Quality Control Basics
This is the term for testing raw materials to ensure they meet specifications before production.
What is incoming material testing
If it's not documented, then...
What is "It didn't happen"?
This analytical tool separates components of a sample based on their size, charge, or affinity.
What is chromatography?
Name the QC document that lists all of our release specifications
What is the monograph?
Define: UDF
What is unidirectional air flow
This document outlines the specific procedures to follow during testing.
What is a Standard Operating Procedure (SOP)?
Controlled document used as a record to maintain a sequential and detailed record of activities, events, or observations related to specific processes, equipment, or systems. Can be paper or electronic
What is a logbook?
This technique measures the concentration of proteins in a vaccine sample using light absorption.
What is UV-Vis spectrophotometry?
When a result doesn't meet specification or is not typical, it is......
What is out of specification or atypical?
The level and type (atypical or not) of microorganism present in raw materials, media, production intermediates and final products.
What is bioburden
This is the agency responsible for regulating vaccines in the United States.
What is the FDA (Food and Drug Administration)?
What does ALCOA stand for?
What is Attributable, Legible, Contemporaneous, Original, Accurate.
This method evaluates the amount of residual water in lyophilized final powder
What is the Karl Fischer method?
The number of data points needed to set an action limit
What are 30 data points?
This signals a potential drift from normal operating conditions. This may not require action but may need to be followed up and monitored more closely than usual.
What is Alert Limit
A set of parameters that dictate whether an assay is valid
What are system suitability parameters or assay validity criteria?
Electronic system used to execute Quality Control testing.
What is the Laboratory Execution System?
This method is used to evaluate the S5 Fraction process step in QS-21. The manufacturing process cannot move forward without it.
What is Concentration by MS (Mass Spectrometry)
If no rabbit showed an individual rise in temperature of 0.5C or more above its respective control temperature, the product meets.....
What is absence of pyrogens?
Environmental/utility monitoring parameters for air include 2 types of particles
What are viable and non-viable particles
This is the name for the process that ensures a testing method consistently produces accurate results over time.
What is method validation?
Document generated by Quality Control that lists all the test results associated with final powder
What is a certificate of analysis?
Name the MPL methods that involve the use of a humidity-controlled room for weighing out of MPL Final powder
What is Hexosamine, Phosphorus and Triethylamine (TEA)?
Evaluation of MPL by Congeners method: Name the upper spec limit of the Heptaacyl make up of MPL (looking for a percentage)
What is less than 0.5%?
Name 4 of the 5 data points generated for Hamilton's water systems (WFI and LPW).
What are bioburden, endotoxin, TOC, Conductivity, and Nitrates.