Pharmaceutical companies must re-audit active pharmaceutical ingredient producers for GMP compliance every three years. These mandatory re-audits confirm adherence to current standards and allow for ongoing improvements, risk identification, and necessary corrective actions.
At blue our services include the timely re-audit scheduling of your suppliers, securing the optimum re-audit date and preparing the audit comprehensively in order to reduce delays in receiving the re-audit report on time.
During a mandatory GMP re-audit, auditors systematically review the organization's procedures, records, and operations under consideration of the results of the previous audit. They assess the effectiveness of internal controls, risk management practices, and adherence to regulatory requirements. The findings from these re-audits provide valuable insights for enhancing operational efficiencies and strengthening internal controls. Manufacturers can prepare for mandatory re-audits by maintaining up-to-date documentation and conducting regular internal audits.
