An article from Regulatory Focus, a RAPS Publication [link], shares intriguing insights about validation from the FDA in its warning letter [link] to Intas Pharmaceuticals Limited. One paragraph particularly stands out, resembling the kind of material we might use in process validation training.

“Process validation evaluates the soundness of design and state of control of a process throughout its lifecycle. Each significant stage of a manufacturing process must be designed appropriately and assure the quality of raw material inputs, in-process materials, and finished drugs. Process qualification studies determine whether an initial state of control has been established. Successful process qualification studies are necessary before commercial distribution. Thereafter, ongoing vigilant oversight of process performance and product quality is necessary to ensure you maintain a stable manufacturing operation throughout the product lifecycle.”

The warning letter itself, preceding the quoted paragraph, details specific expectations for process validation in batch manufacturing. It cites the current validation study for its inadequate evaluation of variations within and between batches. A particular point of concern is the inconsistency in process time, attributed to varying operator judgments.

The company in question has agreed to conduct statistical evaluations as part of its process validation. Using mean and standard deviation derived criteria can be effective in assessing the process. However, focusing only on output performance can overlook the importance of input. This is where a Six Sigma approach adds value, offering deeper insights into process operations. A validation becomes more comprehensive when you understand how controlling process parameters can reduce the likelihood of producing defective products.

Ready to redefine validation with Six Sigma? Connect with us on LinkedIn or Facebook to explore how we can transform your processes together.

About Brayearst Validation Consulting

Brayearst Validation Consulting leverages Six Sigma methodologies to provide targeted validation services for the life sciences industry. We specialize in process, cleaning, software, and analytical test method validation, ensuring compliance with FDA requirements while optimizing operations for efficiency and quality. Our team combines technical expertise with a deep understanding of regulatory standards to deliver process-driven validation documents that withstand rigorous auditor scrutiny. From strategy development to study execution, we empower our clients to achieve operational excellence and bring high-quality products to the market with confidence.