Quality control Flashcards
In manufacturing, what is the definition of quality?
Strict and consistent adherence to measurable and verifiable standards to achieve uniformity of output that satisfies specific customer or user requirements
In terms of ISO standards, what is the definition of quality?
The totality of features and characteristics of a product or service that bears its ability to satisfy stated or implied needs
What is meant by quality assurance?
It’s a wide range concept covering all matters that influence the quality of a pharmaceutical product
What is meant by good manufacturing practice?
GMP ensures that pharmaceutical products are produced and controlled to meet appropriate quality standards
What is quality control?
A process dedicated to sample, test and specify materials at each level of manufacturing. It determines if materials/products meet the requirements
What are counterfeit medicines?
Fake medicines. They are illegal and may be contain the wrong or no API
Raw materials are not examined in the quality control department. True or false?
False - they are examined to may sure they meet the appropriate specifications
Are partial/intermediate products tested in the quality control department?
Yes - to correct/adjust manufacturing processes
What is meant by specificity?
The ability to register only the desired analyte, while all other components in the formulation do not influence the results
What is meant by sensitivity?
The smallest absolute amount of change in analyte that can be detected by a measurement
A batch should be prepared for each batch of a substance or product. True or false?
True
