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Operational Guide to the Implementation of EU GMP Annex 1 (Rev. 2022)
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QA Manager Operational Guide – Deviation, CAPA, and Audit Readiness
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Qualified Person (QP) Operational Guide – Annex 16 / Batch Release
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Technical Guide for Manufacturing Managers in Pharmaceutical Companies
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The GDP Responsible Person: A Complete Guide to Good Pharmaceutical Distribution
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Introduction to PIC/S: Structure, Functioning, Documents and Aide-Memoires
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ICH Multidisciplinary Guidelines M – CTD/eCTD, Stability, Bioequivalence & Global Submissions
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ICH Quality Guidelines Q – The Complete Guide to Q8, Q9, Q10, Q12
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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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USP 382 – Implementation Guide for Parenteral Closure Systems
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