Pre-screening GMP Audit

We perform Quality and Compliance Audits of manufacturing sites in accordance to the National and International regulations. Depending upon the client’s requirements, the focus of the audit can be:

• GMP compliance
• GLP compliance
• Investigation and Root Cause Analysis
• Self-inspection
• Pre-approval inspections
• On-going compliance to QMS requirements
• Gap analysis pertaining tofacility, processes, documents and systems
• Pre-screening / Feasibility assessment
• Vendor audits

If desirable, we also providesupport in recommending and reviewing the CAPA for submission to theinspecting authority.