GMP Compliance Audits

GMP Compliance Audits

GMP compliance audits are often referred to as ‘GMP Mock Audits’, ‘Pre-audit Audits’, ‘GMP Gap Analysis’ or ‘Pre-regulatory audits’, a GMP Compliance Audit is an audit or an inspection conducted by someone external to your organisation with the purpose of discovering GMP deficiencies.

PharmOut has several consultants who have years of experience as auditors for the Australian TGA. These consultants will conduct a GMP Compliance Audit as if they were doing so for a regulatory body, but with friendly advice on how to fix your GMP problems. We can help with a road map on how to remediate and enhance your facility and QMS/PQS to ensure compliance. We have pharmaceutical engineers and architects experienced in GMP related remediation projects to support our GMP / QA consultants in offering cost and time line advice.

If you are exporting product to multiple countries that use different regulatory frameworks, we can help you achieve compliance in a practical way, rather than drowning yourself in paperwork.

PharmOut offers GMP Compliance Audits tailored for:

  • Pharmaceutical manufacturers, sponsors and industry suppliers
  • Complementary medicine manufacturers, sponsors and industry suppliers
  • Medical Device manufacturers or sponsors
  • Blood and Tissue organisations
  • Pharmacies
  • Research institutions

Related services include GMP audits of suppliers and Audit findings response development.

More information

If you would like a quote or would like to ask questions, please contact us.