PRELIM 02 - Concepts in Pharmaceutical Quality Assurance Flashcards
Refers to the action of proving that any procedure, process, equipment, material, activity, or system actually and consistently leads to the expected results
Validation
This team’s responsibility is to identify needs, develop protocols, and conduct validation/qualification
Validation team
Is a high-level document that establishes an umbrella validation plan for the entire product
Validation master plan (VMP)
Refers to the process of establishing documented evidence that a process used in manufacture does what it purports to do
Prospective validation
Refers to validation carried during routine production of products intended for sale
Concurrent validation
Refers to validation of a process for a product that has been marketed based upon accumulated manufacturing
Retrospective validation
Refers to repeated validation of an approved process to ensure continued compliance with established requirements
Revalidation
Refers to the action of proving and documenting that premises, systems, and equipment are properly installed
Qualification
Validation that demonstrates that an analytical procedure is suitable for its intended purpose
Analytical method validation
The ability to assess unequivocally the analyte in the presence of components which may be expected to be present
Specificity
The ability to obtain test results which are directly proportional to the concentration of analyte in the sample
Linearity
The interval between the upper and lower concentration of analyte in the sample
Range
Expresses the closeness of agreement between the value which is accepted either as a conventional true value or an accepted reference value
Accuracy/Trueness
Expresses the closeness of agreement between a series of measurements obtained from multiple sampling of the same homogenous sample
Precision
Expresses the precision under the same operating conditions over a short interval of time
Repeatability/Intra-assay precision
Expresses within-laboratories variations: different days, different analysts, different equipment, etc.
Intermediate precision
Expresses the precision between laboratories (collaborative studies, usually applied to standardization of methodology)
Reproducibility
A limit that refers to the lowest amount of analyte in a sample which can be detected but not necessarily quantitated as an exact value
Detection limit
A measure of the capacity to remain unaffected by small, but deliberate variations in method parameters
Robustness
Type of testing based on the concept that the equipment, electronics, analytical operations and samples to be analyzed constitute an integral system that can be evaluated as such
System suitability testing
Refers to the actions taken to remove a product from the market
Product recall
An NSAID and a prescription painkiller that was recalled in 2004 due to risk of deadly heart attacks
Rofecoxib (Vioxx)
An alert issued within 24 hours after the FDA director general approves a product recall order
Public health alert
Situation in which there is a reasonable probability that the use or exposure to the product will cause serious adverse health consequences or death (Recall classification)
Class 1
