Achieving WHO-GMP or EU-GMP compliance requires more than documentation—it demands robust quality systems, validated processes, well-designed facilities and a culture of continuous compliance. Our experts help pharmaceutical manufacturers identify GMP gaps, implement practical remediation measures and prepare confidently for regulatory inspections.
What We Deliver
- Documentation Review — Comprehensive review of SOPs, specifications, validation documents, quality records and GMP documentation.
- Data Integrity Assessment — Evaluation of data governance practices and implementation of ALCOA+ principles in line with international expectations.
- QMS Strengthening — Implementation and optimization of Quality Management Systems aligned with WHO-GMP, EU-GMP and PIC/S requirements.
- Validation & Qualification Review — Assessment of process validation, cleaning validation, analytical validation and equipment qualification documentation.
- Training & Inspection Coaching — Practical GMP training, interview preparation and inspection simulations for management and operational teams.
- Observation Closure Support — Preparation of scientifically justified CAPAs and support in responding to regulatory observations following inspections.
Our Approach
GMP Gap Assessment
Conduct a comprehensive review of facilities, documentation, utilities, quality systems and manufacturing operations against WHO-GMP or EU-GMP requirements.
Remediation Planning
Prioritize identified deficiencies and develop a structured action plan with timelines, responsibilities and compliance objectives.
Implementation & Mock Inspection
Support implementation of corrective actions, strengthen documentation and conduct mock inspections to evaluate inspection readiness.
Regulatory Inspection Support
Provide on-site or remote technical support during inspections, assist with observation management and develop effective CAPAs for sustained compliance.
Why Choose Vaayath
- 20+ years of pharmaceutical regulatory experience
- Extensive experience in WHO-GMP and EU-GMP compliance
- Independent GMP gap assessments
- Practical remediation support
- On-site inspection assistance
- Expertise across formulation, API and sterile manufacturing facilities
Our GMP consulting methodology is aligned with WHO Technical Report Series (WHO-GMP), EU Guidelines for Good Manufacturing Practice, PIC/S GMP Guide, revised Schedule M and applicable international regulatory expectations.