Practical GMP guides, tied to the clause
How the work is actually done on a GMP site, what inspectors look for, and what a defensible record looks like. Written for the people who make and review the records.
Human error in root cause analysis: why it is rarely the real root cause
Why GMP inspectors reject 'human error' as a root cause, the four error types, the questions that find the real cause, and CAPA that works better than retraining.
11 minRead the guide Data integrityAudit trail review checklist: what to look for, how often, and how to record it
A practical GMP audit trail review checklist: what to review, risk-based frequency, the red flags inspectors find, and how to document a review that stands up.
10 minRead the guide Change controlChange control risk assessment: how to make it defensible to an inspector
How to run a change control risk assessment that survives inspection: scope, impact questions, rating logic, linking CAPA, and a weak versus defensible example.
9 minRead the guide Deviation managementDeviation management in pharma: the process step by step
The GMP deviation management process in eight steps: detection, containment, classification, investigation, impact, CAPA, batch disposition and closure, with timelines.
12 minRead the guide