PDA journal of pharmaceutical science and technology
Mar 3, 2025
This review paper explores the transformative impact of Artificial Intelligence (AI) on Continued Process Verification (CPV) in the biopharmaceutical industry. Originating from the CPV of the Future project, the study investigates the challenges and ...
PDA journal of pharmaceutical science and technology
Jun 15, 2023
With machine learning (ML), we see the potential to better harness the intelligence and decision-making abilities of human inspectors performing manual visual inspection (MVI) and apply this to automated visual inspection (AVI) with the inherent impr...
PDA journal of pharmaceutical science and technology
Sep 19, 2022
According to the standard guidelines by the FDA, process validation in biopharma manufacturing encompasses a life cycle consisting of three stages: process design (PD), process qualification (PQ), and continued process verification (CPV). The validit...
PDA journal of pharmaceutical science and technology
Aug 14, 2020
Quality is defined by the American Society for Quality (ASQ) as "the totality of features and characteristics of a product or service that bears on its ability to satisfy given needs." Therefore, quality is applicable to processes that supply outcome...