GMP Audit Preparation & Compliance

When This Support Is Relevant

Essential prior to upcoming WHO-GMP inspections, State FDA renewals, customer audits, or when establishing a Total Quality Management System (TQMS) across manufacturing operations.

Scope of Support

• Audit Preparation Support: Facility readiness, mock inspections, and CAPA formulation for WHO-GMP and regulatory audits.
• Facility GAP Analysis: Thorough audit of existing cleanroom suites, air handling units, water systems, and documentation.
• Vendor Audits: Independent audits for raw material (RM), packing material (PM), formulation sites, public testing laboratories, and laundry vendors.
• Total Quality Management System: Implementation of QMS elements including deviation management, OOS/OOT investigations, CAPA tracking, and change control.
• GMP Compliance Advice: Ongoing advisory services for local and international regulatory updates.