Validation – What is it

Validation – What is it

What is Validation?

Validation is documented evidence that a process/equipment/system/software/procedure complies with specifications, criteria and requirements which are defined in a pre-approved protocol and detailed in:

  • Specifications
  • Definitions
  • Quality aspects
  • Customer needs and expectations
  • Health authority and other regulatory requirements

Since the mid-20th century, control and traceability of products with pharmacological and/or medical treatment effects and/or have an impact on human/animal health conditions have become a focus of governmental health authorities and public awareness. FDA has developed standards and requirements to assure customer safety and health. These requirements are detailed in Title 21 of the FDA Code of Federal Regulations (CFR).

Subsequent to FDA and other world health authority decisions to increase product surveillance, the pharmaceutical, biotech and medical device industries created new verification and validation procedures to align with FDA and other authorities and patients expectations and requirements for improved product quality, safety and efficacy. These expectations include testing, documentation, process standardization, controls and methods for full traceability of each manufactured product, from the point of raw material receipt and acceptance, during production and through the entire supply chain.

Validation and qualification are general terms used to cover all efforts performed to attain the goal of approved and assured reliability, quality, safety and efficacy of pharmaceutical and medical products.


Why do we validate?

Validation demonstrates that a pharmaceutical/medical device or other medical product complies with all quality, safety and efficacy requirements. The validation process is documented evidence that every manufacturing step, for every product and between different batches of the same product, is controlled, documented and meets accepted standards of robustness, repeatability and reliability.

Sampling and testing is not limited to final product only. All production stages overall must be controlled, consistent and comply with all predetermined criteria and specifications.

Smart, rationalized, robust and risk-based validation approaches can significantly decrease the number and costs of routine tests and analyses, as well as improve product quality.


Which industries require validation?

Validation standards have been adopted in most modern industries, including:

  • Pharmaceutical and  biotechnology
  • Medical device
  • Veterinary and pet products
  • Chemistry and analytical
  • Cosmetics
  • Over the counter (OTC) drugs and preparations
  • Food and food/dietary supplements
  • Software and computerized systems
  • Computer science
  • Engineering


Validation types

Validation for the pharmaceutical, biotechnology, food/food supplement, medical devices and cosmetics industries cover the following:

  • Production facilities (clean and controlled rooms)
  • Infrastructure, utilities and supplies (HVAC, water, compressed air, process gases, steam, etc.)
  • Manufacturing equipment, components and devices
  • Manufacturing processes
  • Cleaning procedures
  • Decontamination and sterilization processes
  • Packaging and labeling processes
  • Software and computerized systems
  • Control and automation systems
  • Testing and measuring devices
  • Analytical system and equipment
  • Analytical methods
  • Storage areas
  • Supply chain


Validation documentation and protocols include:

  • Validation policy
  • Validation master plan (VMP)
  • Validation protocols
  • Impact, criticality and risk assessments
  • User requirement specifications (URS)
  • Design review (DR)
  • Design qualification (DQ)
  • Installation qualification (IQ)
  • Operation qualification (OQ)
  • Performance qualification (PQ)
  • Process performance qualification (PPQ)
  • Revalidation (periodic requalification)
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