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.
  •  
  • Auto Clave
  • Tray Dryer/Vaccume Ovans
  • Freezers
  • Stability Chamber
  • Tunnel
  •  
    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:
  •  
    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
     
    Clean Room Validation Validation in chile , HVAC Validation Validation in chile , AHU Validation Validation in chile , Qualification Validation in chile , Mep Validation in chile , Heating ventilation and air conditioning Validation in chile , Validation and qualification of HVAC system , Heating, ventilation and air conditioning Validation in chile , Validation, Qualification and Calibration , Validation tests for hvac system , Validation Qualification Services , Qualification and Validation in chile , Compressed Air Validation in chile , Nitrogen Gas Testing or Validation in chile , Pure steam Quality test Validation in chile , Documentation services Validation in chile , Equipment Validation in chile , Facilities Validation in chile , HVAC system Validation in chile , Cleaning Validation in chile , process Validation in chile , Analytical method Validation in chile , Computer system Validation in chile , Packaging Validation in chile , Cold chain Validation in chile , compressed Air Validation in chile , HVAC Validation in chile , Clean Room Validation in chile , cold chain Validation in chile , PLC Validation in chile , Thermal Validation in chile , Steam Quality Test , Design Validation in chile , Pharma Validation in chile , Data verification Validation in chile , Clean Room AHU Area Validation in chile , Calibration Validation in chile , Equipment Validation in chile , Flow Calibration Validation in chile , IAQ Indoor Air Quality Validation in chile , Equipment validation, Facilities Validation in chile , HVAC system Validation in chile , Cleaning Validation in chile , Process Validation in chile , Analytical method Validation in chile , Computer system Validation in chile , Design qualification (DQ) , Component qualification (CQ) , Installation qualification (IQ) , Operational qualification (OQ) , Performance qualification (PQ) , Pharmaceutical Process Validation in chile , Prospective Validation in chile , Concurrent Validation in chile , Retrospective Validation in chile , Revalidation Periodic and After Change Validation in chile , Compressed Air Validation in chile , HVAC Validation in chile , Clean Room Validation in chile , PLC Validation in chile , thermal Validation in chile , Steam Quality Test , design Validation in chile , pharmaceutical Validation in chile , data verification Validation in chile , Clean Room AHU Area Validation in chile , Calibration Validation in chile , Equipment Validation in chile , IAQ Indoor Air Quality Validation in chile , IAQ Indoor Air Quality Validation in chile ...
     
    Validation Services List
     
    Clean Room validation Services in chile , HVAC validation Services in chile , AHU Validation Services in chile , Qualification validation Services in chile , Mep validation Services in chile , Heating ventilation and air conditioning validation Services in chile , Validation and qualification of HVAC system , Heating, ventilation and air conditioning Validation Services in chile , Validation, Qualification and Calibration , Validation tests for hvac system Services in chile ,, Validation Qualification Services in chile , Qualification and Validation Services in chile , Compressed Air Validation Services in chile , Nitrogen Gas Testing or Validation Services in chile , Pure steam Quality test Validation Services in chile , Documentation services Validation Services in chile , Equipment validation Services in chile , Facilities validation Services in chile , HVAC system validation Services in chile , Cleaning validation Services in chile , process Validation Services in chile , Analytical method validation Services in chile , Computer system validation Services in chile , Packaging validation Services in chile , Cold chain validation Services in chile , compressed Air Validation Services in chile , HVAC Validation Services in chile , Clean Room Validation Services in chile , cold chain Validation Services in chile , PLC Validation Services in chile , Thermal Validation Services in chile , Steam Quality Test Services in chile , Design validation Services in chile , Pharma Validation Services in chile , Data verification validation Services in chile , Clean Room AHU Area Validation Services in chile , Calibration validation Services in chile , Equipment Validation Services in chile , Flow Calibration Validation Services in chile , IAQ Indoor Air Quality Validation Services in chile , Equipment validation Services in chile , Facilities validation Services in chile , HVAC system validation Services in chile , Cleaning validation Services in chile , Process Validation Services in chile , Analytical method validation Services in chile , Computer system validation Services in chile , Design qualification (DQ) Services in chile , Component qualification (CQ) Services in chile , Installation qualification (IQ) Services in chile , Operational qualification (OQ) Services in chile , Performance qualification (PQ) Services in chile , Pharmaceutical Process Validation Services in chile , Prospective Validation Services in chile , Concurrent Validation Services in chile , Retrospective Validation Services in chile , Revalidation Periodic and After Change validation Services in chile , Compressed Air Validation Services in chile , HVAC Validation Services in chile , Clean Room Validation Services in chile , PLC Validation Services in chile , thermal validation Services in chile , Steam Quality Test Services in chile, design validation Services in chile , pharmaceutical validation Services in chile , data verification validation Services in chile , Clean Room AHU Area Validation Services in chile , Calibration validation Services in chile , Equipment Validation Services in chile , IAQ Indoor Air Quality Validation Services in chile , IAQ Indoor Air Quality Validation Services in chile ...
     
    list of our services following cities
     
    antofagasta | arica | calama | copiapó | coronel and lota | curicó | greater chillán | greater concepción | greater iquique | greater la serena | greater quillota | greater rancagua | greater santiago | greater talca | greater temuco | greater valparaíso | los ángeles | osorno | puerto montt and puerto varas conurbation | punta arenas | san antonio | valdivia, antofagasta | arica y parinacota | antofagasta | atacama | biobío | maule | ñuble | biobío | tarapacá | coquimbo | valparaíso | o'higgins | metropolitana de santiago | maule | araucanía | valparaíso | biobío | los lagos | los lagos | magallanes | valparaíso | los ríos, arica and parinacota region | tarapacá | tarapacá, tarapacá, antofagasta | atacama, coquimbo, valparaíso | santiago metropolitan region | santiago metropolitan, o'higgins | maule | biobío, araucanía | los ríos | los lagos | aysén | magallanes, arica | iquique | alto hospicio | pozo almonte | antofagasta | calama | tocopilla | chuquicamata | taltal | estación zaldívar | mejillones | maría elena | copiapó | vallenar | caldera | chañaral | el salvador | tierra amarilla | diego de almagro | huasco | coquimbo | la serena | ovalle | illapel | vicuña | salamanca | los vilos | andacollo | combarbalá | el palqui | monte patria | viña del mar | valparaíso | quilpué | villa alemana | san antonio | quillota | los andes | san felipe | la calera | limache | concón | quintero | la ligua | llay-llay | cartagena | casablanca | cabildo | placilla de peñuelas | la cruz | olmué | el melón | nogales | el quisco | hijuelas | san esteban | putaendo | catemu | santa maría | las ventanas | algarrobo | rinconada | calle larga | santo domingo | el tabo | puente alto | maipú | la florida | las condes | san bernardo | peñalolén | santiago | pudahuel | la pintana | el bosque | ñuñoa | cerro navia | recoleta | renca | conchalí | la granja | estación central | quilicura | providencia | pedro aguirre cerda | lo espejo | macul | lo prado | quinta normal | san joaquín | la reina | san ramón | la cisterna | vitacura | san miguel | huechuraba | lo barnechea | cerrillos | independencia | peñaflor | colina | melipilla | talagante | buin | padre hurtado | el monte | paine | curacaví | lampa | isla de maipo | la islita | bajos de san agustín | hospital | alto jahuel | san josé de maipo | tiltil | pirque | rancagua | san fernando | rengo | machalí | graneros | san vicente de tagua tagua | santa cruz | chimbarongo | mostazal | pichilemu | requínoa | lo miranda | doñihue | peumo | nancagua | las cabras | quinta de tilcoco | gultro | codegua | palmilla | talca | curicó | linares | constitución | cauquenes | molina | parral | san javier | san clemente | teno | longaví | villa alegre | hualañé | concepción | talcahuano | chillán | los ángeles | coronel | hualpén | chiguayante | san pedro de la paz | lota | penco | tomé | curanilahue | san carlos | mulchén | nacimiento | lebu | cañete | chillán viejo | arauco | la laja | hualqui | los álamos | cabrero | bulnes | coelemu | yungay | yumbel | quirihue | quillón | coihueco | santa juana | santa bárbara | huépil | monte águila | san rosendo | temuco | angol | padre las casas | villarrica | victoria | lautaro | nueva imperial | collipulli | loncoche | traiguén | pucón | pitrufquén | curacautín | carahue | gorbea | purén | cunco | labranza | freire | renaico | valdivia | la unión | río bueno | panguipulli | paillaco | los lagos | lanco | mariquina | futrono | puerto montt | osorno | castro | ancud | puerto varas | quellón | calbuco | purranque | llanquihue | frutillar | río negro | fresia | los muermos | coyhaique | puerto aysén | punta arenas | puerto natales ....