The FDA has set up something known as process validation that needs to be present in any pharmaceutical company. This process is the basic collecting and evaluating data, starting at the process design stage all the way through commercial production. This is meant to help establish scientific evidence that a process will be able to deliver a quality product consistently. 

One tenant that comes with this kind of guidance is the lifecycle concept. With this approach, we are not just concerned about the initial drug development processes, though this is important. We are also worried about all the other components that go into such as commercial manufacturing, routine commercial product, and everything until the product is discontinued. 

There are three main parts that come with process validation. These stages include: 

# Process design: This is when the company will define their own commercial manufacturing process.

# Process qualification: This is where the design is evaluated to determine whether the process is safe and if it can be reproduced in a safe manner.

# Continued process verification: This is assurance that will be ongoing to make sure that all of the processes can remain in a state of control.

Keep in mind that before any of the activities for manufacturing and commercializing the product, all manufacturers need to go through the necessary steps to show they met the required quality standards and that their product is safe and effective to use by the consumer. 

As a manufacturer, it is important to understand some of the different variations of the drug product and any of the active ingredients inside that may happen when you do scale-up activities. If there are variations, the company needs to know the degree, source, and impact of the variation. FDA mandates help to control any of the variations as well. 

The major objective here is to design, create, and maintain the manufacturing process in order to produce a pharmaceutical that will meet several critical components including: 

# Potency

# Purity

# Quality

# Strength

# Identity 

Through the right training on process validation, it is easier to meet all of these standards in your company. They may seem a bit severe in different cases, but they are there to help make sure the product turns out exactly how it promises and that no customers are harmed when they take the pharmaceutical. Failure to monitor the variances or to take care of the product could lead to some major issues later on for the company.