GMP Inspection & Pre-Audit Services
Comprehensive GMP compliance assessment and preparation services to ensure your facility meets EFDA and WHO standards.
GMP Compliance Excellence
Good Manufacturing Practice (GMP) compliance is essential for pharmaceutical companies operating in Ethiopia. EFDA requires all manufacturers to adhere to WHO-GMP standards to ensure product quality, safety, and efficacy.
YAM BUSINESS provides comprehensive GMP inspection and pre-audit services, helping pharmaceutical companies achieve and maintain compliance with Ethiopian regulatory requirements. Our team of former EFDA inspectors brings insider knowledge to help you succeed.
From initial gap assessments to mock inspections and corrective action planning, we guide you through every step of GMP compliance, ensuring your facility is inspection-ready.
Our GMP Services
Comprehensive GMP compliance services designed to prepare your facility for EFDA inspections and maintain ongoing compliance.
Comprehensive evaluation of your facility's GMP readiness
- Gap analysis against EFDA/WHO-GMP standards
- Documentation review and assessment
- Personnel training evaluation
- Equipment qualification status review
- Quality system assessment
Simulated EFDA inspection to identify areas for improvement
- Complete facility inspection simulation
- Interview preparation for key personnel
- Documentation verification process
- Critical findings identification
- Inspection readiness scoring
Development of comprehensive CAPA plans
- Root cause analysis of identified gaps
- Prioritized action plan development
- Timeline and resource allocation
- Implementation guidance
- Progress monitoring framework
Customized training for your team
- GMP principles and requirements
- Documentation and record keeping
- Quality control procedures
- Deviation and CAPA management
- Inspection preparedness
Our GMP Assessment Process
A systematic approach to evaluating and improving your GMP compliance status.
Initial Assessment
Comprehensive evaluation of current GMP status and documentation review.
Gap Analysis
Identification of gaps against EFDA/WHO-GMP requirements and prioritization.
Action Planning
Development of detailed corrective action plans with timelines and responsibilities.
Implementation Support
Guidance and support during implementation of corrective actions.
Mock Inspection
Simulated EFDA inspection to test readiness and identify remaining issues.
Final Preparation
Final review and preparation for actual EFDA inspection.
Frequently Asked Questions
Common questions about GMP compliance and our inspection services.
Our Global Clients
Trusted by pharmaceutical companies across multiple countries for EFDA compliance and Ethiopian market entry.
Our customers
JODAS EXPOIM PVT. LTD
PHARMAX INDIA PVT. LTD
Intellective Biologics (Suzhou) Co., Ltd
Skymap Pharmaceuticals Pvt. Ltd
HOF Pharmaceuticals Ltd
RENATA LIMITED
Advanov Pharma
Sovereign Pharma
Nobel İlaç (Nobel Pharmaceuticals)
EVA PHARMA
JODAS EXPOIM PVT. LTD
PHARMAX INDIA PVT. LTD
Intellective Biologics (Suzhou) Co., Ltd
Skymap Pharmaceuticals Pvt. Ltd
HOF Pharmaceuticals Ltd
RENATA LIMITED
Advanov Pharma
Sovereign Pharma
Nobel İlaç (Nobel Pharmaceuticals)