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3. 1 DMF PMF and CEP Will your application make reference to any of the following Drug Master File DMF Provide TGA file number if known Plasma Master File PMF Provide name of PMF Certificate of Suitability of Monographs of the European Pharmacopoeia CEP Version of the DMF/PMF/CEP being referenced Name of the company responsible for the DMF/PMF/CEP Modules 1. Tga.gov.au and in Appendices 8 12 and 13 of the ARGPM. Have you provided all the required information Yes No Page 2 of 6 2. 6. 1 1. 6. 2...

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Identify the quality-related variation under section that needs to be filled out.

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Gather all the necessary information regarding the variation, such as the nature of the variation and its impact on quality.

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Who needs quality-related variation under section?

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Manufacturing companies that have quality-related issues and need to document variations in their processes.

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Organizations following quality management systems or standards that require the recording of quality-related variations.

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Regulatory authorities or governing bodies that require companies to submit variations related to quality.

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What is quality-related variation under section?

Quality-related variation under section refers to any changes made to a product or process that could impact the quality or performance of the product.

Who is required to file quality-related variation under section?

Any company or individual who is responsible for making changes to a product or process that could impact its quality or performance is required to file quality-related variation under section.

How to fill out quality-related variation under section?

To fill out quality-related variation under section, one must provide detailed information about the changes made, the reason for the changes, and any potential impacts on the product or process.

What is the purpose of quality-related variation under section?

The purpose of quality-related variation under section is to ensure transparency and accountability in making changes to products or processes that could affect quality or performance.

What information must be reported on quality-related variation under section?

Information that must be reported on quality-related variation under section includes details of the changes made, the reason for the changes, and any potential impacts on the product or process.

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