GxP Compliance Auditing

It is a systematic, independent and documented process for obtaining and objectively evaluating evidence to determine the extent to which audit criteria are met. The goal is to confirm that the quality system of your supplier is in place and effective to guarantee the quality of services and products.

Our audit processes are highly structured with a built-in qualitative or quantitative rating system. All aspects of your quality management program including GxP requirements can be assessed. At the initial consultation, we form an accurate understanding of your business, what you require and what needs to be done. So our intervention is tailored to your specific needs.

Mivado Globalperformance can help you build a successful, resilience business in compliance with GxP requirements. Don’t worry! Our auditors’ in-depth knowledge of domestic and international regulations, and their hands-on GxP experience, can take the uncertainty out of GMP compliance.

Mivado GlobalPerformance provides the following audit activities:

Quality System

  • Review Quality Systems components,
  • Evaluate suppliers of raw materials, packaging and labeling components, and distribution of clinical trial materials
  • Review CAPA programs
  • Method validations (analytical and microbiological)
  • Review submitted method validations
  • Review Validation Package

Inspection Readiness

  • Evaluate the preparedness of manufacturing facilities
  • Assess readiness of site personnel
  • Prepare personnel for inspector interviews
  • Review Chemistry, Manufacturing and Control (CMC) submissions
  • Assess technical transfer for manufacturing and test methods
  • Review labeling for compliance

Facility Compliance

  • Facility, Utilities, Equipment & Systems Audit
  • GMP Documentation Review
  • Laboratory, Methods & Specifications
  • CAPA programs (Corrective Action/ Preventive Action)
  • Review Validation Lifecycle
  • Assess Vendor Certification Programs
  • Evaluate data integrity

Vendor GMP Audits

  • Perform routine and qualification audits
  • Laboratories and suppliers of drug substance; raw materials; and packaging components
  • Inspect facilities and equipment
  • Assess qualification and training of personnel
  • Review organization structure
  • Assess Quality Systems and CGMP compliance

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