SOP: Self-Inspections in the Pharmaceutical Sector
SOP: Self-Inspections in the Pharmaceutical Sector
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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What will I find in this guide?
In addition to operational explanations of the relevant regulations, you will find checklists, templates, real-life cases, and common mistakes to avoid.
How up-to-date is the guide?
The guide includes updated references to the latest EMA and EU GMP regulations, as well as guidance from all international inspection bodies. In the event of future revisions, we expect updates to be made available to buyers.
How long is it and how long does it take to read?
Each guide has a specific length based on the complexity of the topic, but they are all designed for quick reference. You can use it as a daily reference manual.
Who is this guide most useful to?
Junior professionals → to learn quickly and reduce errors.
Senior professionals → to have ready-to-use checklists and templates to share with the team.
Can I download it multiple times or share it?
Once purchased, you can download and keep it. It is for personal or internal business use only, but external redistribution is not permitted.