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What is the most serious issue currently facing the pharmaceutical industry?
What are the 3 most common parenteral routes?
What three parameters does a manufacturing company need to show their product has for the MHRA to issue a Marketing Authorisation (MA)?
What parameter describes the
extent to which bacterial death rate changes with
temperature?
What is the sterility assurance level (SAL) standard for pharmaceutical products?
What genome sequencing technique allows designation of sequence types?
What are the 4 most important features limiting analysis of a sample?
What is the lower and higher specification limit in a "Six Sigma" process?
What are the reference conditions of steam sterilisation?
What is the standard reference dose of gamma-radiation that is needed to sterilize a product?
Name 4 strategies available for the preservation of pharmaceutical products.
What is the impact of changes in preservative availability on efficacy?
Name 2 common applications for gaseous sterilisation?
What are the 3 goals of validation?
What is an Operating Characteristic Curve (OCC)?
Name one advantage and one disadvantage of negative pressure isolators?
The absorbed dose of ionising radiation is measured in which unit?
Which sterilisation method would be most appropriate for a batch of glass bottles containing mineral oil?
What is the minimum necessary time and temperature needed to destroy pyrogens?
What does HACCP stand for in relation to product sterility and quality?
What is the indicator organism employed for demonstrating the integrity of membrane filters?
What is a "special product"?
What preservative group does benzalkonium chloride belong to?
What is the Endotoxin Limit (EL) for an IV or IM injection?
What Endotoxin Unit (EU) do humans begin to develop symptoms?
