GMP Services

EU Authority Audit Arrangements

Coordination of audits for manufacturing sites by an EU Qualified Person (QP)

Comprehensive Audit Services

• Experienced Auditor

• GAP Analysis Audit

• API Facility Inspection

• Finished Drug Product Facility, Supplier, and Subcontractor Audit

GMP Training Programs

• On-site and off-site classroom training

• Virtual GMP training for manufacturing and laboratory personnel

Site Readiness as per Revised Schedule M

• Comprehensive facility audit against Revised Schedule M requirements.

• Identification of non-conformities and risk-prone areas

• Customized compliance roadmap

Quality Management System (QMS) Implementation

Assistance in setting up QMS for new facilities.

Technical Documentation Services

• CAPA response

• Site Master File (SMF) preparation

• Sterility assurance package

• Standard Operating Procedure (SOPs) drafting

EUGMP Inspection Request

Specialized support to manufacturers in triggering EU-GMP Inspection