Quality Control Flashcards
Define manufacturing quality
Strict and consistent adherence to measurable and verifiable standards to achieve uniformity of products that satisfies specific customer or user requirements
Define ISO quality
Ability to satisfy state or implied needs set out by regulatory body
Define pharmaceutical quality
Procedures undertaken to ensure identity and purity of a particular pharmaceutical
What is quality assurance?
A wide concept that covers things that influence quality of a manufacturing product
What is good manufacturing practice?
Ensuring that pharmaceutical products are produced and controlled in a way that meets quality standards
What does quality control do?
samples, tests and specifies materials at each level of manufacturing. It determines if everything used meets the requirements
What questions must be asked when determining quality control?
Is it:
- the right product?
- the right strength?
- free from contamination?
- deteriorated?
- in the right container?
- correctly labelled?
- correctly sealed, packed and protected?
What are counterfeit medicines?
Fake medicines that may be contaminated or contain the wrong/no API.
They are generally manufactured under poor standards of GMP compliance
When should quality be tested?
At different stages of manufacture
What does QC aim to do?
Prevent defects rather than detect them
Which analytical methods are used in QC?
Accuracy Precision Specificity Detection limit Quantitation limit Linearity Range
What is the detection limit?
The lowest amount that can be detected
What is the quantification limit?
The largest amount that can be detected
What is the range?
The interval between the lower and upper concentrations of the analyte
What is linearity?
The ability to obtain data directly proportional to the concentration of the analyte
