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WorksheetsQuality Assurance in GLP-1
Total questions: 10
Worksheet time: 5mins
What is the main reason for the importance of quality risk management (QRM) principles in the manufacture of biological active substances and finished products?
To minimize variability and reduce the opportunity for contamination and cross-contamination
To maximize variability and increase the opportunity for contamination
To maximize variability and reduce the opportunity for contamination and cross-contamination
To minimize variability and increase the opportunity for contamination
What should be considered as part of ensuring product safety for personnel responsible for production and control?
Regular health checks and vaccination with appropriate specific vaccines
No consideration for the health status of personnel
No training in cleaning and disinfection procedures
What should be performed on each batch of received starting materials prior to release?
A visual inspection
An identity test or equivalent
A smell test
A taste test
What should be used for the routine addition of gases, media, acids, alkalis, and so on to fermenters or bioreactors?
In-line microbial-permeable filters
In-line microbial-resistant filters
In-line microbial-retentive filters
In-line microbial-absorbent filters
During the early stages of production, what may be used to help prevent inadvertent microbial contamination or to reduce the bioburden of living tissues and cells?
Antibiotics
Antivirals
Antifungals
Antiparasitics
What should be in place for the decision to use a facility or filling line for campaign manufacture?
No justification for the decision
No need for any risk approach
A systematic risk approach for each product
A random selection of products for campaign manufacture
What should be removed from the manufacturing area or sent to the bio-waste system in a safe manner after campaign production?
Materials transferred by a validated procedure
Waste
Products
Materials transferred by a non-validated procedure
What is the recommended method for routine addition of gases, media, acids, alkalis, etc. to fermenters or bioreactors?
Using in-line microbial-permeable filters
Using in-line microbial-resistant filters
Using in-line microbial-retentive filters
Using in-line microbial-absorbent filters
What system should be implemented to prevent the unwanted drift of genetic properties?
System based on the production of biological products obtained by radiation
System based on the production of biological products obtained by chemical and physical techniques
System based on the production of biological products obtained by microbial culture, cell culture, or propagation in embryos and animals
System based on the production of biological products obtained by gas
Why are quality risk management (QRM) principles important in the manufacture of biological active substances and finished products?
To maximize variability and reduce the opportunity for contamination and cross-contamination
To minimize variability and reduce the opportunity for contamination and cross-contamination
To minimize variability and increase the opportunity for contamination
To maximize variability and increase the opportunity for contamination
