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.
Qualistery – GMP Knowledge Provider Latest Questions
Nadia HOUCINATLevel 1
Hi all, Could someone help me with definitions and differences for returned products and recalls? Many thanks in advance. Regards.
What is important in doing an effectiveness check for CAPA? How do you define your criteria for effectiveness?
Is There Any Method that could be used to define the significance of the health-based Exposure Limit (HBEL) such that there can be broad guidance on the extent of Quality Risk Management (QRM) and control measures required?
Are there any special processing or handling concerns for flexible intravenous (IV) solution bags?
What is the requirement for GxP document retention? Can we choose a single medium (physical or electronic) for records long term preservation to avoid duplication of archived records with the exception of vital records?
Neda ZeinaliLevel 1
Dear all Could you please advise me, is it obligatory to perform cleaning validation only for “multi product facilities” or for both “multi product facilities” and “single product facilities”? Thank you