Lecture 22 - quality processes Flashcards
what is training vs education
Training to perform a task: for operations where inputs, processes and outputs never change
Education to understand the task: or activities where change can be expected. Active/experience/dialogue
describe blooms level of learning
- create
- evaluate
- analyse
4.apply - understand
- remember
what does a proper process triangle require?
methods, equipment and staff
what is equipment qualification?
Equipment Qualification (EQ) is a formal process that provides documented evidence that an instrument is fit for its intended purpose and kept in a state of maintenance and calibration consistent with its use.
equipment qualification is subdivided into design qualification, installation qualification, operational qualification and performance qualification
what is design qualification?
DQ covers all the procedures prior to the installation of the system in the selected environment. DQ defines the functional and operation specifications of the instrument and details of conscious decisions in the selection of the supplier
what is installation qualification?
IQ covers all the procedures relating to the installation of the instrument in the selected environment. IQ establishes that the instrument is received as designed and specified (in DQ), that it is properly installed in the selected environment, and that the environment is suitable for the operation and use of the instrument)
what is operational qualification?
OQ is the process of demonstrating that an instrument will function according to its operational specification in the selected environment
what is performance qualification?
PQ is defined as the process of demonstrating that an instrument consistently performs according to the specification appropriate for routine use
what is validaton?
Validation is the process of collecting documentary evidence demonstrating that a procedure, process, method or activity carried out in manufacture or testing will consistently produce the expected results.
Examples of validation could be:
Cleaning validation (esp cytotoxics and tablet counters/surfaces)
Process validation (ie autoclave load/cycle)
Analytical method validation
Computer system validation
Questionnaires
what is specificity?
Specificity is the ability to assess unequivocally the analyte in the presence of components which may be expected to be present (impurities, degradants, matrix, etc.)
Example calculation: measure paracetamol in effervescent paracetamol/caffeine tablets by UV
what is accuracy ?
The accuracy of an analytical procedure expresses the closeness of agreement between the value which is accepted either as a conventional true value or an accepted reference value and the value found.
Use the test method to analyse “control” samples
Samples of analyte prepared in the matrix to be studied of known concentration
what is precision and robustness?
Precision: The precision of an analytical procedure expresses the closeness of agreement (degree of scatter) between a series of measurements obtained from multiple sampling
Robustness: robustness of an analytical procedure is a measure of it’s capacity to remain unaffected by small, but deliberate variations in method parameters
what is range/ LOD/ LOQ
Range of acceptable concentrations of the assay
Detectors have a max and min range, so some concentrations will be outside that range.
LOD: detection limit is the lowest amount of analyte in a sample which can be detected but not necessarily quantitated as an exact value
LOQ: quantification limit is the lowest amount of analyte that can be determined with acceptable precision
