Quality Assurance in GLP-1

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