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DESIGN VALIDATION
 
 
 
DESIGN VERIFICATION AND VALIDATION
 
  • validation activities should begin after design transfer to production specifications, design validation planning can start as soon as user needs and intended uses are specified. Typical validation activities include:
  •  
  • Analysis of relevant scientific literature
  • • Comparisons to similar devices on the market
  • • Usability testing (e.g., effectiveness of user interfaces and labeling)
  • • Simulated use of the device by users
  • • Clinical trials (e.g., actual use of device per IDE regulations).
  • When performing design validation, it is important to specify:
  • • Environment and operating conditions
  • • Types of users (abilities, skills, and knowledge)
  • • Type of use (actual or simulated)
  • • Use of initial production units (or their equivalent).
  •  
    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
  • Isolator Validation
  • Biosafety, LAF Validation
  •  
    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:
  •  
    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.
  •  
    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 | jmoga 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
     
    alipur | chanakya puri | civil lines | defence colony | delhi cantonment | dwarka | gandhi nagar | hauz khas | kalkaji | kanjhawala | kapeshera | karawal nagar | karol bagh | kotwali | mayur vihar | mehrauli | model town | najafgarh | narela | patel nagar | preet vihar | punjabi bagh | rajouri garden | rohini | saket | saraswati vihar | sarita vihar | seelam pur | seema puri | shahdara | vasant vihar | vivek vihar | yamuna vihar | adampur | alewa | ambala | ambala cantonment | assandh | ateli | babain st | badhra | badkhal | badli | badshahpur st | bahadurgarh | bahal st | bahin st | ballabgarh | ballah st | balsamand st | bapoli | barara | barwala | barwala st | bass | bawal | bawani khera | beri | bhattukalan st | bhiwani | bhuna st | bilaspur | bondkalan st | chhachhrauli | dabwali | dadri | dahina st | dayalpur st | dhand st | dharuhera st | dhauj st | ellenabad | faridabad | farrukhnagar | fatehabad | fatehpur pundri | ferozepur jhirka | ganaur | gaunchi st | gharaunda | gohana | goriwala st | guhla | gurgaon | hansi | harsaru st | hassanpur st | hathin | hisar | hodal | indri | ismailabad st | israna | jagadhri | jakhal st | jhajjar | jind | julana | kadipur st | kaithal | kalanaur | kalanwali | kalayat | kalka | kanina | karnal | khanpur st | kharkhoda | kheri jalab st | khizrabad st | kosli | kulan st | ladwa | lakhan majra st | loharu | maham | mahendragarh | manesar | manethi st | matenhail | matlauda | mohna st | morni st | mulana st | nagina st | nahar st | nangal chawdhary | naraingarh | narnaul | narnaund | narwana | nathusari chopta | nigdu st | nilokheri | nising st | nuh | palhawas st | palwal | panchkula | panipat | pataudi | pehowa | pillukhera st | punahana | radaur | raipur rani | rai st | rajaund st | rania | ratia | rewari | rohtak | sadhaura st | safidon | saha st | salhawas st | samalkha | sampla | saraswati nagar st | satnali st | shahbad | shahzadpur st | sirsa | siwani | siwan st | sohna | sonipat | taoru | thanesar | tigaon st | tohana | tosham | uchana | uklana st | wazirabad st | abohar | ahmedgarh | ajnala | amloh | amritsar -i | amritsar- ii | anandpur sahib | baba bakala | bagha purana | balachaur | banga | barnala | bassi pathana | batala | bathinda | bhawanigarh | bhikhiwind | bhulath | budhlada | chamkaur sahib | dasua | dera baba nanak | dera bassi | dharamkot | dhar kalan | dhuri | dinanagar | dirba | dudhan sadhan | faridkot | fatehgarh sahib | fazilka | firozpur | garhshankar | gidderbaha | gurdaspur | guruharsahai | hoshiarpur | jagraon | jaitu | jalalabad | jalandhar - i | jalandhar - ii | kalanaur | kapurthala | khadur sahib | khamanon | khanna | kharar | kotakpura | lehra | ludhiana (east) | ludhiana (west) | majitha | malerkotla | malout | mamdot | mansa | maur | moga | moonak | morinda | mukerian | muktsar | nabha | nakodar | nangal | nawanshahr | nihal singhwala | pathankot | patiala | patran | patti | payal | phagwara | phillaur | raikot | rajpura | rampura phul | rup nagar | samana | samrala | sangrur | sardulgarh | sas nagar (mohali) | shahkot | sultanpur lodhi | sunam | talwandi sabo | tapa | tarn taran | zira...
     
    list of our services following districts
     
    alampur amb | ani | arki | aut | baddi | bagachnogi | baijnath | baldwara | balh | bali chowki | bangana | banjar | baroh | barsar | bhadrota | bhalai | bharari | bharmour | bharwain | bhattiyat | bhawarna | bhoranj | bhota | bhuntar | bilaspur sadar | birhu kalan | chachyot | chadiyar | chamba | chaupal | chhatri | chirgaon | churah | dadahu | dadasiba | dalhousie | dareeni | darlaghat | deha | dehar | dera gopipur | dhami | dharmpur | dharmsala | dharwala | dhatwal | dhira | dodra kwar | dulahar | fatehpur | gagret | galore | gangath | ghanari | ghumarwin | hamirpur | hangrang | harchakian | haripur | haripurdhar | haroli | holi | indora | ispur | jaisinghpur | jalog | jangla | jaswan | jawalamukhi | jawali | jhanduta | jogindarnagar | jol | jubbal | junga | kakira | kalol | kalpa | kamrau | kandaghat | kangoo | kangra | karsog | kasauli | katoula | khundian | kotgarh | kotkhai | kotla | kotli | krishangarh | kullu | kumarsain | kunihar | kupvi | lad bharol | lagru | lahul | majheen | makridi | mamlig | manali | mandap | mandi | mehatpur | morang | multhan | nadaun | nagrota bagwan | nagrota surian | nahan | naina devi | nalagarh | namhol | nankhari | narag | nerwa | nichar | nihri | nirmand | nither | nohra | nurpur | pachhad | padhar | pajhota | palampur | panchrukhi | pangi | pangna | panjehra | paonta sahib | poo | pragpur | pukhri | rajgarh | rakkar | rampur | ramshahr | renuka | rewalsar | rohru | ronhat | sainj | saluni | sandhol | sangla | sarahan | sarawati nagar | sarkaghat | shahpur | shalai | shimla ( rural ) | shimla (urban) | sihunta | solan | spiti | sulah | sundarnagar | sunni | taklech | tapri | tauni devi bamson | theog | thunag | thural | tihra | tikar | tikken | tira sujanpur | udaipur | una | ajas | akhnoor | aloosa | anantnag | anantnag east | aripal | arnas | arnia | assar | atholi (paddar) | awantipora | bahu | balakote | bandipora | bani | banihal | baramulla | barbugh | bari brahamana | basantgarh | basohli | batote | beerwah | beri pattan | bhaderwah | bhagwah | bhalessa | bhalla | bhalwal | bharath bagla | bhomag | bijbehara | billawar | bishnah | bk pora | boniyar | bounjwah | budgam | chadoora | channapora | charar- e- shrief | chassana | chenani | chhatroo | chilly pingal | chiralla | chitragam | chowki choura | dachhan | dangarpora | danghiwacha | dansal | darhal | devsar | d h pora | dinga amb | doda | dooru | drabshalla | drugmulla | eidgah | frisal | ganderbal | ghagwal | gool | gund | gundna | gurez | hajin | handwara | haveli | hermain | hiranagar | jmoga | jmoga north | jmoga south | jmoga west | jourian | kahara | kakapora | kalakote | kangan | karnah | kashtigarh | kathua | katra | kawarhama | keegam | keller | keran | khag | khansahib | khanyar | kharah balli | khari | khawas | khoie | khour | kishtwar | kokernag | koteranka | kralpora | kreeri | kulgam | kunzar | kupwara | lalpora | langate | lar | larnoo | laroka | latti | lohai malhar | lolab | machail | machil | magam | mahanpur | mahore | maira mandrian | majalta | mandal | mandi | manjakote | mankote | marh | marheen | marmat | marwah | mendhar | mohalla | moungri | mughalmaidan | nagri | nagrota | nagseni | narbal | nowshera | pahalgam | pahloo | pampore | panchari | panthachowk | pargwal | pattan | phigsoo | pogal paristan | pouni | pulwama | qaimoh | qaziabad | qazigund | qila darhal | rafiabad | rajgarh | rajouri | rajpora | rajpura | ramban | ramgarh | ramhal | ramkote | ramnagar | ranbir singh pura | reasi | sallar | samba | shahbad bala | shahoora | shangus | shopian | siot | sonawari | sopore | srigufwara | srinagar central | srinagar (north) | srinagar (south) | suchetgarh | sundarbani | surankote | tangmarg | taryath | thakrakote | thana mandi | thathri | thuroo | tral | trehgam | tulail | tullamulla khirbhawani | udhampur | uri | vijaypur | wagoora | wakoora | warwan | watergam | yaripora | zachaldara | zainapora | zaingeer | 277 chandigarh | adibadri | almora | bageshwar | bagwalipokhar | bajpur | balganga | bangapani | barakot | barnigad | basukedar | berinag | betalghat | bhagwanpur | bhanoli | bhatwari | bhikiasain | bironkhal | chakisain | chakrata | chamoli | champawat | chaubatta khal | chaukhutiya | chinyali saur | dehradun | devalthal | devprayag | dewal | dhanaulti | dharchula | dhari | dhaulchhina | dhauntari | dhoomakot | dhyari | didihat | doiwala | dugnakuri | dunda | dwarahat | gadarpur | gairsain | gaja | ganai gangoli | gangolihat | garud | ghaat | ghansali | haldwani | hardwar | jainti | jakhani dhar | jakhanikhal | jakholi | jalali | jaspur | jilasu | joshimath | joshiyara | kafligair | kaladhungi | kalsi | kanalichhina | kanda | kandisaur | kapkot | karnaprayag | kashipur | khatima | kichha | kirtinagar | kosya kutauli | kotdwara | laksar | laldhang | lalkuan | lamgada | lansdowne | lohaghat | machhor | madannegi | manch | mori | munsiari | nainbag | nainital | nanakmatta | nandprayag | narayanbagar | narendra nagar | narsan | okhalkanda | pankhu | pati | pauri | pawkidevi | pithoragarh | pokhari | poornagiri | pratapnagar | pulla gumdesh | puraula | rajgarhi | ramgarh | ramnagar | ranikhet | rikhanikhal | rishikesh | roorkee | rudraprayag | rudrapur | sankari | satpuli | shama | sitarganj | someshwar | srinagar | sult | syalde | tehri | tejam | thailisain | thal | tharali | tyuni | ukhimath | vikas nagar | yamkeshwar | drass | kargil | khalsi | leh | nubra | sanku | shaker chiktan | zanskar...