QA-QC EXAM 2 Latest Questions with Correct Answers.
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Course
QA-QC
Institution
QA-QC
QA-QC EXAM2LatestQuestionswithCorrect
Answers.
Q1. What is not always a requirement for cGMP compliant sampling? - Correct Answers
Samples must be stored at low temperatures.
Q1. What is always a requirement for cGMP compliant sampling? - Correct Answers -
Sampling plans and methods must be wr...
QA-QC EXAM 2 Latest Questions with Correct
Answers.
Q1. What is not always a requirement for cGMP compliant sampling? - Correct Answers
Samples must be stored at low temperatures.
Q1. What is always a requirement for cGMP compliant sampling? - Correct Answers -
Sampling plans and methods must be written, defined, and pre-approved.
- Samples must accurately portray the quality attributes of a drug product lot.
- Sampling plans must be based on appropriate statistical criteria
- Samples obtained must be properly identified and handled.
Q1. Which is not an In-process control test used to monitor the progress of protein
production during fermentation? - Correct Answers Gene copy number
Q1. Which is an In-process control test used to monitor the progress of protein production
during fermentation? - Correct Answers - Concentration of biologic
- Presence of misfolded proteins
- Presence of chemicals used to clean the bioreactor
- Endotoxin levels
Q1. In the sampling table shown in slide 35, for a lot size of 660, __________ units should
be obtained and tested for conformance to specifications. - Correct Answers 32 Units
Q1. During bioprocess, the temperature sensors (probes) are dipped in the fermentation
culture inside the bioreactor, signal from the sensors read by a computer, and the
temperature of the heating blanket gets automatically adjusted.
The temperature measurement by the sensor is an example of... - Correct Answers In-line
measurement
Q1. What is not a main job responsibility of the QC's group? - Correct Answers Checking
the adherence of process technician to batch record SOPs.
Q1. What is a main job responsibility of the QC's group? - Correct Answers - Analytical
testing of raw materials against specifications before use by the production group.
- Testing of drug products against specifications before release.
- Provide analytical support for process validation and in-process test.
- Environmental monitoring for viables and non-viables.
Q1. What does not apply to raw materials or raw material testing? - Correct Answers Full
testing against the CofA should be conducted on all raw materials.
Q1. What does apply to raw materials or raw material testing? - Correct Answers -
Criticality of materials and tests differ for different raw materials depending on their
intended use.
, - Raw materials must be identified, quarantined, their identity tested by specific assays,
and released by QC and QA.
- Quality requirements for raw materials are met somewhat differently in production of pre-
clinical, clinical batches, and manufacturing of licensed products.
- If the raw material is microbiologically sensitive, it may be prudent to sample every
container regardless of lot size.
- Certificates of analysis should accompany every lot of delivered raw material.
Q1. What is not a process control variable in the downstream cell harvesting processes
that could impact product quality and yield? - Correct Answers Bioreactor cleaning
reagents.
Q1. What is a process control variable in the downstream cell harvesting processes that
could impact product quality and yield? - Correct Answers - Filtration backpressure.
- Filtration temperature.
- pH of chromatography mobile phase.
- Centrifugation speed.
Q1. 45 drums of bulk raw material were delivered to your manufacturing company. As the
QC analyst assigned to handle the delivered material, what is the minimum number of
drums that you should sample and test for attributes like impurities or water content? -
Correct Answers 8 drums
√n + 1
Q1. In the manufacturing of small molecule drugs, what would be considered as an
impurity rather than a contaminant? - Correct Answers incompletely synthesized API
Q1. In the manufacturing of small molecule drugs, what would not be considered as an
impurity rather than a contaminant? - Correct Answers - equipment lubricants
- microbes
- endotoxins
- dust particles
- an inorganic catalyst.
Q1. What does not apply to specifications for release of finish drug products? - Correct
Answers Acceptance criteria should be changed if test results don't conform to
specifications.
Q1. What does apply to specifications for release of finish drug products? - Correct
Answers - Many analytical procedures that are part of specifications are found in the US
Pharmacopeia.
- Specifications consist of test procedures.
- Release specifications are approved by regulatory agency as conditions for marketing
approval.
- Specifications include rejection criteria for certain attributes.
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