Process validation is crucial for ensuring the quality of final products and the safety of these processes for manufacturing personnel and consumers in the pharmaceutical, medical device, and biotechnology industries.
Foundations of process validation References Introduction According to the United States Food and Drug Administration , process validation is collecting and evaluating data obtained throughout a product's entire lifecycle, including the initial drug development process and its commercial manufacturing1.
During the first process design stage, the commercial manufacturing process will be defined to ensure it consistently delivers a high-quality product. Product quality and manufacturing data must be reviewed periodically to determine whether any changes to these processes are needed. Key elements of process validation Many regulatory agencies worldwide, including the FDA, can legally enforce process validation procedures to ensure that final drug products consistently and reliably meet pre-determined quality standards.
This information allows manufacturers to quickly identify the sources of any variation and the extent to which this variation is causing issues, as well as understand the impact of this variation on the manufacturing process and, ultimately, product attributes. For example, many complex processes are involved in the production of pharmaceutical agents and biotechnology products, thus increasing the number of variables that can affect the quality of the final product.
Biotechnology Process Validation Drug Discovery
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