PharmOut provides GMP Compliance Auditing and Remediation to the level of:
- 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)
The types of auditing services available:
‘Audit Readiness’ Audits, GMP Compliance Audits and Regulatory Inspections
If you’ve got an upcoming audit and you’re concerned about the GMP ‘health’ of your facility and quality systems, it’s wise to get a pre-audit performed to detect and solve problems before they’re picked up by an official auditor – otherwise you might end up with a nasty shock when the audit report lands on your desk! We can provide:
- GMP compliance audits to determine current levels of compliance or audit-readiness to United States FDA, European EMEA and TGA standards
- Audits for research institutions – covering GCP and GLP.
- Audits for 21 CFR Part 11 / Annex 11 Compliance
- Vendor Assurance/Supplier Audits
- 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
- Support and coaching for the proper handling of regulatory auditors and site approval inspections
- Support in preparing responses to audits and action plans
- Preparation and implementation of plans to enhance GMP compliance
Post-Audit Remediation Programs
If you’ve already had an audit and the result has been a bit of a kick in the teeth, it can be overwhelming to even know how to respond much less where to start improvements. PharmOut has assisted many companies with audit remediation programs and we can provide:
- 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
If you would like us to help with compliance issues on your site, want to organise pre-audit or post-audit remediation programs, or just have some questions you want to ask, contact us here.