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Two sides to the Same Coin: Qualification vs. Validation

Qualification vs. Validation

The concept of qualification vs validation has been a topic permeating the pharmaceutical industry. As discussed in FDA’s Guidance for Industry Process Validation: General Principles and Practices, qualification is part of validation, but, the qualification alone does not constitute the process of validation. So let's take a minute to recap and simplify...


Simply put, a user must qualify the equipment or facility in order to validate the process.

Qualification is related to a particular piece of equipment or whether the facility is able to achieve a set of established criteria to show the equipment or facility is fit for use. Subpart C of the cGMP regulations require the assurance of a facility’s proper design and qualification includes the utilities and equipment needed to manufacture products.

Qualification is generally divided into four stages:

  1. Design
  2. Installation
  3. Operation
  4. Performance

The extent to which qualification must be completed is based on risk and the importance of the equipment, system, or facility to the process or procedure. In addition to establishing the qualification criteria, the minimum re-qualification frequency must be established. This can be adjusted based on factors such as changes to the system, or equipment, or the ongoing analysis of calibration and maintenance results.


Validation applies to processes and procedures as a whole and demonstrates the capability to reliably reproduce the desired outcome. It is a documented and systematic approach to show that the applied system or process can operate within a set of parameters. It involves the constant collection and analysis of data.

This data is continually fed by the qualification process that maintains equipment and facilities. Ultimately, trending this data provides the relevant statistical analysis needed to show variability, stability, and capability. Continued monitoring is also needed for both qualification and validation to identify improvements and optimizations. 

Validation and qualification are a continuous process in cGMP manufacturing. The extent to which qualification or validation must be completed can be evaluated in a risk assessment to determine the direct or indirect impact on product quality and patient safety.

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Our IT Quality & Compliance experts have the domain knowledge and practical business experience to assess risk and manage complex validation/qualification initiatives, all while keeping your procedures stabilized and compliant. If your organization is in need of guidance through the process, we'd love to chat. Choose your availability via the real-time calendar below.

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