GMP Compliance Audits

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

CiPharma has several consultants who have years of experience as auditors for PIC/S and the FDA. 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.

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.

CiPharma 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 organizations
  • Pharmacies
  • Research institutions