GP

GMP Readiness Checklist

Self-assessment across cGMP-aligned domains

Overall GMP Readiness

80%

Across 6 domains · 32 criteria evaluated

Quality Management System88%
Personnel & Training76%
Facilities & Equipment82%
Production & Process Controls71%
Quality Control & Testing84%
Supplier & Materials79%
Quality Manual approved and current
POL-QA-001 Rev 8
Met
Document control SOP in place
SOP-QA-002
Met
Annual management review completed
MR-2026-Q1
Met
Change control procedure implemented
SOP-QA-007
Met
Internal audit program defined
Gap