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Manufacturing

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18Answers

11Questions

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?

QualisteryLevel 2

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

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

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?

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?

QualisteryLevel 2

Asked: September 11, 2021In: Manufacturing

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

QualisteryLevel 2

Asked: September 9, 2021In: Manufacturing

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

QualisteryLevel 2

Asked: September 6, 2021In: Manufacturing

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

QualisteryLevel 2

Asked: September 5, 2021In: Manufacturing

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

QualisteryLevel 2

Asked: September 4, 2021In: Manufacturing

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

Anonymous

Asked: August 13, 2021In: Manufacturing

Are (HBELs) Health-Based Exposure Limits required for all medicinal products?

Load More Questions

Manufacturing

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?

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

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

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

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

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

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

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

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

Are (HBELs) Health-Based Exposure Limits required for all medicinal products?

tablet hardness

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Yan Kugel

Qualistery

Shashi Ravi Suman Rudrangi, RPh

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Manufacturing

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