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SOP: Self-Inspections in the Pharmaceutical Sector

SOP: Self-Inspections in the Pharmaceutical Sector

€39,00 EUR
€39,00 EUR
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This comprehensive operational guide provides a clear, audit-ready framework for managing Self-Inspections (internal audits) in the pharmaceutical sector, in full compliance with European and international regulations.

✅ Based on key SOPs and major guidelines: EU GMP Annex 1, Annex 15, Annex 16, ICH Q9/Q10, WHO TRS, FDA 21 CFR, ISPE GAMP5, PIC/S.
✅ Structured in 10 operational chapters, with examples, tables, editable templates, and ready-to-use checklists.
✅ Includes process flowcharts, RACI matrix, key quality KPIs, and real case studies (Grade A/B deviation, QC OOS, label reconciliation).
✅ Authoritative yet practical style: immediately applicable by QA Managers, Qualified Persons, Validation Experts, Regulatory Affairs, and Internal Auditors.

Inside you’ll find:

Master Checklists for Production, QC, QA, Warehouse, Sterile/Annex 1, Engineering, and Data Integrity.

Operational templates (Annual schedule, Inspection report, CAPA plan, Follow-up report).

Self-Inspection process flowchart (Mermaid code).

Self-Inspection Ready section: 10 operational steps, 10 red flags, 10 KPIs.

Precise regulatory references (Annex 1 / ICH / FDA / WHO with links).

Format: Professional PDF
Length: 41 operational pages
Updated: December 2025 – compliant with the latest GMP revisions

Available languages: ITA – ENG

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