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.

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