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 ...

EQUIPMENT VALIDATION
 
 
 
Equipment Validation
 
  • Equipment Validation comprises a series of qualifications, such as Design, Installation, Operational, and Performance Qualification, that provide a high degree of assurance of the consistent, expected functioning of a piece equipment.
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  • Design Qualification (DQ).
  • Installation Qualification (IQ).
  • Operational Qualification (OQ).
  • Performance Qualification (P1Q).
  • Process Qualification (P2Q).
  •  
    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.
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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.
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    Validation List
     
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    Validation Services List
     
    Clean Room validation Services in ariyalur , HVAC validation Services in ariyalur , AHU Validation Services in ariyalur , Qualification validation Services in ariyalur , Mep validation Services in ariyalur , Heating ventilation and air conditioning validation Services in ariyalur , Validation and qualification of HVAC system , Heating, ventilation and air conditioning Validation Services in ariyalur , Validation, Qualification and Calibration , Validation tests for hvac system Services in ariyalur ,, Validation Qualification Services in ariyalur , Qualification and Validation Services in ariyalur , Compressed Air Validation Services in ariyalur , Nitrogen Gas Testing or Validation Services in ariyalur , Pure steam Quality test Validation Services in ariyalur , Documentation services Validation Services in ariyalur , Equipment validation Services in ariyalur , Facilities validation Services in ariyalur , HVAC system validation Services in ariyalur , Cleaning validation Services in ariyalur , process Validation Services in ariyalur , Analytical method validation Services in ariyalur , Computer system validation Services in ariyalur , Packaging validation Services in ariyalur , Cold chain validation Services in ariyalur , compressed Air Validation Services in ariyalur , HVAC Validation Services in ariyalur , Clean Room Validation Services in ariyalur , cold chain Validation Services in ariyalur , PLC Validation Services in ariyalur , Thermal Validation Services in ariyalur , Steam Quality Test Services in ariyalur , Design validation Services in ariyalur , Pharma Validation Services in ariyalur , Data verification validation Services in ariyalur , Clean Room AHU Area Validation Services in ariyalur , Calibration validation Services in ariyalur , Equipment Validation Services in ariyalur , Flow Calibration Validation Services in ariyalur , IAQ Indoor Air Quality Validation Services in ariyalur , Equipment validation Services in ariyalur , Facilities validation Services in ariyalur , HVAC system validation Services in ariyalur , Cleaning validation Services in ariyalur , Process Validation Services in ariyalur , Analytical method validation Services in ariyalur , Computer system validation Services in ariyalur , Design qualification (DQ) Services in ariyalur , Component qualification (CQ) Services in ariyalur , Installation qualification (IQ) Services in ariyalur , Operational qualification (OQ) Services in ariyalur , Performance qualification (PQ) Services in ariyalur , Pharmaceutical Process Validation Services in ariyalur , Prospective Validation Services in ariyalur , Concurrent Validation Services in ariyalur , Retrospective Validation Services in ariyalur , Revalidation Periodic and After Change validation Services in ariyalur , Compressed Air Validation Services in ariyalur , HVAC Validation Services in ariyalur , Clean Room Validation Services in ariyalur , PLC Validation Services in ariyalur , thermal validation Services in ariyalur , Steam Quality Test Services in ariyalur, design validation Services in ariyalur , pharmaceutical validation Services in ariyalur , data verification validation Services in ariyalur , Clean Room AHU Area Validation Services in ariyalur , Calibration validation Services in ariyalur , Equipment Validation Services in ariyalur , IAQ Indoor Air Quality Validation Services in ariyalur , IAQ Indoor Air Quality Validation Services in ariyalur ...
     
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