Main goal of cGMP regulations in the manufacture, packaging and distribution of active pharmaceutical ingredients.
What is control?
100
The Agency that issues document 483.
What is the FDA?
100
The number of hours of annual refresher GLP and/or GMP training required per SOP 00-A017.
What are 4 hours?
200
Has overall responsibility for the technical conduct of the study, as well as for the interpretation, analysis, documentation, and reporting of results, and represents the single point of study control.
Who is the Study Director?
200
The footnote D with a circle around it provides the reason for this change in raw data.
What is a date error?
200
Process of determining appropriate controls for chemical processes, or determining the accuracy, precision, robustness, and ruggedness of analytical methods.
What is validation?
200
The average schedule of visits by FDA for routine inspections of a CRO.
What is every two years?
200
Records of routine and non-routine maintenance of equipment are recorded in this.
What is a logbook?
300
The mechanism by which the Study Director controls the study?
What is the protocol?
300
The four steps to correcting an error in the records.
What are:
1. Lining out the error,
2. Documenting the correct entry
3. Documenting the reason for the change
4. Initial and dating the correction?
300
Method or Process to be followed to ensure control over the manufacture of API.
What is the master batch record?
300
A non-routine FDA investigation and visit conducted "for cause".
What is a directed inspection?
300
Documentation of management approval of individuals having been trained to perform specific tasks, whether specified in the SOPs or not, are recorded in this system.
What is PDS, or Personnel Documentation System?
400
Changes in study design without a protocol amendment.
What is a protocol deviation?
400
Actions needed to properly attribute data entry into non-validated electronic spreadsheets, e.g., weight measurements directly into Excel using a wedge system.
What are print and initial/date on the date of data capture.
400
Required analytical result ranges permitted to release an API.
What are specifications?
400
The document 483 is issued to this person(s).
Who is Testing Facility Management?
400
The four types of documentation that are required to support an individual performing tasks on regulated studies or projects.
What are:
1) CV,
2) Educational History,
3)Job Description, &
4) Training records?
500
Activities on a study that do not conform to the GLP regulations.
What are compliance exceptions?
500
Agency term when raw data appears to be fraudulently recorded.
What is "dry labbing"?
500
An API is in this state when an analytical result does not meet the acceptance criteria.
What is an OOS, or Out-of-Specification status?
500
A document issued by the FDA for repeated 483 observations or unacceptable corrective actions.
What is a Warning Letter?
500
The process by which anomalies are investigated thoroughly, root cause(s) determined, corrections of errors completed, and revision of methods/processes implemented to ensure that the same anomaly does not repeat itself.
What is CAPA, or corrective and preventive action?