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cGMP Audit and Assessment

IQS Consulting can support your audit needs by conducting cGMP audits of your API, component and excipient suppliers, cGMP audits of contract manufacturing and testing organizations, or site regulatory inspection preparation assessments and mock audits.

New approach: An effective auditor will apply the right guidelines or standards to evaluate an operation in a thorough and efficient manner. Compliance gaps are identified, prioritized and, if requested, recommendations are provided by the auditor. Typically, the audit is closed and the GMP auditor moves on. IQS Consulting’s approach is to ensure the audit structure offers a measure of control and more than just a “snapshot in time”. Contact us to understand our approach and a possible fit for your operation.

Service goal: Maximize supply chain reliability while reducing supplier oversight costs.