AN ISO/IEC - 17025 STANDARD - NABL ACCREDITATION LABORATORY / TRAINING AND CERTIFICATION - MECH - CIVIL - ELECTRICAL & IT COURSES / A to Z LABORATORY TESTING SERVICES / INSPECTION SERVICES / ALL ENGINEERING CONTRACTORS / MORE THAN 1500 SERVICES ...

PHARMACEUTICAL VALIDATION
 
 
 
Pharmaceutical Validation Services
 
  • Pharmaceutical and temperature maping services for for pharmaceutical equipments. The skilled technicians at our unit are well aware of the application demands of these instruments and ensure effective validation process. Some of the instruments for which we offer validation services.
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  • Auto Clave
  • Tray Dryer/Vaccume Ovans
  • Freezers
  • Stability Chamber
  • Tunnel
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    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
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    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.
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    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.
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    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.
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    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.
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    Validation List
     
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    Validation Services List
     
    Clean Room validation Services in new-delhi , HVAC validation Services in new-delhi , AHU Validation Services in new-delhi , Qualification validation Services in new-delhi , Mep validation Services in new-delhi , Heating ventilation and air conditioning validation Services in new-delhi , Validation and qualification of HVAC system , Heating, ventilation and air conditioning Validation Services in new-delhi , Validation, Qualification and Calibration , Validation tests for hvac system Services in new-delhi ,, Validation Qualification Services in new-delhi , Qualification and Validation Services in new-delhi , Compressed Air Validation Services in new-delhi , Nitrogen Gas Testing or Validation Services in new-delhi , Pure steam Quality test Validation Services in new-delhi , Documentation services Validation Services in new-delhi , Equipment validation Services in new-delhi , Facilities validation Services in new-delhi , HVAC system validation Services in new-delhi , Cleaning validation Services in new-delhi , process Validation Services in new-delhi , Analytical method validation Services in new-delhi , Computer system validation Services in new-delhi , Packaging validation Services in new-delhi , Cold chain validation Services in new-delhi , compressed Air Validation Services in new-delhi , HVAC Validation Services in new-delhi , Clean Room Validation Services in new-delhi , cold chain Validation Services in new-delhi , PLC Validation Services in new-delhi , Thermal Validation Services in new-delhi , Steam Quality Test Services in new-delhi , Design validation Services in new-delhi , Pharma Validation Services in new-delhi , Data verification validation Services in new-delhi , Clean Room AHU Area Validation Services in new-delhi , Calibration validation Services in new-delhi , Equipment Validation Services in new-delhi , Flow Calibration Validation Services in new-delhi , IAQ Indoor Air Quality Validation Services in new-delhi , Equipment validation Services in new-delhi , Facilities validation Services in new-delhi , HVAC system validation Services in new-delhi , Cleaning validation Services in new-delhi , Process Validation Services in new-delhi , Analytical method validation Services in new-delhi , Computer system validation Services in new-delhi , Design qualification (DQ) Services in new-delhi , Component qualification (CQ) Services in new-delhi , Installation qualification (IQ) Services in new-delhi , Operational qualification (OQ) Services in new-delhi , Performance qualification (PQ) Services in new-delhi , Pharmaceutical Process Validation Services in new-delhi , Prospective Validation Services in new-delhi , Concurrent Validation Services in new-delhi , Retrospective Validation Services in new-delhi , Revalidation Periodic and After Change validation Services in new-delhi , Compressed Air Validation Services in new-delhi , HVAC Validation Services in new-delhi , Clean Room Validation Services in new-delhi , PLC Validation Services in new-delhi , thermal validation Services in new-delhi , Steam Quality Test Services in new-delhi, design validation Services in new-delhi , pharmaceutical validation Services in new-delhi , data verification validation Services in new-delhi , Clean Room AHU Area Validation Services in new-delhi , Calibration validation Services in new-delhi , Equipment Validation Services in new-delhi , IAQ Indoor Air Quality Validation Services in new-delhi , IAQ Indoor Air Quality Validation Services in new-delhi ...
     
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| yanam | amritsar | barnala | bathinda | faridkot | fatehgarh sahib | fazilka | firozepur | hoshiarpur | jalandhar | kapurthala | ludhiana | mansa | moga | pathankot | patiala | rupnagar | sangrur | s.a.s nagar | shahid bhagat singh nagar | sri muktsar sahib | tarn taran | ajmer | alwar | banswara | baran | barmer | bharatpur | bhilwara | bikaner | bundi | chittorgarh | churu | dausa | dholpur | dungarpur | ganganagar | hanumangarh | jaipur | jaisalmer | jalore | jhalawar | jhunjhunu | jodhpur | karauli | kota | nagaur | pali | pratapgarh | rajsamand | sawai madhopur | sikar | sirohi | tonk | udaipur | east district | north district | south district | west district | adilabad | bhadradri kothagudem | hyderabad | jagitial | jangoan | jayashankar bhupalapally | jogulamba gadwal | kamareddy | karimnagar | khammam | kumuram bheem asifabad | mahabubabad | mahabubnagar | mancherial | medak | medchal malkajgiri | baghpat | mulugu | nagarkurnool | nalgonda | narayanpet | nirmal | nizamabad | 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mainpuri | mathura | mau | meerut | mirzapur | moradabad | muzaffarnagar | pilibhit | pratapgarh | prayagraj | rae bareli | rampur | saharanpur | sambhal | sant kabeer nagar | shahjahanpur | shamli | shravasti | siddharth nagar | sitapur | sonbhadra | sultanpur | unnao | varanasi | 24 paraganas north | 24 paraganas south | alipurduar | bankura | birbhum | coochbehar | darjeeling | dinajpur dakshin | dinajpur uttar | hooghly | howrah | jalpaiguri | jhargram | kalimpong | kolkata | maldah | medinipur east | medinipur west | murshidabad | nadia | paschim bardhaman | purba bardhaman | purulia ...
     
    list of our services following states
     
    andaman and nicobar islands | andhra pradesh | arunachal pradesh | assam | bihar | chandigarh | chhattisgarh | delhi | goa | gujarat | haryana | himachal pradesh | jnew-delhi 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
     
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