‘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
- 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.