By: Edward Simpson

edward_imgProcess validation is the guiding principle that ensures consistency, quality, and safety of products in every unit that manufactures food and drugs. It is an ongoing process that plays a vital role in the designing, prototyping, and manufacturing of food and drug products. The Food and Drug Administration (FDA) process validation enlists various concepts and components that manufacturers must adhere to in order to achieve the desired product performance and quality. Strict adherence to these standards and specifications is needed for an FDA approval, which also ensures the well-being of the end-user. Process validation also improves process capabilities, lowers scrap, and increases the yield while lowering the cost of production.

While it is important to know that process validation will vary depending on the nature of products, this post provides a fundamental framework that will serve as a guideline for manufacturers who want to stay consistent, compliant, and competitive:

Stages of FDA Process Validation

Process validation is classified into three distinct stages:

  1. Process Design—This stage is focused on defining a commercial production process that will deliver consistent results. To build and capture scientific process knowledge, manufacturing and scale-up methods are broken down into smaller individual segments. These are then studied and analyzed (taking variables into account) to gauge their effect on critical quality attributes (CQAs) of the final product.
  2. Process Qualification—At this stage, a process is evaluated to make an assessment of whether it can be effectively and consistently reproduced for all batches in commercial production. It’s further divided into two sub-stages, both crucial for FDA approval:
    • Facility Design & Equipment/Utility System Qualification
    • Performance Qualification
  3. Continued Process Verification—Implemented during routine production, this stage allows manufacturers to maintain control over commercial manufacturing processes on an ongoing basis. It offers this assurance through the periodic collection, review, and assessment of data that reflects the stability and capability of a process, especially focusing on variables that affect product CQAs.

    Dr Michael Low

    Dr Michael Low

Frequency of Validation Program Assessment

Every step in the manufacturing process needs to be revalidated and documented on a frequent basis, especially after changes in:

  • raw materials or their physical properties;
  • facilities or equipment;
  • temperature/pressure, mixing conditions, and other processes;
  • production areas;
  • support systems;
  • calibration services, etc.

How Do FDA Process Validation Guidelines Help with Quality Assurance?

Food and pharmaceutical quality is directly linked to public health and safety. FDA validation guidelines act as a benchmark, providing a clear set of instructions for you to follow. As a result, there’s less disparity in composition, effectiveness, safety, and overall quality of similar products or different batches/units.

These guidelines aim to promote:

  • innovation;
  • process improvement;
  • modern manufacturing principles; and
  • risk assessment and control.

Combined with pharmaceutical cGMP (current Good Manufacturing Practice) compliance and batch release testing, effective validation allows your company to gain trust and improve its reputation. It also streamlines production, minimizes health and safety risks, and reduces the chances of facing penalties after a regulatory inspection.

If you’re unsure of how to develop, implement, and execute procedures for FDA process validation, seek expert advice. A reputed calibration, validation, and compliance service provider can help you get it right!

Edward Simpson is a seasoned Calibration and Technical Engineer working for RS
Calibration Inc. Edward has a knack for finding faults in machines and does not rest until they are rectified to perfection. He lives in Pleasanton, CA and can be contacted anytime for matters related to machines on his email He also invites people to visit his company to learn more about the type of calibration work he does.