SOPs Not Aligned with Updated Annex 1 Requirements: A GMP Compliance Gap
SOPs Not Aligned with Updated Annex 1 Requirements: A GMP Compliance Gap Impact of Unaligned SOPs with Revised EU GMP Annex 1 on Regulatory Compliance Introduction to the Audit Finding 1. Annex 1 Revision: A Paradigm Shift The revised EU GMP Annex 1, effective August 2023, introduced key changes to sterile manufacturing expectations. 2. SOP…
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