Acronyms
The agency that clears all drugs and medical devices for commercialization in the USA.
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?
It ensures that raw materials and product being manufactured meets criteria.
What is inspection?
These deaths in 1982 led to tamper resistant packaging requirements on OTC drug products.
What are the 'Tylenol murders'?
It's the process for investigating and correcting problems within the quality system.
What is CAPA?
A process used to ensure that equipment used in manufacturing and testing of products and raw materials is working correctly.
What is calibration?
The classification of IV solutions produced at this facility.
What is a combination product?
It ensures that products from different batches don't 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 governs drug manufacture in the USA.
What is 21 CFR 211?
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?
The areas where any pest sightings must be reported to your supervisor.
What are Manufacturing Areas?
The 1938 Food, Drug and Cosmetic Act was passed in response to over 100 deaths by poisonings from using this product.