GMP Gap Analysis & Mock Audits

GMP Gap Analysis & Mock Audits

A professional GMP Gap Analysis is the first line of defense for any pharmaceutical facility aiming for US FDA, EMA, or WHO compliance. QualyInc performs exhaustive inspections modeled directly on international agency standards.

We evaluate all operational aspects including sterile area design, computerized automation logic, analytical instrumentation records, raw material warehousing, and staff sanitation policies. By identifying weaknesses prior to regulatory audits, we help you fix non-conformances safely and systematically.

Key Deliverables

  • Comprehensive Gap Report: Detailed list of system deviations mapped against CFR Part 210/211 and EU Volume 4 guidelines.
  • Data Integrity Assessment: Detailed audit trail reviews for spectrophotometers, chromatography software (Empower), and LIMS database records.
  • Layout & Flow Qualification: Assessment of personnel movements, material streams, and pressure differentials in grade-A sterile formulation units.
  • Actionable CAPA Roadmap: Recommended corrective and preventive action steps categorized by severity (Critical, Major, Minor).

Need a customized scope proposal?

Our consulting team is based locally in Hyderabad and can perform a baseline visit within 48 hours.

Request a Custom Proposal