Module 5 Presentations

Learning from Inspections

Be inspection ready rather than fire-fighting when the notification is received

Develop procedures and ensure appropriate training and usage

Useful documentation to support that you followed a process

Ongoing maintenance of the quality management system

Time to think and plan

Develop understanding of your systems and processes and how they interact

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Inspection Differences 1

MHRA

EMA-coordinated

FDA

Dedicated GCP inspectors

EMA has no inspectors. Inspectors are from Member States (some have dedicated GCP inspectors)

Investigators

Usually 1-2 inspectors (more if large organisation) National and MAA-related Mainly systems and some trial specific

At least 2 inspectors

Usually single FDA investigator (and perhaps an SME) IND Application-related only Mainly trial -specific application related although systems approach being explored

MAA-related only Mainly trial -specific, (triggered or routine)

Inspection plan shared

Inspection plan shared Mixture of interviews and document review

No inspection plan

Mixture of interviews and document review and sometimes includes Office Based Inspections

Mainly document review

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