The Validation Process: what are its components and when to implement it?

Over many years of managing various validation processes, we encountered a number of questions that were raised by our customers, both prior and during the process. These questions were mainly concerned about:

  • The correct planning of the process
  • When to implement the process – and in which industries is the validation process required?

To address these (and other) questions, we decided to create this post in order to gather all relevant and useful information.

Our main goal is to ensure you have the tools you need to make the correct decisions during the validation process.

What is “Validation” and why is it required?

Validation is a process that eventually results in documented proof to provide a high-level of confidence that a process, method or equipment meets predefined performance criteria. It also ensures a consistent production process within the boundaries of the specification limits and defined quality attributes.

Validation is actually a regulatory requirement in various industries and can have a significant impact on product quality requirements.

For example: the validation process for pharmaceutical and medical devices ensures that the product complies with all the quality, efficiency and safety requirements defined for it from the production stage throughout its lifecycle and until its expiration. It is therefore important to manage, execute and approve the process via authorized parties.

When is a Validation Process required?

A validation process is typically required for the following scenarios:

  • New process / facility / method
  • The adding of a new device or equipment to an existing production facility
  • After unscheduled maintenance or repairs
  • After any adjustments / modifications to equipment / process / method
  • After copying a location

In which industries is the Validation Process relevant?

The validation process is necessary and relevant for many industries, including:

  • Medical devices – validation services for medical devices.
  • Pharma (pharmaceutical) industries – validation and certification services for manufacturing processes, laboratory equipment and analytical methods.
  • Biotechnology, and the food and nutritional supplements industries.

For more information – please contact Q.C.C. validation process experts.