Auditing Services

‘Audit readiness’ Audits or GMP Compliance Audits

PharmOut’s pharmaceutical cGMP compliance audits / consulting service includes:

  • GMP compliance audits to determine current levels of compliance or audit-readiness to United States FDA, European EMEA and TGA (Australia) standards
  • Preparation of an independent GAP analysis of GMP issues before the auditors arrive, improving your compliance and confidence.
  • Support in getting ready for pre-approval inspections and site audits

Regulatory Inspections / Audits

PharmOut offers:

  • Support and coaching for the proper handling of regulatory auditors and site approval inspections
  • Support in preparing responses and action plans
  • Preparation and implementation of plans to enhance GMP compliance

Post-Audit Remediation Programs

PharmOut services include:

  • Support and coaching in the management of regulatory audit remediation programs
  • Complete turnkey project management of GMP remediation programs
  • Complete turnkey project management of Validation Programs
  • Supplying experienced professional resources to support these activities

Compliance Auditing and Remediation to

  • Australian, Therapeutic Goods Administration (TGA), regulating medicines, medical devices, blood, tissues and chemicals in Australia
  • United States, Food and Drug Administration (FDA), regulating US Food and Drugs.
  • Europe, European Agency for the Evaluation of Medicinal Products (EMEA)

PharmOut specialises in cGMP & Validation compliance in Australia and Asia.