| name | prepare-inspection-readiness |
| title | Prepare Inspection Readiness |
| description | Prepare an organisation for regulatory inspection by assessing readiness against agency-specific focus areas (FDA, EMA, MHRA). Covers warning letter and 483 theme analysis, mock inspection protocols, document bundle preparation, inspection logistics, and response template creation. Use when a regulatory inspection has been announced or is anticipated, when a periodic self-assessment is due, when new systems have been implemented since the last inspection, or after a significant audit finding that may attract regulatory attention. |
| author | pjt222 |
| author_url | https://github.com/pjt222/agent-almanac/tree/main/i18n/caveman-lite/skills/prepare-inspection-readiness |
| license | MIT |
| version | 0.1.0 |
| execution_mode | open |
| jurisdiction | general |
| practice | life-sciences |
| language | en |
Prepare Inspection Readiness
Assess and improve organisational readiness for regulatory inspection, covering documentation, personnel preparation, logistics, and response planning.
When to Use
- A regulatory inspection has been announced or is anticipated
- Periodic self-assessment of inspection readiness is due
- New systems or processes have been implemented since the last inspection
- Industry trends (warning letters, 483s) indicate an emerging focus area
- After a significant audit finding that may attract regulatory attention
Inputs
- Required: Inspecting authority (FDA, EMA, MHRA, or other)
- Required: Expected inspection scope (data integrity, CSV, GMP, GLP, GCP)
- Required: Compliance architecture and system inventory
- Optional: Previous inspection reports and observations
- Optional: Recent industry warning letters and 483 themes
- Optional: Open CAPAs and audit findings
Procedure
Step 1: Analyse Agency-Specific Focus Areas
Research the inspecting authority's current priorities:
# Inspection Focus Area Analysis
## Document ID: IFA-[SITE]-[YYYY]-[NNN]
### FDA Current Focus Areas
| Focus Area | Regulatory Basis | Recent 483 Trends | Risk to This Site |
|-----------|-----------------|-------------------|-------------------|
| Data integrity | 21 CFR Part 11, CGMP | #1 cited observation in drug 483s since 2016 | [H/M/L] |
| Audit trail | 21 CFR 11.10(e) | Disabled/incomplete audit trails | [H/M/L] |
| Electronic signatures | 21 CFR 11.50-11.300 | Missing manifestation, shared accounts | [H/M/L] |
| Computer system validation | GAMP 5, FDA guidance | Inadequate validation of Category 4/5 systems | [H/M/L] |
| Change control | ICH Q10 | Undocumented or retrospective changes | [H/M/L] |
| Laboratory controls | 21 CFR 211.160-211.176 | OOS investigation, test repetition | [H/M/L] |
### EMA/MHRA-Specific Considerations
| Area | EU Annex 11 Reference | Focus | Risk to This Site |
|------|----------------------|-------|-------------------|
| Computerized system validation | §4, §5 | Risk-based validation, supplier assessment | [H/M/L] |
| Operational phase | §6-§13 | Security, audit trail, backup, business continuity | [H/M/L] |
| Cloud and outsourced systems | §3.4 | Service level agreements, data sovereignty | [H/M/L] |
| Data governance | MHRA DI guidance | ALCOA+, culture of integrity | [H/M/L] |
Got: A risk-rated analysis of inspection focus areas specific to the inspecting authority.
If recent 483/warning letter data is unavailable, consult the FDA warning letter database, EMA inspection reports, or industry publications for the most current trends.
