cGMPs
An Atypical, Abnormal or unplanned incident or event
What is a non-conformance
Compete this sentence - "If it's not Documented..."
What is "it Didn't Happen"
The first toy to be advertised on Television
Who is Mr. Potato Head
Name two of the Five Key Elements of cGMP
What is People, Premises, Processes, Products, Procedures
You should do this if you see evidence of pests in the facility
What is report the sighting to your supervisor immediately
When commenting on a document, this department should always be consulted and involved in the discussions
Who is Quality Assurance
The Rules and Requirements to ensure accurate documentation and traceability
What are Good Documentation Practices
Name the largest type of deer
What is the Moose
One of the biggest concerns that the pharma industry constantly attempts to address
What is Product Safety
A system to ensure that there is stock rotation of all materials (Raws, Components, Finished Goods) in the facility
What is FIFO (First In First Out)
Drug Regulations are codified by 21 CFR part ? and part ? and referred to as the GMPs
What is part 210 and 211
When should information be recorded in a batch record
What is in Real Time
The first women to win a Nobel Prize (1903)
Who is Marie Curie
These are written documents that are to be followed in the execution of various functions
What are Procedures
The section of the Code of Federal Regulations that speaks to Electronic Records, Electronic Signatures, Audit Trails.
What is 21 CFR part 11
The year the GMP regulations were revised to be less ambiguous and finalized
What is 1986
The concept that ensures complete, consistent, and accurate data is attributable, legible, contemporaneously recorded, original or true copy and accurate (ALCOA)
What is Data Integrity
The country that invented Ice Cream
What is China
This department is responsible to verify that all materials and finished product meet quality standards
Who is Quality Assurance
The FDA adopted a systems based approach for drug cGMP inspections. There are six systems defined in the program - Name two
What is the Quality System - Facilities and Equipment - Materials - Production - Packaging and Labeling - Laboratory Control
This site department is responsible for assessing the impact of a change to validated equipment or systems
Who is Validations
Creating, Altering, Recording or Omitting Data so it doesn't represent what actually occurred is call this
What is Falsification of Data
Pure Water has a pH level of around
What is 7.0
They have a critical impact on quality and is responsible for maintaining GMP compliance
Who is Everyone
A drug product is considered this if the manufacturing company does not adhere to cGMP regulations
What is Adulterated