Acronyms
The agency that clears all medical devices for commercialization.
What is the FDA (Food and Drug Administration)?
This is the documentation that shows equipment can do what we say it can do.
What is validation?
What is training?
An attribute of the work environment that reduces potential contamination of the product.
What is cleanliness?
The book by Upton Sinclair that made people aware of food safety issues.
What is The Jungle?
It's what GMP stands for.
What is Good Manufacturing Practices?
This shows evidence that our product is designed to meet end user needs.
What are Design Controls?
It's a report of a possible failure of a device, labeling or packaging to meet any any of its specifications.
What is a complaint?
What is inspection?
These deaths in 1982 led to tamper resistant packaging.
What are the 'Tylenol murders'?
What is CAPA?
A process used to ensure that inspection devices function properly and are not worn.
What is calibration?
These are the two acceptable colors of ink to use on GMP documentation.
What are blue and black?
It ensures that no products get mixed up during the manufacturing process.
What is line clearance?
Two recalls of this food in recent years led to lots of kids not having their favorite lunch.
What is peanut butter?
It's the regulation that mandates the implementation of Good Manufacturing Practices for medical devices.
What is QSR?
A system used to ensure a batch of products can be traced back to the original materials.
What is material traceability?
GMP Regulations ensure that our products have these two qualities.
What are safe and effective?
Seven years, or the life of the product.
What is the retention period required for our products?
The 1938 Food, Drug and Cosmetic Act was passed in response to over 100 deaths by poisonings from using this product.