Process Validation Solutions

Process Validation Overview

Process validation is a critical component of product development. According to the U.S. Food and Drug Administration (FDA), process validation involves establishing documented evidence that a specific process, such as the manufacture of pharmaceutical dosage forms, will consistently produce a product that meets predetermined specifications and quality characteristics.

Stages of Process Validation

Process validation encompasses a sequence of activities throughout the product lifecycle, categorized into three stages:

1. Process Design: This initial stage defines the commercial process based on knowledge gained from development and scale-up activities.
2. Process Qualification: In this stage, reproducibility is confirmed, demonstrating that the process design is capable of consistent commercial manufacturing.
3. Continued Process Verification: This ongoing stage ensures that the process remains in a state of control during routine production.

Process validation includes collecting and evaluating data from the process design stage through to production, establishing scientific evidence that the process can consistently deliver quality products.

Regulatory Requirements

Process validation is mandated by current Good Manufacturing Practices (cGMPs) for finished products, including pharmaceuticals (21 CFR 211) and medical devices (21 CFR 820). According to section 820.75 of the FDA regulations:

• (a) "Where the results of a process cannot be fully verified by subsequent inspection and test, the process shall be validated with a high degree of assurance and approved according to established procedures. The validation activities and results, including the date and signature of the individual(s) approving the validation and, where appropriate, the major equipment validated, shall be documented."
• (b) "Each manufacturer shall establish and maintain procedures for monitoring and control of process parameters for validated processes to ensure that the specified requirements continue to be met."

ISO 13485:2016 similarly states that organizations must validate any processes for production and service provision where the resulting output cannot be verified by subsequent monitoring or measurement.

SOMA’s Process Validation Solutions

SOMA's Process Validation Solutions team consists of experts dedicated to guiding and supporting you through all stages of development to achieve validated process status. We will help you create a master plan and navigate the validation protocols, which include mapping the processes along with all related resources that need validation. Based on the final product type, we can develop a customized Process Validation Solution to mitigate risks and challenges in manufacturing a quality product.