Food and Beverages, Bio-Pharmaceutical Validation
Fruits & Vegetables cold chain validation
Meat cold chain validation
Fish and Seafood cold chain validation
Dairy products cold chain validation
beverages cold chain validation
Pharmaceutical cold chain validation
bio tech cold chain validation
vaccines cold chain validation
blood products cold chain validation
Clinical trails cold chain validation
Packaging cold chain validation
Packaging Development cold chain validation
Supply Chain cold chain validation
Program Manager cold chain validation
Quality cold chain validation
Transportation cold chain validation
Cold Chain validation
Compliance cold chain validation
Regulatory Affairs cold chain validation
Process Development cold chain validation
Clinical Operations cold chain validation
Logistics cold chain validation
Pharmaceutical Operations cold chain validation
Commercial Supply cold chain validation
Clinical Supply cold chain validation
Scientist cold chain validation
Product Quality cold chain validation
Stability cold chain validation
CMC cold chain validation
Benefits & Demands of cold chain validation
1) Packing and cooling fresh food products,
2) Food processing (i.e. freezing of certain processed foods,
3) Cold storage (short or long term warehousing of chilled or frozen foods),
4) Distribution (cold transport and temporary warehousing under temperature controlled conditions),
5) Marketing (refrigerated or freezer storage and displays at wholesale markets, retail markets and foodservice operations) can be simple or complex, low
tech or high tech.
Benefits of cold chain validation
It creates consistent results that the company can rely on.
It helps earn trust of product to end-users.
It opens opportunities for powerful business marketing.
It can boost employees sense of professionalism.
It can create bigger money-savings.
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
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Documentation services Validation in pakistan ,
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Equipment validation,
Facilities Validation in pakistan ,
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Process Validation in pakistan ,
Analytical method Validation in pakistan ,
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Design qualification (DQ) ,
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Validation Services List
Clean Room validation Services in pakistan ,
HVAC validation Services in pakistan ,
AHU Validation Services in pakistan ,
Qualification validation Services in pakistan ,
Mep validation Services in pakistan ,
Heating ventilation and air conditioning validation Services in pakistan ,
Validation and qualification of HVAC system ,
Heating, ventilation and air conditioning Validation Services in pakistan ,
Validation, Qualification and Calibration ,
Validation tests for hvac system Services in pakistan ,,
Validation Qualification Services in pakistan ,
Qualification and Validation Services in pakistan ,
Compressed Air Validation Services in pakistan ,
Nitrogen Gas Testing or Validation Services in pakistan ,
Pure steam Quality test Validation Services in pakistan ,
Documentation services Validation Services in pakistan ,
Equipment validation Services in pakistan ,
Facilities validation Services in pakistan ,
HVAC system validation Services in pakistan ,
Cleaning validation Services in pakistan ,
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Data verification validation Services in pakistan ,
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Equipment Validation Services in pakistan ,
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Equipment validation Services in pakistan ,
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Design qualification (DQ) Services in pakistan ,
Component qualification (CQ) Services in pakistan ,
Installation qualification (IQ) Services in pakistan ,
Operational qualification (OQ) Services in pakistan ,
Performance qualification (PQ) Services in pakistan ,
Pharmaceutical Process Validation Services in pakistan ,
Prospective Validation Services in pakistan ,
Concurrent Validation Services in pakistan ,
Retrospective Validation Services in pakistan ,
Revalidation Periodic and After Change validation Services in pakistan ,
Compressed Air Validation Services in pakistan ,
HVAC Validation Services in pakistan ,
Clean Room Validation Services in pakistan ,
PLC Validation Services in pakistan ,
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