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ICH Safety Guidelines – Toxicology, Genotoxicity, Carcinogenicity & Risk Assessment
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SOP – Analytical Method Validation (AMV)
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SOP: Self-Inspections in the Pharmaceutical Sector
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QC Reference Standards in Pharmacopoeias: GMP Management Between USP and Ph. Eur.
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Dissolution Testing and Compendial Methods in GMP Pharmacopeias – Audit-Ready Operational Guide (USP, Ph. Eur.)
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USP 382 – Implementation Guide for Parenteral Closure Systems
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Validation Master Plan (VMP) GMP: How to Govern Validation and Defend It in EMA, AIFA, FDA and PIC/S Audits
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