Industry 4.0, or the Fourth Industrial Revolution is a term used to describe the use of smart technology in manufacturing and industrial processes.
ISPE (the International Society for Pharmaceutical Engineering) has trademarked the term ‘ISPE Pharma 4.0’ to cover Industry 4.0 in the life sciences sector.
As the Industry 4.0 concept is equally...
“Our goal is to determine if the firm’s manufacturing operations are in a state of control. The CGMPs are a management-based regulatory approach. We do not specify how a company must structure its quality system. The regulations provide general expectations and we let the firm’s management structure its GMP compliance program accordingly. A GMP...
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