Clean Room Quiz 4

Clean Room Quiz 4

Clean Room Quiz 4 Question: What is the purpose of the airflow test? Answer: The purpose of the airflow test is to measure airflow velocity, uniformity, and supply air volume flow rate in cleanrooms and clean zones. This includes measuring velocity distribution in unidirectional airflow areas and supply air volume flow rate in non-unidirectional areas. … Read more

Change Control Quiz

Change Control Quiz Question: What is change control in the pharmaceutical industry, and why is it considered a critical part of quality management? Answer: Change control in the pharmaceutical industry is a systematic approach to managing product, process, or system changes. It is considered a critical part of quality management because it ensures that changes … Read more

Production Quiz 03

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Production Quiz 03 Question: What is capping in the context of tablet manufacturing? Answer: Capping occurs when the upper or lower segment of a tablet separates horizontally, either partially or completely, from the main body of the tablet during ejection from the tablet press or subsequent handling. Question: What is the typical reason behind capping … Read more

Stability (ICH Q1A) Quiz 7

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Stability (ICH) Quiz 7 Q: What are the requirements regarding the number of primary batches for formal stability studies of a drug substance? A: Formal stability studies necessitate data from at least three primary batches of the drug substance. Q: What criteria must the primary batches meet for inclusion in formal stability studies? A: The … Read more

Stability (ICH Q1A) Quiz 1

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Stability (ICH Q1A) Quiz 1 Q: What is the purpose of the revised ICH Q1A guideline mentioned in the text? A: The purpose of the revised guideline, based on the ICH Q1A guideline, is to establish the stability data package necessary for the registration application of a new drug substance or drug product across the … Read more

Production Quiz 02

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Production Quiz 02 Question: What is mottling, and what factors contribute to this defect in tablets? Answer: Mottling is a tablet defect that can be caused by colored drugs (Excipient-related), improper mixing of granular material (Process-related), dirt in the granular material, or the use of oily lubricant, leading to oil spots. Answer: How does the … Read more

Production Quiz 01

Clean Room Quiz 4

Production Quiz 01 Question: What are the challenges faced in tablet manufacturing? Answer: The challenges in tablet manufacturing include visual and functional defects, which have increased due to complexities in tablet presses and higher quality demands. Question: Why have advancements and innovations in tablet manufacture not decreased the production problems? Answer: The production problems have … Read more