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