The author describes various manufacturing processes and evaluates whether the guidance can be applied to each of them. In November 2008, the US Food and Drug Administration issued Draft Guidance for ...

“AI can create digital replicas of manufacturing processes, allowing companies to model ‘what-if’ scenarios, ... EMA’s Annex 15 on Process Validation, ...

This capability also provides the advantage of enhanced assurance of intra-batch uniformity. Using this approach, data from production batches can essentially support validation with each ...

As countries begin to establish AI regulations, engineers designing AI-enabled systems must meet newly introduced ...

The GMP Validation Program is valued at approximately $4.1 million and is inclusive of the following activities: cell line verification, legacy process verification, GMP scale-up production, drug ...