Show:
Laboratory
Production
Quality Management
Qualification & Validation
Data Integrity and GDP
100
T / F The European Pharmacopeia is part of the EU GMP
What is False, it is a different document
100
The abbreviation "API" stands for this
What is Active Pharmaceutical Ingredient
100
In a GMP record a pH value is changed from 7.82 to 7.40, what does this correction require
What is signature, date and an explanation
100
The acronym VMP stands for this
What is Validation Master Plan
100
When the batch record must be completed.
What is At the time it happens or contemporaneously
200
The reason why it is impossible to prove quality on an entire batch by laboratory testing
What is testing is destructive so on a portion of the batch can be tested
200
Batch records are normally reviewed by which function
What is what is Production and Quality Unit (QA)
200
T/F It is possible to make a small change in a written manufacturing method without approval from the Quality Unit (QA)
What is False, all changes to written procedures must be reviewed and approved by Quality
200
The definition of Calibration
What is To compare the reading from a measuring instrument with an outside, independent standard
200
T/F it is allowed to change electronic raw data
What is true as long as there is traceability
300
T/F entries into logbooks can be recorded without signatures or initials when it is clearly noted to whom the logbook belongs to
What is False, signatures or initials are required for all entries
300
The definition: "Any substance used in the production of a medicinal product, excluding packaging material" is identified as
What is a starting or "raw" material
300
A 15 liter container has been used instead of the 10 liter container that was specified in the batch record, how should this be treated?
What is file a deviation report, any discrepancy from the written specifications is a deviation
300
T/F It is necessary to validate analytical methods used only for IPC (In Process Control)
What is True, all methods must be validated
300
The reason correction fluid is not allowed in a GMP Environment
What is corrections shall not hide or destroy the initial entry
400
The only time OOS (Out of Spec) results can be invalidated
What is when the investigation leads to a proven documented laboratory error.
400
three conditions that need to be controlled in the warehouse where finished and released product is stored
What are temperature, humidity, cleanliness, and lighting
400
T/F When archiving a GMP record it must be protected so that the information is readable during the whole retention period
What is True
400
The IQ (Installation Qualification) & OQ (Operational Qualification) can be performed as a combined activity
What is True
400
The abbreviation ALCOA
What is attributable, Legible, Contemporaneous, Original, Accurate
500
The reason it is important to analyze microbiological samples within a short timeframe
What is because microorganisms can continue to grow or any preservative in the sample can kill them
500
The purpose of having higher pressure in production rooms compared to surrounding room/areas
What is to reduce the risk of contamination
500
The reason a pharmaceutical company must have a Quality Unit (QA) that is independent from Production
What is to ensure that there is proper balance between quality and economic factors in the decisions taken
500
A maintenance procedure states that the gasket should be replaced when the equipment starts to leak, is this in accordance with GMP and why?
What is No, maintenance should be preventive
500
It is the common way to make sure only authorized people enter data in computerized systems
What is a username and password