Updated FDA Process Validation Software

(Aegis Corp.: Lafayette, Colorado) -- Recent deployment of manufacturing process intelligence software “Discoverant,” from Aegis Analytical Corp., enables life science manufacturers to apply the updated principles and approaches for process validation outlined in the United States Food and Drug Administration's (FDA) “Guidance for Industry Process Validation: General Principles and Practices,” draft published in November 2008.

The FDA published updated draft guidance on process validation, which it defines as “the collection and evaluation of data, from the process design stage throughout production, which establishes scientific evidence that a process is capable of consistently delivering quality products.” To leverage knowledge and understanding as the basis for establishing an approach to control that is appropriate for the manufacturing process, the FDA guidance recommends that manufacturers:

• Understand the sources of variation 
• Detect the presence and degree of variation
• Understand the effect of variation on the process and ultimately on product attributes
• Control the variation in a manner commensurate with the risk it represents to the process and product.

“The FDA states that ‘information transparency and accessibility are essential’ to making informed, science-based decisions that lead to product commercialization,” says Justin Neway, Aegis founder and chief science officer. “You have to have the right tools in place to access, aggregate, and analyze data on-demand in a meaningful context during process design and commercial operations.”

The FDA identified the following specific stages and activities of process validation in the product life cycle:

Stage 1: Process design: The commercial process is defined during this stage based on knowledge gained through development and scale-up activities.
Stage 2: Process qualification: During this stage, the process design is confirmed as being capable of reproducible commercial manufacturing.
Stage 3: Continued process verification: Ongoing assurance is gained during routine production that the process remains in a state of control.

“The FDA is pointing manufacturers to practices that can continuously improve their process understanding and, therefore, their process validation,” says Robert Di Scipio, Aegis president and CEO. “Discoverant can help across all stages of the product life cycle to derive scientific knowledge that will make the process validation program more effective and efficient.”

Aegis' Discoverant is a commercial off-the-shelf (COTS) software system specifically designed to help understand the sources of variability in complex manufacturing processes. It enables on-demand and scheduled access to data in disparate data sources such as paper records, data historians, manufacturing execution systems (MES), laboratory information management systems (LIMS), and other databases and data warehouses in one validatable environment. Discoverant helps to provide process understanding, which is used to increase process predictability, reduce process start-up risks, improve product quality and variability, decrease cycle times and assure compliance with good manufacturing practices (GMP) in FDA-regulated production and packaging environments.

For further information, visit www.aegiscorp.com/uploads/Aegis_FDAGuidance_Release_FINAL.pdf.

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