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Manufacturing

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jenyfallLevel 2

Asked: July 20, 2024In: Manufacturing

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QualisteryLevel 2

Asked: September 17, 2021In: Manufacturing, Quality Assurance

How many containers of each component from each shipment must a firm sample and test to comply with the CGMP requirements for identity testing? Do the CGMPs permit the identity test on a pooled, or composite, sample of multiple containers?

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QualisteryLevel 2

Asked: September 15, 2021In: Manufacturing, Quality Assurance

What are the Specs and Requirements for conducting visual inspection as per Q&A 7?

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QualisteryLevel 2

Asked: September 13, 2021In: Commercial, Manufacturing

Is analytical testing required at product changeover, on equipment in shared facilities, following completion of cleaning validation?

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QualisteryLevel 2

Asked: September 12, 2021In: Commercial, Manufacturing

Does FDA require or recommend any special precautions or controls over the manufacturing of animal-derived drug ingredients to prevent contamination?

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QualisteryLevel 2

Asked: September 11, 2021In: Manufacturing

What are FDA’s primary concerns about pathogenic agent contamination of animal-derived drug ingredients?

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QualisteryLevel 2

Asked: September 9, 2021In: Manufacturing

What manufacturing contamination risks are presented by the different pathogenic agents?

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QualisteryLevel 2

Asked: September 6, 2021In: Manufacturing

How should manufacturers use the HBELs (Health-Based Exposure Limits)?

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QualisteryLevel 2

Asked: September 5, 2021In: Manufacturing

What are some ways to minimize pathogenic agent contamination in incoming animal-derived raw material?

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QualisteryLevel 2

Asked: September 4, 2021In: Manufacturing

Are there control measures for minimizing pathogenic agent contamination in animal-derived drug ingredient manufacturing facilities?

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