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lab audit
GMP Lab Audit & Certification Readiness
GMP compliance audit and certification preparation
2-4 weeks
NDA Required
Scope
Complete assessment of manufacturing facilities, processes, documentation, and quality systems against GMP requirements.
Deliverables
Detailed audit report
Gap analysis
Remediation action plan
Pre-certification review
Staff training recommendations
Prerequisites
- Existing quality manual
- Process documentation
- Facility access
Applicable Jurisdictions
ISO 22716
FDA cGMP
EU GMP