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VALIDATION SERVICES
 
 
 
What is validation?
 
  • Validation is a process of establishing documentary evidence demonstrating that a procedure, process, or activity carried out in production or testing maintains the desired level of compliance at all stages.
  • In Pharma Industry it is very important apart from final testing and compliance of product with standard that the process adapted to produce itself must assure that process will consistently produce the expected results
  • Here the desired results are established in terms of specifications for out come of the process. Qualification of systems and equipment is therefore a part of process of validation.
  • It is a requirement of food and drug, pharmaceutical regulating agencies like FDA's good manufacturing practices guidelines. Since a wide variety of procedures, processes, and activities need to be validated, the field of validation is divided into a number of subsections including the following:
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    Validation Services
     
  • Clean Room and HVAC/AHU Validation/Qualification
  • Compressed Air/Nitrogen Gas Testing or Validation
  • Pure steam Quality test
  • Documentation services
  • Equipment validation
  • Facilities validation
  • HVAC system validation
  • Cleaning validation
  • Process Validation
  • Analytical method validation
  • Computer system validation
  • Packaging validation
  • Cold chain validation
  • Compressed Air Validation
  • HVAC Validation
  • Clean Room Validation
  • cold chain Validation
  • PLC Validation
  • Thermal Validation
  • Steam Quality Test
  • Design validation services
  • Pharma Validation Services
  • Data-verification validation services
  • Clean Room AHU Area Validation Services
  • Calibration validation
  • Equipment Validation Services
  • Flow Calibration
  • IAQ - Indoor Air Quality
  •  
    The Validation Process:
     
  • The validation scope, boundaries and responsibilities for each process or groups of similar processes or similar equipment's must be documented and approved in a validation plan. These documents, terms and references for the protocol authors are for use in setting the scope of their protocols. It must be based on a Validation Risk Assessment (VRA) to ensure that the scope of validation being authorised is appropriate for the complexity and importance of the equipment or process under validation. Within the references given in the VP the protocol authors must ensure that all aspects of the process or equipment under qualification; that may affect the efficacy, quality and or records of the product are properly qualified. Qualification includes the following steps:
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    Design qualification (DQ)
     
  • Demonstrates that the proposed design (or the existing design for an off-the-shelf item) will satisfy all the requirements that are defined and detailed in the User Requirements Specification (URS). Satisfactory execution of the DQ is a mandatory requirement before construction (or procurement) of the new design can be authorised.
  •  
    Installation qualification (IQ)
     
  • Demonstrates that the process or equipment meets all specifications, is installed correctly, and all required components and documentation needed for continued operation are installed and in place.
  •  
    Operational qualification (OQ)
     
  • Demonstrates that all facets of the process or equipment are operating correctly.
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    Performance qualification (PQ)
     
  • Demonstrates that the process or equipment performs as intended in a consistent manner over time.
  •  
    Component qualification (CQ)
     
  • This term refers to the manufacturing of auxiliary components to ensure that they are manufactured to the correct design criteria. This could include packaging components such as folding cartons, shipping cases, labels or even phase change material. All of these components must have some type of random inspection to ensure that the third party manufacturer's process is consistently producing components that are used in the world of GMP at drug or biologic manufacturer.
  •  
    Validation List
     
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    Validation Services List
     
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    andaman and nicobar islands | andhra pradesh | arunachal pradesh | assam | bihar | chandigarh | chhattisgarh | delhi | goa | gujarat | haryana | himachal pradesh | jkatihar and kashmir | jharkhand | karnataka | kerala | ladakh | lakshadweep | madhya pradesh | maharashtra | manipur | meghalaya | mizoram | nagaland | odisha | puducherry | punjab | rajasthan | sikkim | tamil nadu | telangana | the dadra and nagar haveli and daman and diu | tripura | uttarakhand | uttar pradesh | west bengal ...
     
    list of our services following districts
     
    adhartal | agar | ajaigarh | alirajpur | alot | amanganj | amarpatan | amarwara | ambah | amla | anjad | anuppur | aron | ashoknagar | ashta | ater | athner | awantipur badodiya | babai | bada malhera | badarwas | badgaon dhasan | badi | badnagar | badnawar | badod | badoda | badoni | badwara | bagli | bahadurpur | bahari | bahoriband | baihar | bairad | bajag | bajna | balaghat | baldeogarh | bamor | bamori | banda | bandhogarh | bankhedi | baraily | barghat | barhi | barwaha | barwani | basoda | batiyagarh | beerpur | begamganj | beohari | berasia | betul | betul nagar | bhagwanpura | bhainsdehi | bhander | bhanpura | bhavra | bhicholihapsi | bhikangaon | bhimpur | bhind | bhind nagar | bhitarwar | biaora | bichhiya | bichhua | bijawar | bilaspur | bina | birsa | birsinghpur | budar | budni | burhanpur | burhanpur nagar | buxwaha | chachaura | chand | chanderi | chandia | chandla | chaurai | chhapara | chhatarpur | chhatarpur nagar | chhindwara | chhindwara nagar | chicholi | chinour | chitrangi | churhat | city center | dahi | daloda | damoh | danyantinagar | datia | datia nagar | deori | deori | deosar | depalpur | devendranagar | dewas | dewas nagar | dhanora | dhar | dharampuri | dhimarkheda | dindori | dolariya | gadarwara | gairatganj | gandhwani | garhakota | garoth | gaurihar | ghansaur | ghatigaon | ghatiya | ghoda dongri | ghughari | ghuwara | gird | gogaon | gohad | goharganj | gohparu | gopadbanas | gorakhpur | gormi | gotegaon | gulabganj | gulana | guna | guna nagar | gunnor | gurh | gyaraspur | handiya | hanumana | harda | harrai | harsud | hatod | hatpiplya | hatta | hoshangabad | hoshangabad nagar | huzur | huzur | huzur nagar | ichhawar | indergarh | indore | isagarh | itarsi | jabalpur | jabera | jaisinagar | jaisinghnagar | jaithari | jaitpur | jamai | jaora | jatara | jawa | jawad | jawar | jhabua | jharda | jhiranya | jiran | jirapur | jobat | joura | kailaras | kalapipal | kanadiya | kannod | karahal | kareli | karera | karkeli | kasrawad | katangi | kathiwara | katni nagar | keolari | kesli | khacharod | khairlanji | khaknar | khalwa | khandwa | khandwa nagar | khaniyadhana | khargapur | khargone | khargone nagar | khategaon | khilchipur | khirkiya | khudel | khujner | khurai | kirnapur | kolar | kolaras | kotar | kothi | kothi mahal | kotma | kukshi | kumbhraj | kundam | kurai | kurwai | kusmi | lahar | lakhnadon | lalbarra | lanji | lateri | laundi | lidhora | mada | maharajpur | maheshwar | mahidpur | maihar | majhauli | majhgawan | majholi | makdon | maksoodangarh | malharganj | malhargarh | malthon | manasa | manawar | mandla | mandsaur | mandsaur nagar | mangawan | manpur | mau | mauganj | meghnagar | mehgaon | mhow | mihona | mohangarh | mohkhed | moman badodiya | morena | morena nagar | multai | mungaoli | murar | murwara or katni | nagda | nagod | naigarhi | nainpur | nai sarai | nalkheda | narayanganj | narsimhapur | narsinghgarh | narwar | nasrullaganj | nateran | neemuch | neemuch nagar | nepanagar | niwali | niwari | niwas | nowgong | nowrozabad | orchha | pachore | palera | pali | panagar | pandhana | pandhurna | panna | pansemal | parasia | paraswada | patan | patera | pathari | patharia | pati | pawai | petlawad | pichhore | pichhore or dabra | pipariya | piploda | piprai | pithampur | pohri | polaykala | porsa | prabhatpattan | prithvipur | punasa | pushparajgarh | raghogarh | raghurajnagar nagareey | rahatgarh | raipura | raipur - karchuliyan | raisen | rajgarh | rajnagar | rajpur | rama | ramnagar | rampura | rampur baghelan | rampur naikin | ranapur | ranjhi | rannod | ratlam | ratlam nagar | rau | rawti | rehatgaon | rehli | rehti | rithi | ron | sabalgarh | sagar | sagar nagar | saikheda | sailana | sanawad | sarai | sarangpur | sardarpur | satwas | sausar | sawer | segaon | sehore | sehore nagar | semaria | sendhwa | seondha | seoni | seoni-malwa | seoni nagar | shadhora | shahgarh | shahnagar | shahpur | shahpura | shahpura | shajapur | shamgarh | shamshabad | sheopur | shivpuri | shivpuri nagar | shujalpur | shyampur | sihawal | sihora | silwani | simariya | singoli | singrauli | singrauli nagar | sirali | sirmour | sironj | sitamau | sleemnbad | sohagpur | sohagpur | sondawa | sonkatch | sultanpur | susner | suthaliya | suwasara | tal | tamia | tansen | tarana | tendukheda | tendukheda | teonthar | thandla | thikri | tikamgarh | timarni | tirodi | tonk khurd | tyonda | udainagar | udaipura | ujjain | ujjain nagar | umreth | unchahara | varla | vidisha | vidisha nagar | vijaypur | vijayraghavgarh | waraseoni | abapura | abu road | ahore | ajmer | aklera | alwar | amber | amet | anandpuri | antah | anupgarh | arain | arnod | artuna | asind | asnawar | aspur | atru | badgaon | badnor | bagidora | bagora | bajju | bakani | balesar | bali | bamanwas | banera | bansur | banswara | baori | bap | bapini | baran | bari | bari sadri | barmer | baseri | bassi | baswa | bayana | baytoo | beawar | begun | behror | bhadesar | bhadra | bhaniyana | bharatpur | bhilwara | bhim | bhinay | bhindar | bhinmal | bhopalgarh | bhopalsagar | bhusawar | bichiwara | bidasar | bijoliya | bikaner | bilara | bonli | buhana | bundi | chaksu | chauth ka barwara | chhabra | chhatargarh | chhipabarod | chhoti sadri | chhoti sarwan | chikhali | chirawa | chitalwana | chittaurgarh | chohtan | chomu | churu | danta ramgarh | dausa | dechu | deeg | degana | delwara | deogarh | deoli | desuri | dhanaau | dhariawad | dhaulpur | dhod | dhorimanna | didwana | digod | dudu | dug | dungarpur | dungla | duni | fatehgarh | fatehpur | gadraroad | galiyakot | gangadtalai | ganganagar | gangapur | gangdhar | gangrar | ganoda | garhbor | garhi | gharsana | ghatol | gida | girwa | gogunda | govindgarh | gudha malani | hameergarh | hanumangarh | hindaun | hindoli | hurda | indragarh | jahazpur | jaipur | jaisalmer | jaitaran | jalor | jamwa ramgarh | jaswantpura | jayal | jhadol | jhalrapatan | jhunjhunun | jodhpur | jothari | kaman | kanod | kanwas | kapasan | karanpur | karauli | kareda | kathumar | kekri | keshoraipatan | khajuwala | khamnor | khandar | khanpur | kheenvsar | khendela | kherwara | khetri | kishanganj | kishangarh | kishangarh bas | kishangarh renwal | kolayat | kotkasim | kotkhawda | kotputli | kotra | kotri | kuchaman city | kumbhalgarh | kumher | kushalgarh | kuwaria | lachhmangarh | lachhmangarh | ladnu | ladpura | lalsot | lasadiya | lawan | lohawat | luni | lunkaransar | mahwa | makrana | malakhera | malarna doongar | malpura | malsisar | mandal | mandalgarh | mandawar | mandawar | mandrayal | mangrol | mania | manohar thana | marwar junction | masalpur | masuda | mauzamabad | mavli | merta | mundwa | nadbai | nadoti | nagar | nagaur | nainwa | nangal rajawatan | narayanpur | nasirabad | nathdwara | nawa | nawalgarh | neem-ka-thana | neemrana | nimbahera | niwai | nohar | nokha | osian | pachpadra | pachpahar | padampur | pahari | pali | parbatsar | pavta | peepalkhoont | peeplu | peesangan | phagi | phalodi | phooliya kalan | phulera (hq.sambhar) | pilibanga | pindwara | pipalda | pipar shahar | pirawa | pokaran | poogal | pratapgarh | pushkar | rahuwas | railmagra | raipur | raipur | raipur | raisinghnagar | rajakhera | rajgarh | rajgarh | rajsamand | ramganj mandi | ramgarh | ramgarh pachwara | ramgarh shekawati | ramsar | rani | raniwara | rashmi | ratangarh | ravla | rawatbhata | rawatsar | reni | reodar | rishabhdeo | riyan badi | rohat | roopangarh | rupbas | sabla | sadulshahar | sagwara | sahara | sajjangarh | salumbar | samdari | sanchore | sanganer | sangaria | sangod | sapotra | sarada | sardarshahar | sarmathura | sarwar | sawai madhopur | sawar | sayla | sedwa | semari | sepau | shahbad | shahpura | shahpura | shekhala | sheo | sheoganj | shergarh | sidhmukh | sikar | sikrai | sikri | simalwara | sindhari | sirohi | siwana | sojat | sridungargarh | sri madhopur | sujangarh | sumerpur | sunel | surajgarh | suratgarh | suroth | talera | tantoli | taranagar | tatgarh | tehla | thanagazi | tibi | tijara | tinwari | todabhim | todaraisingh | tonk | uchhain | udaipurwati | uniara | vallabhnagar | vijainagar | vijaynagar | viratnagar | wazeerpur | weir .......
     
    list of our services following districts
     
    agra | ajitmal | akbarpur | akbarpur | aliganj | allahabad | allapur | amariya | amethi | amritpur | amroha | anupshahr | aonla | atarra | atrauli | aurai | auraiya | azamgarh | baberu | badlapur | baghpat | bah | baheri | bahraich | bairia | bakshi ka talab | baldirai | ballia | balrampur | banda | bangarmau | bansdih | bansgaon | bansi | bara | baraut | bareilly | barhaj | basti | behat | belthara road | bhadohi | bhanpur | bharthana | bhatpar rani | bhinga | bhiti | bhogaon | bhognipur | bidhuna | bighapur | bijnor | bikapur | bilari | bilaspur | bilgram | bilhaur | bilsi | bindki | bisalpur | bisauli | biswan | budaun | budhana | bulandshahr | burhanpur | campierganj | chail | chakarnagar | chakia | chandauli | chandausi | chandpur | charkhari | chauri chaura | chhata | chhibramau | chunar | colonelganj | dadri | dalmau | dataganj | debai | deoband | deoria | derapur | dhampur | dhanaura | dhaulana | dhaurahara | domariyaganj | dudhi | etah | etawah | etmadpur | faizabad | faridpur | farrukhabad | fatehabad | fatehpur | fatehpur | firozabad | gabhana | garautha | garhmukteshwar | gauriganj | gautam buddha nagar | ghanghata | ghatampur | ghaziabad | ghazipur | ghiror | ghorawal | ghosi | gola | gola gokaran nath | gonda | gorakhpur | govardhan | gunnaur | gyanpur | haidergarh | hamirpur | handia | hapur | hardoi | harraiya | hasanganj | hasanpur | haseran | hata | hathras | iglas | ikauna | itwa | jaisinghpur | jakhania | jalalabad | jalalpur | jalaun | jalesar | jamunaha | jansath | jasrana | jaswantnagar | jaunpur | jewar | jhansi | kadipur | kaimganj | kairana | kaiserganj | kalan | kalinagar | kalpi | kannauj | kanpur | kanth | kaptanganj | karchhana | karhal | karwi | kasganj | kasimabad | kasya | kerakat | khadda | khaga | khair | khajni | khalilabad | khatauli | khekada | kheragarh | khurja | kiraoli | kishni | koil | konch | koraon | kulpahar | kunda | kurawali | laharpur | lakhimpur | lalganj | lalganj | lalganj | lalganj | lalitpur | lambhua | loni | machhlishahr | madawara | madhogarh | madhuban | maharajganj | maharajganj | mahasi | mahavan | mahmudabad | mahoba | maholi | mahroni | mainpuri | maitha | malihabad | manikpur | manjhanpur | mankapur | mariahu | marihan | martinganj | mat | mathura | mau | maudaha | maunath bhanjan | mauranipur | mawana | meerganj | meerut | mehdawal | mehnagar | meja | mihinpurwa motipur | milak | milkipur | mirzapur | misrikh | mitauli | modinagar | mohammadabad | mohammdi | mohanlalganj | moradabad | moth | mugalsarai | muhammadabad gohna | musafirkhana | muzaffarnagar | nagina | najibabad | nakur | nanpara | naraini | narwal | naugarh | naugarh | naugawan sadat | nautanwa | nawabganj | nawabganj | nichlaul | nighasan | nizamabad | orai | padrauna | pailani | pali | palia | patiyali | patti | payagpur | pharenda | phulpur | phulpur | pilibhit | pindra | powayan | pratapgarh | puranpur | purwa | rae bareli | rajapur | rajatalab | ramnagar | rampur | rampur maniharan | ramsanehighat | raniganj | rasra | rasulabad | rath | robertsganj | rudauli | rudhauli | rudrapur | sadabad | sadar | sadar | safipur | sagri | saharanpur | sahaswan | sahawar | sahjanwa | saidpur | saifai | sakaldiha | salempur | salon | sambhal | sandila | sardhana | sarila | sarojani nagar | sasni | sawayajpur | sevrai | shahabad | shahabad | shahganj | shahjahanpur | shamli | shikarpur | shikohabad | shohratgarh | siana | sidhauli | sikanderpur | sikandra | sikandrabad | sikandra rao | sirathu | sirauli gauspur | sirsaganj | sitapur | sohawal | soraon | suar | sultanpur | tahrauli | takha | talbehat | tamkuhi raj | tanda | tanda | tarabganj | thakurdwara | tilhar | tiloi | tirwa | tulsipur | tundla | un | unchahar | unnao | utraula | zamania | adapur | adhaura | agiaon | akbarpur | akorhi gola | alamnagar | alauli | alinagar | amarpur | amas | amdabad | amnour | amour | andar | andhratharhi | araria | areraj | ariari | arrah | arwal | asarganj | asthawan | athmalgola | atri | aurai | aurangabad | azamnagar | babubarhi | bachhwara | bagaha | bahadurganj | bahadurpur | baheri | baikunthpur | bairgania | bairia | baisa | baisi | bajpatti | bakhri | bakhtiarpur | balia | balrampur | bandra | baniapur | banjaria | banka | bankatwa | banke bazar | banma itahri | banmankhi | barachatti | barahat | barahiya | barari | barauli | barauni | barbigha | barh | barhampur | barhara | barhara | barharia | barhat | bariarpur | barsoi | barun | baruraj (motipur) | basantpur | basantpur | basopatti | bathnaha | bausi | begusarai | behea | belaganj | belchhi | beldaur | belhar | belsand | ben | benipatti | benipur | bettiah | bhabua | bhagwanpur | bhagwanpur | bhagwanpur | bhagwanpur hat | bhargama | bhawanipur | bhitaha | bhorey | bibhutpur | bidupur | bihar | bihariganj | bihpur | bihta | bijaipur | bikram | bikramganj | bind | biraul | birpur | bisfi | bithan | bochaha | bodh gaya | bokhara | buxar | chainpur | chakai | chakia(pipra) | chakki | chanan | chanan | chand | chandi | chanpatia | chapra | charaut | charpokhari | chaugain | chausa | chausa | chautham | chehra kalan | chenari | cheria bariarpur | chewara | chhatapur | chhorahi | chiraia | dagarua | dalsinghsarai | dandari | dandkhora | daniawan | darauli | daraundha | darbhanga | dariapur | daudnagar | dawath | dehri | deo | desri | dhaka | dhamdaha | dhanarua | dharhara | dholi (moraul) | dhuraiya | dighalbank | dighwara | dinapur-cum-khagaul | dinara | dobhi | dulhin bazar | dumaria | dumra | dumraon | dumri katsari | durgawati | ekangarsarai | ekma | falka | fatehpur | fatwah | forbesganj | gaighat | gamharia | garhani | garhpura | garkha | gaunaha | gaya town c.d.block | ghailarh | ghanshyampur | ghat kusumbha | ghoghardiha | ghorasahan | ghoshi | ghoswari | gidhaur | giriak | gobindpur | gogri | goh | gopalganj | gopalpur | gora bauram | goradih | goraul | goriakothi | guraru | gurua | guthani | gwalpara | hajipur | halsi | hanumannagar | harlakhi | harnaut | harsidhi | hasanganj | hasanpur | hasanpura | haspura | hathua | hayaghat | hilsa | hisua | hulasganj | hussainganj | imamganj | ishupur | islamnagar aliganj | islampur | ismailpur | itarhi | jagdishpur | jagdishpur | jainagar | jalalgarh | jalalpur | jale | jamalpur | jamui | jandaha | jehanabad | jhajha | jhanjharpur | jogapatti | jokihat | kadwa | kahalgaon | kahara | kako | kaler | kaluahi | kalyanpur | kalyanpur | kanti | karai parsurai | karakat | kargahar | karpi | kasba | kashi chak | katihar | katiya | katoria | katra | katrisarai | kawakol | keotiranway | kesaria | kesath | khagaria | khaira | khajauli | khanpur | kharagpur | kharik | khizirsarai | khudabandpur | khusrupur | kiratpur | kishanganj | kishanganj | kishanpur | kochadhamin | kochas | koilwar | konch | korha | kotwa | krityanand nagar | kuchaikote | kudra | kumarkhand | kurhani | kursakatta | kursela | kurtha | kusheshwar asthan | kusheshwar asthan purbi | kutumba | ladania | lahladpur | lakhisarai | lakhnaur | lakri nabiganj | lakshmipur | lalganj | laukaha | laukahi | lauriya | madanpur | madhepur | madhepura | madhuban | madhubani | madhubani | madhwapur | maharajganj | mahishi | mahnar | mahua | mainatanr | mairwa | majhaulia | majorganj | maker | makhdumpur | maner | manigachhi | manihari | manjha | manjhi | manpur | mansahi | mansi | mansurchak | marauna | marhaura | marwan | masaurhi | mashrakh | matihani | mehsi | meskaur | minapur | modanganj | mohania | mohanpur | mohanpur | mohiuddinagar | mokameh | morwa | motihari | muhra | munger | murliganj | musahri | nabinagar | nagar nausa | nagra | nanpur | naokothi | narayanpur | nardiganj | narhat | narkatia | narkatiaganj | narpatganj | nasriganj | nathnagar | naubatpur | naugachhia | nauhatta | nauhatta | nautan | nautan | nawada | nawanagar | neem chak bathani | nirmali | nokha | noorsarai | nuaon | obra | pach deuri | pachrukhi | paharpur | pakribarawan | pakri dayal | palasi | paliganj | panapur | pandarak | pandaul | paraiya | parbalpur | parbatta | parihar | paroo | parsa | parsauni | patahi | patarghat | patepur | paterhi belsar | patna rural | patori | phenhara | phulidumar | phulparas | phulwari | phulwaria | pipariya | pipra | piprakothi | piprarhi | piprasi | piro | pirpainti | pothia | pranpur | pratapganj | punpun | pupri | puraini | purnahiya | purnia east | pusa | rafiganj | raghopur | raghopur | raghunathpur | rahui | raja pakar | rajauli | rajaun | rajgir | rajnagar | rajpur | rajpur | ramgarh | ramgarh chowk | ramgarhwa | ramnagar | rampur | rangra chowk | raniganj | ratni faridpur | raxaul | revelganj | riga | roh | rohtas | rosera | runisaidpur | rupauli | sabour | sahar | sahdai buzurg | sahebganj | sahebpur kamal | sakra | salkhua | samastipur | sameli | sampatchak | sandesh | sangrampur | sangrampur | sanjhauli | saraigarh bhaptiyahi | sarairanjan | saraiya | sarmera | sasaram | satar kataiya | saur bazar | shahkund | shahpur | shambhuganj | shamho akha kurha | shankarpur | sheikhpura | shekhopur sarai | sheohar | sheosagar | sherghati | shivaji nagar | sidhaw | sidhwalia | sikandra | sikta | sikti | silao | simri | simri bakhtiarpur | singheshwar | singhia | singhwara | sirdala | siswan | siwan | sonbarsa | sonbarsa | sonbhadra banshi suryapur | sonepur | sonhaula | sono | srinagar | sugauli | sultanganj | supaul | suppi | surajgarha | sursand | suryapura | tajpur | tan kuppa | taraiya | tarapur | tarari | tardih | tariani chowk | teghra | terhagachh | tetaria | tetiha bambor | thakrahan | thakurganj | tharthari | thawe | tikari | tilouthu | tribeniganj | turkaulia | uchkagaon | udwant nagar | ujiarpur | vaishali | vidyapati nagar | warisaliganj | warisnagar | wazirganj | ziradei...