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.
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:
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 burundi ,
HVAC Validation Validation in burundi ,
AHU Validation Validation in burundi ,
Qualification Validation in burundi ,
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Heating ventilation and air conditioning Validation in burundi ,
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Validation Qualification Services ,
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Compressed Air Validation in burundi ,
Nitrogen Gas Testing or Validation in burundi ,
Pure steam Quality test Validation in burundi ,
Documentation services Validation in burundi ,
Equipment Validation in burundi ,
Facilities Validation in burundi ,
HVAC system Validation in burundi ,
Cleaning Validation in burundi ,
process Validation in burundi ,
Analytical method Validation in burundi ,
Computer system Validation in burundi ,
Packaging Validation in burundi ,
Cold chain Validation in burundi ,
compressed Air Validation in burundi ,
HVAC Validation in burundi ,
Clean Room Validation in burundi ,
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PLC Validation in burundi ,
Thermal Validation in burundi ,
Steam Quality Test ,
Design Validation in burundi ,
Pharma Validation in burundi ,
Data verification Validation in burundi ,
Clean Room AHU Area Validation in burundi ,
Calibration Validation in burundi ,
Equipment Validation in burundi ,
Flow Calibration Validation in burundi ,
IAQ Indoor Air Quality Validation in burundi ,
Equipment validation,
Facilities Validation in burundi ,
HVAC system Validation in burundi ,
Cleaning Validation in burundi ,
Process Validation in burundi ,
Analytical method Validation in burundi ,
Computer system Validation in burundi ,
Design qualification (DQ) ,
Component qualification (CQ) ,
Installation qualification (IQ) ,
Operational qualification (OQ) ,
Performance qualification (PQ) ,
Pharmaceutical Process Validation in burundi ,
Prospective Validation in burundi ,
Concurrent Validation in burundi ,
Retrospective Validation in burundi ,
Revalidation Periodic and After Change Validation in burundi ,
Compressed Air Validation in burundi ,
HVAC Validation in burundi ,
Clean Room Validation in burundi ,
PLC Validation in burundi ,
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Steam Quality Test ,
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Clean Room AHU Area Validation in burundi ,
Calibration Validation in burundi ,
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IAQ Indoor Air Quality Validation in burundi ,
IAQ Indoor Air Quality Validation in burundi ...
Validation Services List
Clean Room validation Services in burundi ,
HVAC validation Services in burundi ,
AHU Validation Services in burundi ,
Qualification validation Services in burundi ,
Mep validation Services in burundi ,
Heating ventilation and air conditioning validation Services in burundi ,
Validation and qualification of HVAC system ,
Heating, ventilation and air conditioning Validation Services in burundi ,
Validation, Qualification and Calibration ,
Validation tests for hvac system Services in burundi ,,
Validation Qualification Services in burundi ,
Qualification and Validation Services in burundi ,
Compressed Air Validation Services in burundi ,
Nitrogen Gas Testing or Validation Services in burundi ,
Pure steam Quality test Validation Services in burundi ,
Documentation services Validation Services in burundi ,
Equipment validation Services in burundi ,
Facilities validation Services in burundi ,
HVAC system validation Services in burundi ,
Cleaning validation Services in burundi ,
process Validation Services in burundi ,
Analytical method validation Services in burundi ,
Computer system validation Services in burundi ,
Packaging validation Services in burundi ,
Cold chain validation Services in burundi ,
compressed Air Validation Services in burundi ,
HVAC Validation Services in burundi ,
Clean Room Validation Services in burundi ,
cold chain Validation Services in burundi ,
PLC Validation Services in burundi ,
Thermal Validation Services in burundi ,
Steam Quality Test Services in burundi ,
Design validation Services in burundi ,
Pharma Validation Services in burundi ,
Data verification validation Services in burundi ,
Clean Room AHU Area Validation Services in burundi ,
Calibration validation Services in burundi ,
Equipment Validation Services in burundi ,
Flow Calibration Validation Services in burundi ,
IAQ Indoor Air Quality Validation Services in burundi ,
Equipment validation Services in burundi ,
Facilities validation Services in burundi ,
HVAC system validation Services in burundi ,
Cleaning validation Services in burundi ,
Process Validation Services in burundi ,
Analytical method validation Services in burundi ,
Computer system validation Services in burundi ,
Design qualification (DQ) Services in burundi ,
Component qualification (CQ) Services in burundi ,
Installation qualification (IQ) Services in burundi ,
Operational qualification (OQ) Services in burundi ,
Performance qualification (PQ) Services in burundi ,
Pharmaceutical Process Validation Services in burundi ,
Prospective Validation Services in burundi ,
Concurrent Validation Services in burundi ,
Retrospective Validation Services in burundi ,
Revalidation Periodic and After Change validation Services in burundi ,
Compressed Air Validation Services in burundi ,
HVAC Validation Services in burundi ,
Clean Room Validation Services in burundi ,
PLC Validation Services in burundi ,
thermal validation Services in burundi ,
Steam Quality Test Services in burundi,
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data verification validation Services in burundi ,
Clean Room AHU Area Validation Services in burundi ,
Calibration validation Services in burundi ,
Equipment Validation Services in burundi ,
IAQ Indoor Air Quality Validation Services in burundi ,
IAQ Indoor Air Quality Validation Services in burundi ...
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