In its 2011 Guidance for Industry on Principles and Practice of Process Validation (1), FDA radically changed its interpretation of process validation. Validation now means “the collection and ...

The author discusses the collection and evaluation of data part of FDA’s definition of process validation. Process validation is more than just running three consecutive batches under manufacturing ...

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 ...

The track by which API manufacturing processes are prepared for commercial use is comparable to overlapping integrative process evaluations at commercial scale. This ensures the process is ...

Process, Validation, Disclosure. Legal News and Analysis - USA - Telecommunications, Media & Technology - Conventus Law ...