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Nadia HOUCINATLevel 1

Asked: February 7, 2023In: Quality Assurance

GMP and dispensing materials

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Could someone tell me what the GMP means clearly by the word “dispensing” when talking about material, in the french version, it means delivery. Thanks in advance.

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Nadia HOUCINATLevel 1

Asked: October 8, 2021In: Quality Assurance

Returns Vs Recalls

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Hi all, Could someone help me with definitions and differences for returned products and recalls? Many thanks in advance. Regards.

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Thyagarajan ParthasarathyLevel 1

Asked: September 23, 2021In: Quality Control

Is Airlocks required for MLT and culture handling room?.

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Which guidelines is recommended the airlocks is required for MLT and culture handling room?.

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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 16, 2021In: Quality Assurance

Is it acceptable to simply segregate products of a common therapeutic classification

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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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