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What You Need to Know About GAMP® 5 Guide, 2nd Edition

ISPE

Since the publication of the first edition, GAMP ® 5 has been far and away the leading international guidance on GxP computerized systems validation and compliance. It was time for ISPE to update this key guidance document to reflect technological progress.

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Considerations for a Decentralized Manufacturing Paradigm

ISPE

Considerations for a Decentralized Manufacturing Paradigm Trudy Patterson Mon, 09/11/2023 - 06:47 Features September / October 2023 Considerations for a Decentralized Manufacturing Paradigm Marquerita Algorri, PhD Ting Wang, PhD Jocelyn X. These new operating models can help enable and accelerate the efforts of Pharma 4.0™