PrimeGMP offers comprehensive GMP audit and consulting services to strengthen your compliance framework, support regulatory inspections, and prepare your teams for global audits from USFDA, EMA/MHRA, WHO, PIC/S, CDSCO, and customer agencies.
Our approach ensures readiness, risk minimization, and complete compliance documentation.

1. Regulatory Audit Preparation & Readiness

We prepare your facility and teams for real inspections by:

• Reviewing facility, equipment & documentation readiness
• Conducting mock interviews for QA/QC/Production/Engineering
• Aligning practices with FDA, EU GMP, WHO TRS & PIC/S expectations
• Ensuring QMS robustness across Deviation, OOS, Change Control & CAPA
• Preparing inspection room & documentation folders
• Developing an inspection handling strategy for leadership & staff

This ensures your site is fully prepared before the auditors arrive.

2. Support During Regulatory Audits

PrimeGMP provides on-site & virtual support during inspections for:

• Real-time documentation retrieval
• Technical guidance and clarification
• Responding confidently to auditor questions
• Managing audit rooms & front/backroom workflows
• Confirming that commitments made to inspectors are compliant and achievable

We act as your technical backbone throughout the inspection.

3. Observations Response & CAPA Writing

If you receive observations (e.g., USFDA Form 483, Warning Letter, WHO Non-compliance, MHRA deficiency), we provide:

Comprehensive CAPA Write-up Support

• Drafting scientifically justified responses
• Writing strong CAPA plans
• Root Cause Analysis (RCA using 5-Why, Fishbone, FMEA)
• Gap closure strategies & timelines
• Impact assessment and risk evaluation
• Effectiveness check planning

Regulatory Response Packages

We prepare complete, audit-style response documents including:

• Corrective actions
• Preventive actions
• Remediation evidence
• Updated SOPs
• Change controls
• Validation/qualification support documents

All written in clear, regulator-friendly language.

4. GMP Compliance Audits

Independent audits of:

• Manufacturing processes
• QMS & documentation
• QC labs & sampling
• HVAC, Water, Utilities & EMS
• Cleaning & disinfection programs
• Validation lifecycle (CSV, cleaning, process, aseptic, equipment)
• Supplier inputs & raw material controls

Reports include Critical / Major / Minor classification with practical CAPAs.

5. Mock Audits (Inspection Simulation)

Simulates foreign regulatory audits under:

• USFDA
• EMA/MHRA
• WHO PQ
• PIC/S
• CDSCO
• Customer or partner audits

Includes live questioning, document review, and immediate coaching.

6. Vendor/Supplier Audits

Qualification audits for:

• API / excipient manufacturers
• Packaging vendors
• Contract manufacturers (CMO/CDMO)
• Third-party laboratories
• Logistics & distribution partners

Includes supplier approval status, GAP report & CAPA plan.

7. Compliance Consulting

• QMS strengthening (Deviation, CAPA, OOS, Change Control)
• Data integrity assessments (ALCOA+)
• Cleaning & EM program design
• Contamination control strategy (CCS)
• SOP revisions & documentation harmonization

Why Choose PrimeGMP for Audit & Regulatory Support?

• Experts with real inspection experience
• Strong writing capability for regulatory submissions & CAPAs
• Deep understanding of sterile and non-sterile GMP systems
• End-to-end support: pre-audit → during audit → post-audit
• Detailed, evidence-based, audit-ready documentation