Audit - 02 Understanding Worldwide Regulatory Requirements

Audit Manual 02 - Understanding Worldwide Regulatory Requirements

Determine the appropriate Worldwide Regulatory GMP requirements for a site or product being audited. Identify which Regulatory Agencies govern specific regions of the world. Use a range of information tools in support of a manufactured product distributed

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Audit 02 - Understanding Worldwide Regulatory Requirements

The purpose of this training unit is to provide information regarding Worldwide Regulatory Agencies and the regulations that they enforce with respect to manufacturing sites and suppliers.



Depending upon where pharmaceutical sites are located throughout the world and where their products are distributed/marketed each site will need to comply with regulations enforceable by different regulatory agencies. These regulatory agencies are determined by where the drug is manufactured, distributed and marketed. The regulatory agency will evaluate all sites that take part in the manufacturer of the drug product. This oversight includes the range of initial manufacturing steps of the raw materials/APIs to the final packaging sites (primary and secondary). Different regulations are applied depending on the step in the manufacturing process.



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