GMP Non-Compliance: SOPs Not Updated for Revised Annex 1
GMP Non-Compliance: SOPs Not Updated for Revised Annex 1 Annex 1 Compliance Gaps: Outdated SOPs in Sterile Pharmaceutical Operations Introduction to the Audit Finding 1. Nature of the Gap Standard Operating Procedures (SOPs) in sterile manufacturing were not revised to reflect the latest EU GMP Annex 1 (2022) updates. 2. Significance of Annex 1 (2022)…
Read More “GMP Non-Compliance: SOPs Not Updated for Revised Annex 1” »