Sketch and label process flow diagrams illustrating typical biopharmaceutical unit operations for the sequential manufacture of both drug substances and drug products. (20%)
pharmacology
Description
Assignment Descriptor
Q-1: Sketch
and label process flow diagrams illustrating typical biopharmaceutical unit
operations for the sequential manufacture of both drug substances and drug
products. (20%)
Q-2: Describe
process support and utility systems encountered on a typical biopharmaceutical
facility. (15%)
Q-3: Sketch
and describe the configuration of a hypothetical cleanroom environment for
aseptic processing (e.g. for vial filling operations). (15%)
Q-4: Describe
the similarities and differences between pharmacopeia grade purified water
(PUW) and water for injection (WFI). (15%)
Q-5: Describe
the sequence for the determination of manufacturing logistics for a typical
biopharmaceutical product. (15%)
Q-6: Sketch
and describe a hypothetical site master plan layout to incorporate drug
substance, drug product and finished pharmaceutical activities. (20%)
