl and Fungal groupe ¥ Environmental Mentoring Tess ¥ Rodec or Setting Pets Coun ¥ tropa Viable Air Sampler Plates Count ond isentiicabon| ¥ Grom Sting Y \dentiieation of Boca Species ¥ entiation of Fungo Species ¥ Tota Coe E, cl Wile Heterotopic Pte Count ¥ Nadia Growth Promotion Media Fan Tosing ¥ Growth Promotion Tet Quaticine ¥ Grown Promotion Tet Guentatve Y Haothore Products 8 Disifaconis ¥ Ercluaton of Anincrbial Propeie of Difarent Heathcors Products 0s pe Cuslomer Suppted Protecla/ASTM Mathes Y MIC Tsing Y Neutalition Ting ex par ASTM 1054-02 Y Antieobial EfacvenessTstog of Personne Hand Wether Saniier Y Germicidal vee ¥ Phonic Oiknletanis os pr iS 1061 Y Real Wer Ceaficiont (RWC) Y Sal Conan Bnicalos Spore Sip Inmanefrac MICROBIOLOGICAL VALIDATIONS ¥ Auto Der ¥ Ral Tne PCR ¥ Binocular Microscope ¥ Full Automated Avtocloves Coupled with Chan Wer Actviy Mater Recorders & Auto Cele Programming Feature ~ Laborotory Rkigeators wth Temp Montoring and Recording Fectres ¥ Cold Room for Sample Storage Y fideo! Wioker Coaicont RNC) v aoe incubmon tron ae 7 Stthvecocas Aureus Coficunt (SAC) Ct lente Peee eeel yeoreee eeee rena Coupled Win 2TCPR Aud Tal Sofware sa Bt Y EISA / Microplate Reader Y Balance nteotte with Printers Y laminar Air Flow Hoods Y Blo. Safty Cabinet Clans AT Y Spore Sip Immersion Y Bitih Pharmocopsio Y Unie Sots Phoeacops vast ¥ European Pharmacopeo WHO Guides US FDA 84M Methods ledion Pheracopeia USEPA Gudaines ¥ 'S0 Gvidelinesefrac ldeniiaion (Macroscopic / Orgonlapi / Sensony Microscopic, Chana) ¥ eat Valve ¥ aid sla ah Y de Vale Aduharaon with Modem Drogt/Drg Residues Alois (Guatative and Quoniatve) leah! Contant & Alcohol Sle Exact ¥ Anal of Mineral Raw Materia Matae ¥ dasy of Morker Compounds Boing Pinange Y Chromatographie Fingerprinting Stcies by TIC, HPLC, GC, GC-MS, LC-MS/MS. , Congeling Rangeela! ¥ Eeervelve Y Ear Solbla Exractvas Fired Oi Estimation ¥ Fluorescence Analyse Y Foreign Maer ¥, Hecwy Mtoe (Quoltobve ond Quontatie) Y Hrd Vole losin Yue Y it ts ¥ loss on Drying Mlare Contant tens on tniion Y ebing PontRonge Y (Mirai ii Tat nd Tse or Specie Organisms Pesci Residues Pomdeted Het Anais ¥ Protein Estimation ¥ Exel Ol Esimation ¥ Raat Inder & Relative Desy Fat Ac Profiling ond Compostion Y Amino eid Prong ¥ SugorEsimation Top 8 Bulk density Test for Mineral i Tojo Ash, ASA and Sulphate Ash ‘eto Phenalc Compounds Toto Selide etal Tanning ¥ Uneoponifiable Mater Y Vecosty ¥ Volatile Essenta! Oi Content Wier Content Wie Sale Ach Wie Slefrac MS ¥-LCMS MS (G09) ¥ FIR GC-FID) ¥ lon Chematograth GC. HEAD SPACE, ECD, MS) Kari-FiharAstrator GCS MS (@GQ) VGA Y HPLC FLD, POA, E180, RID] OSC YAS Flame, GTA, YA) Y Digi Plorimeter ¥ IcPOES: ¥ FeabilyTorer ICP Y Herdnes Tester ¥, TOC Anahaor Disintgraton Tee apparatus UV Mable Specrophotometer¥ Distoluon Test apporake ¥ Brood Vicometer Y Pencrometer ¥ Coulometer BPI Apparat Y-CHNS 8 Analer Y Potetometer Enis sya ramocopcea fide ¥ Food Chemical Codex FCC) Indian Phammacopasia Siddna Phamocopesa finda. ¥” Unted Stole Phomocopsia Bath Phormacopea Y United tte: Phormacopeia Indian Standard 5) Y Una Pharmacoposia of dia ¥ WHO GuidelinesFxtacabls and inachabas are Grovp of Compounds ‘hat can be of Potent Rik and may inuee @ Seraut Freel ea pees peer eee ah Generics and. Formulation End Product for both Domeste & Expo Marte When Clements ond Compounds loch ito Pests, rom Packaging or anulacuring Conditions they can render thar unt ‘ond even dangers for us, leachables anal ene Substances which migecte ‘rom Polen, Mile or Gloss Maral into the patent and are pial 2 subs! of hose wanted in the Esroeabes “Anais. This ype of Analisi requied when thre i ovis that harmful Substoncas Imay hove laachad ito 0 Liquid Produ, such os Eye Drops, Hom Contains or Packaging The Msestnen) of Ectorcbles and Leachables in Bo-Phormaceucal Products is an important sep in Drug Product Development. Recesing Eauipmert, 0: ee eel eater eee Fen Veto for chemical Contant Etrocables Anasie ienties Cotegoristion ond Guomilcaton of Substances which could gotetally rmayate rom Polar, Metalic or Glaze Material nto efrac EXTRACTABLES AND LEACHABLES ¥ HPLC-UN DAD YHS-GC, HS-GOMS ¥ GC IO, ECD, FID-NF, GC-MS ¥ GCTEA Nirosomines ¥ ICP-OES, ICP-MS, AAS, FTIR TGA OSC Pore Sue Anahoer the Consumers body through any of the Medicines consumed by them during the process of Westen. incur Monomers on Falmer Addives auch ot Anions, Posters, Sabie, Dyes, Matol Catala her Harmlal Chere wich ray potentially migrate ino the Product under Storage Condins ‘Applicable Guidelines & Regulator Requirements - USP <1663>, USP <1684>, EMA. CPMP / GWP/ 4359/03, CH ~ Q3A (82), FGRS [sor 07, Soph 06), USED Guidance for ley (1992, 2002)