Know your compliance posture before the authorities arrive.
Independent system-based audits and practical support to remediate gaps in advance.
System-Based Facility GMP Audits
Comprehensive audits covering facilities, utilities, process equipment, laboratory instruments, computerized systems and the QMS — with a gap analysis, improvement recommendations and follow-up of their implementation.
GMP Audit Preparation & Support
Audit strategies for regulatory, customer or third-party inspections: preparing internal expert teams, running mock audits and providing on-site support during the inspection itself.
Vendor Qualification & GMP Audits
Planning, execution, reporting and follow-up of audits at domestic and international API manufacturers, as well as supplier audits to evaluate the GMP compliance of critical service providers and contract manufacturing organizations.
Audit scope & focus areas.
- Facilities & Contamination Control (CCS)
- Utilities
- Process equipment
- Analytical & laboratory instruments
- Computerized systems & data integrity
- Quality Management System (QMS)
- Supply chain & cold chain management
- API manufacturers
- CMOs
Step into your next inspection with absolute confidence.
Regulatory, client or third-party audits — let’s architect your winning strategy together.