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The 3 Stages of Process Validation

April 9, 2014 by
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What is process validation?

Process validation refers to the documented evidence that processes are operated within established parameters and that it can perform effectively to fulfill its intended purpose. With the FDA asking for more scientific arguments to support activities, the “life cycle” approach to process validation was born, as it provides opportunities for process validation across the entire product lifecycle.

The lifecycle approach to process validation can be described in three stages:

1.    Process design and development

The first step in the process requires four main activities be performed: Definition of Quality Target Product Profile or (QTPP), in other words, how you want your product to look like and behave. Definition of Critical Quality Attributes (CQAs), the features that are important to you in meeting the target profile. Definition of Critical Process Parameters (CPPs), which are the limitations or restrictions that may impact your product during manufacturing. When defining your CPPs you will also consider the features of machinery and equipment, such has operating ranges, speed, compression force etc. Finally, a risk assessment based on the anticipated interaction of your Raw Materials and Process Components and their impacts on CQAs.

At the end of stage 1 you will have 5 major outputs:

• The determination and verification of the critical process parameters
• A high degree of understanding of the interaction between the CPPs, Material Attributes and the CQAs.
• Established process limits and operating ranges through your design of experiment activities.
• Risk assessment and mitigation, or control strategy.
• A report that contains all the information required for Stage 2 or Process Qualification.

2.    Process Qualification

The focus of the process qualification stage is to evaluate if the process is capable of reproducible commercial manufacturing. This is accomplished through the manufacturing of a number of commercial batches.

Remember that we design our protocols based on the product and process understanding gathered in the design stage. A lot of the information that goes into the protocol can be extracted from your Technical Transfer Reports developed in stage 1. Information such as the Critical Process Parameters (CPPs), Critical Quality Attributes, and your control strategy or the testing that will be required at the different stages of manufacturing.

The results of the testing will provide the evidence and confidence that the process is capable of yielding reproducible quality product, within the established parameters.

The major output at the end of this phase is the “Stage 2 Report.” This report documents adherence to the process qualification protocol, provides a summary of data collected and the result of the analysis providing evidence of process control.

3.    Process maintenance

This phase requires a state of control be maintained during routine commercial production, in tandem with continuous monitoring and verification of each step in the process. Any deviations encountered will trigger the need for further testing and risk assessment.

Ultimately, this type of process validation aims to verify the critical activities of production to ensure standardization, efficiencies, and quality throughout the entire product lifecycle.

Click here for information on how our automated validation solution, Validator, can help you fulfill your process validation needs.

Stay tuned next week for the complement to this post on the implementation of Quality by Design (QbD) principles into an organization’s process validation practice.

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