A comprehensive GAP Assessment identifies deficiencies in facilities, quality systems, documentation and manufacturing practices before they become regulatory observations. Our experts perform detailed assessments against applicable GMP standards and provide practical remediation plans to achieve sustainable compliance.
What We Deliver
- Comprehensive GMP GAP Assessment — Assessment of facilities, equipment, documentation and quality systems against applicable GMP standards.
- Facility & Utility Review — Evaluation of cleanrooms, HVAC, purified water systems, compressed gases, utilities and engineering controls.
- Documentation GAP Review — Assessment of SOPs, validation documents, specifications, protocols, quality manuals and records.
- Quality System Assessment — Review of CAPA, deviations, change control, complaints, recalls, risk management and training systems.
- Data Integrity Assessment — Evaluation of documentation practices, computerized systems and ALCOA+ compliance.
- Inspection Readiness Evaluation — Assessment of personnel preparedness, documentation and facility compliance before regulatory inspections.
- Risk-Based Remediation Plan — Prioritized corrective actions with timelines and implementation recommendations.
Our Approach
01
Scope Definition
Understand facility type, applicable GMP standards and assessment objectives.
02
On-site GAP Assessment
Conduct detailed review of facilities, quality systems, utilities, documentation and manufacturing operations.
03
GAP Report & Risk Prioritization
Issue a structured report categorizing observations as Critical, Major or Minor, with supporting evidence.
04
Remediation Support
Assist in developing CAPA, implementing corrective actions and verifying compliance before regulatory inspection.
Who this is for
Pharmaceutical ManufacturersAPI ManufacturersMedical Device ManufacturersGreenfield & Brownfield ProjectsCompliance ManagersRegulatory Affairs Teams
Why Choose Vaayath
- Experienced pharmaceutical GMP consultants
- Regulatory expertise across multiple international standards
- Practical and risk-based assessments
- Independent and objective evaluation
- Actionable remediation plans
- End-to-end implementation support
Assessment Scope
Facility Design
HVAC
Water System
Warehouse
Production
QC Laboratory
QA System
Validation
Engineering
Documentation
Data Integrity
Training
CAPA
Change Control
Complaints
Vendor Qualification
Computerized Systems
Deliverables
Detailed GAP Assessment Report
Observation-wise Risk Classification
Photographic Evidence (where applicable)
CAPA Recommendations
Remediation Roadmap
Executive Summary
Follow-up Consultation