International Register of Certificated Auditors IRCA
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Auditing in a fast changing world
Changes in the pharmaceutical industry are making auditing practices and auditor training more global and complex. Auditors must ensure that there is adequate traceability, interface and compliance of each stakeholder’s information about the medicine, while taking into account differing standards of working practice and regulatory interpretations around the world as well as differences in production operations used to manufacture generic and patented medicines. A proliferation of legislation, regulatory publications, standards, guidance documents and expected best practice require auditors to keep their knowledge current to perform effective audits
