Frequently asked questions on CAPAs
What is the difference between corrective and preventive actions?
Corrective actions address identified root causes of existing deviations, while preventive actions mitigate potential causes before deviations occur.
What CAPA deficiencies typically result in major findings?
Weak root cause analysis, ineffective actions, missing effectiveness checks, and recurring deviations.
How do inspectors assess CAPA effectiveness?
By evaluating root cause logic, implementation quality, and objective evidence demonstrating sustained effectiveness.
When is a CAPA mandatory under EU GMP?
CAPAs are required whenever deviations, trends, audit findings, or quality risks with potential impact on product quality or patient safety are identified.
Frequently asked questions (FAQs)
Frequently asked questions on inspection readiness
What does inspection readiness mean in practice?
It means that systems, documentation, and personnel are audit-ready at all times, not only shortly before inspections.
Which areas are typically scrutinized during GMP inspections?
QMS, deviation and CAPA management, training, documentation, data integrity, and manufacturing processes.
How should staff be prepared for inspector interviews?
Through structured mock interviews, role clarity, and consistent process understanding.
When should a mock inspection be performed?
Ideally 3–6 months prior to an expected inspection or after major system changes..
Frequently asked questions on QMS gap analysis
What is a QMS gap analysis?
A structured assessment of an existing quality system against regulatory requirements and best practices.
How comprehensive is a QMS gap analysis?
It includes documentation review, interviews, and evaluation of real-life process execution.
What is the typical outcome?
A prioritized remediation roadmap with actionable recommendations.
What is the typical outcome?
A prioritized remediation roadmap with actionable recommendations.
How can you effectively help?
In some instances writing a fresh new QMS is the fastest, best option to get rid of an incoherent monster rooted in patching historic holes when the company grew. In other instances we simply fix the issues identified in the GAP-analysis, or fix outdated procedures.
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