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Nadia HOUCINATLevel 1

Asked: February 7, 2023In: Quality Assurance

GMP and dispensing materials

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.

Nadia HOUCINATLevel 1

Asked: October 8, 2021In: Quality Assurance

Returns Vs Recalls

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

Thyagarajan ParthasarathyLevel 1

Asked: September 23, 2021In: Quality Control

Is Airlocks required for MLT and culture handling room?.

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

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 16, 2021In: Quality Assurance

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

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 13, 2021In: Analytics

What responsibility do contract givers have to contract manufacturers in relation to data to support a HBEL assessment?

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?

Load More Questions

GMP and dispensing materials

Returns Vs Recalls

Is Airlocks required for MLT and culture handling room?.

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?

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

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?

What responsibility do contract givers have to contract manufacturers in relation to data to support a HBEL assessment?

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?

tablet hardness

What is Data Governance?

What is data life cycle?

Yan Kugel

Qualistery

Shashi Ravi Suman Rudrangi, RPh

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