Validation- What is it?

Validation- What is it?

2020-08-30T09:10:19+00:00January 27th, 2016|

What is Validation?

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

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

Since the middle of the 20th century, control and traceability of products which have Pharmacological and/or Medical treatment effects and/or have impact on human/animal health conditions turned to be in focus of governmental heath authorities and public awareness. As a result, FDA developed standards and requirements in order to assure customer safety and health. These requirements were detailed in chapter 21 of the FDA Code of Federal Regulations (CFR). 1.3  Consequently to FDA and other world health authorities decisions to increase product surveillance; Pharmaceutical, Biotech and Medical Device industries created new Verification and Validation procedures which aligned with FDA and other authorities and patients requirements toward improved product quality, safety and efficacy. These activities included testing, documentation, process standardization, controls and providing methods for full traceability of each manufactured product, from raw material receiving, production through the entire supply chain. 1.4  Validation and Qualification are general term used to cover all the efforts performed for this goal: to approve and assure reliability, quality, safety and efficacy of Pharmaceutical and Medical products.

Why we validate?

Validation is to demonstrate that a pharmaceutical/medical product complies with all quality, safety and efficiency requirements. The validation process is documented evidence for every manufacturing step, for every product and between different batches of the same product being controlled, documented and meeting robustness, repeatability and reliability standards. 2.2  Sampling and testing is not limited to final product only. All production stages as a whole, have to be controlled, consistent and comply with all pre-determined criteria and specifications. 2.3  Smart, rationalized, robust and risk based Validation approaches can decrease significantly the quantities and costs of routine tests and analysis on the one hand, and to improve product quality on the other.

Which industries require Validation?

Validation has been adopted as a standard in most of the modern industries such as:

  • Pharmaceutical and  Biotechnology
  • Medical device
  • Veterinary and pets products
  • Chemistry and analytical
  • Cosmetics and OTC
  • Food
  • Food supplements
  • Software and computerized system
  • Computer science
  • Engineering

Validation types

Validation for Pharmaceutical, Biotechnology, Food, Food supplements, Medical Devices and Cosmetics will cover the following aspects:

  • Production facility (clean and controlled rooms)
  • Infrastructure and supplies (HVAC, water, compressed air, process gases, steam etc.)
  • Manufacturing equipment, components and devices
  • Manufacturing process
  • Cleaning procedures
  • Decontamination and sterilization
  • 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 will include the following:

  • Validation policy
  • Validation Master Plan
  • Validation Plan
  • Impact, criticality and Risk Assessments
  • URS- User Requirements Specifications
  • DR- Design Review
  • DQ- Design Qualification
  • IQ- Installation Qualification
  • OQ- Operation Qualification
  • PQ- Performance Qualification
  • PPQ- Process Performance Qualification
  • Re-validation (periodic Re-Qualification)


About the author:

Eran Yona Bio-Chem CEO and GxP consultant


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