PRELIM: 4 Flashcards
Validation means _________ or ___________.
rectification or confirmation.
Types of Validation (4)
Analytical method validation
Equipment validation
Cleaning validation
Process validation
Methods should be validated when: (3)
- When they are to be established for routine use.
- When the method is to be changed due to change in conditions.
- Whenever the equivalence between new method and the standard are demonstrated
used for a specific test is suitable for which it is to be carried out.
Analytical method validation
is to provide a high level of documented evidence that the equipment and the process confirm to a standard
Equipment validation
can be defined as a procedure that demonstrates that a process under standard conditions is capable of consistently producing a product that meets the established product specifications.
Validation
The _________ of an analytical method refers to the closeness of values obtained from a series of tests.
precision
The ________ of an analytical method refers to the closeness of agreement between the observed value and the value which is either conventionally a true one or reference one.
accuracy
___________ is established when the same sample is estimated repeatedly by the same analyst using same analytical method within the same laboratory using same instrument and performed within a short period of time.
Repeatability
When the test is repeated on different days by different persons or using different instruments within the same laboratory, the variation is expressed in terms of ____________ ___________.
intermediate precision
is the interval between the upper and lower concentration (amounts) of analyte in the sample
Range
a measure of its capacity to remain unaffected by small, but deliberate variations in method parameters and provides an indication of its reliability during normal usage
Robustness
are two important concepts in analytical chemistry used to assess the sensitivity of an analytical method. They both help to determine the lowest concentration of an analyte that can be reliably detected and quantified, respectively.
Limit of Detection (LOD) and Limit of Quantification (LOQ)
Types of equipment validation: (4)
Installation Qualification (IQ)
Operational Qualification (OQ)
Design Qualification (DQ)
Performance Qualification (PQ)
is the lowest concentration of an analyte that can be reliably distinguished from the background noise with a certain level of confidence at which the presence of the
analyte can be detected, but not necessarily quantified accurately
LOD (limit of detection)
is the lowest concentration of an analyte that can be reliably detected and quantified with acceptable accuracy and precision. It ensures that the measured concentration falls within an acceptable range of uncertainty, allowing for accurate quantification
LOQ (limit of quantification)
ensures that there is no cross contamination in a multi-product manufacturing plant and also prevents microbial contamination
Cleaning validation
Types of contamination to be considered in cleaning validation (4)
- Cross contamination
- Microbial contamination
- Contamination by cleaning or sanitizing agent
- Contamination by other agents
It is done to provide a high degree of assurance that the equipment functions as intended.
Operational Qualification (OQ)
It ensures that all major processing and packing equipment and ancillary systems are in conformity with installation specification, equipment manuals ,schematics
Installation Qualification (IQ)
It is a documented review of the design, at an appropriate stage in the project, for conformance to operational and regulatory
expectation.
Design Qualification (DQ)
It is a documented verification that all aspects of a facility, utility or equipment perform as intended in meeting pre- determined acceptance criteria.
Performance Qualification (PQ)
Important Installation Qualification (IQ) considerations:
- Calibration,preventive maintenance
- Safety features
- Software documentation
- Equipment design features
Important Operational Qualification (OQ) considerations:
- Software procedures
- Raw material specification
- Process operation procedures
- Material handling requirements
