validation

studied byStudied by 5 people
5.0(1)
Get a hint
Hint

validation

1 / 86

encourage image

There's no tags or description

Looks like no one added any tags here yet for you.

87 Terms

1

validation

the term widely used in the pharmaceutical industry

New cards
2

valid

means can be justified or legally defined

New cards
3

validation

is demonstration and documenting that something does what is supposed to do

New cards
4

validation

a full detailed documentation that all processes and procedures are functioning in the manner that they are designed for

New cards
5

validation

is a documented act of proving that any procedure, process, equipment, material, activity, or system actually leads to the expected result

New cards
6

method validation

process of proving that an analytical method is acceptable for its intended purpose

New cards
7

analytical procedures

_________________ must be shown to be acceptable for their intended use and must provide accurate and reliable results at every stage of development

New cards
8

evidence

validation of analytical test methods provides ________________ that systems and methods are suitable for the intended use

New cards
9

accuracy, sensitivity, specificity, reproducibility

the _________, ____________, __________, and ________________ of test methods employed by the firm shall be established and documented

New cards
10

purpose

there should be evidence that validated analytical procedures meet their ___________ through its life cycle

New cards
11

validation

the process by which it is established, by laboratory studies, that the performance characteristics of the procedure meet the requirements for the intended analytical applications

New cards
12

alternative method or procedure

is defined as any method or procedure other than the compendial method of procedure for the article in question

New cards
13

fully validated

the alternative method and procedure must be ____________ and must produce comparable results to the compendial method or procedure within allowable limits in a case by case basis

New cards
14

controlled, monitored

the FDA has strict guidelines for process validation in manufacturing because the process has to be _____________ and ___________ throughout all stages of manufacturing

New cards
15

efficacy, safety, cleanliness, sterility

validation is necessary if a company wants its product to have enough ____________, ______________, ______________, or ___________

New cards
16

qc, verifying system suitability, part of registration application, for submission to compendium

4 reasons why analytical method validation

New cards
17

identification tests, quantitative tests for impurities content, limit tests for the control of impurities, quantitative tests of active moiety in samples of drugs

4 types of analytical procedures to be validated

New cards
18

suitability of instrument, suitability of materials, suitability of analyst, suitability of documentations

4 considerations prior to method validation

New cards
19

suitability of instrument

involves status of qualification and calibration

New cards
20

suitability of materials

involves status of reference standards, reagents, etc.

New cards
21

suitability of analyst

involves status of training and qualification records

New cards
22

suitability of documentation

involves written analytical procedures and proper approved protocol with pre-established acceptance criteria

New cards
23

validation of an analytical procedure

is the process by which it is established, by laboratory studies, that the performance characteristics of the procedure meet the requirements for the intended analytical applications

New cards
24

method validation

the process for providing documented evidence that the method does what it is intended to do

New cards
25

verification

"am i building the product right?"

New cards
26

validation

"am i building the right product?"

New cards
27

validation

means confirmation by examination and provision of objective evidence that the particular requirements for specific intended use can be consistently fulfilled

New cards
28

verification

means confirmation by examination and provision of objective evidence that specified requirements have been fulfilled

New cards
29

validation

a process of seeing whether the product satisfies the customers needs or not

New cards
30

validation

it is performed to build the right product

New cards
31

validation

activities include testing of the product itself

New cards
32

verification

evaluating the process and product in development stage

New cards
33

verification

it is performed to build a product in right way

New cards
34

verification

document reviews and inspection are examples of these activities

New cards
35

validation

Characterizes performance characteristics

New cards
36

verification

Confirms that the validated methods works as intended under
Conditions of actual use.

New cards
37

a drug should be produced that is fit for its intended use

the basic principle of quality assurance

New cards
38

validation

"did we build the right model?"

New cards
39

validation

"Is the model useful?"

New cards
40

validation

"have we accurately modelled the decision problem?"

New cards
41

verification

"Did we build the model right?"

New cards
42

verification

"Is the model correctly built and functioning?"

New cards
43

verification

"Is the model free from errors?"

New cards
44

ICH Q2 R1

validation of analytical procedure

New cards
45

validation

is a process of establishing documentary evidence demonstrating that a procedure, process, or activity carried out in production or testing maintains the desired level of compliance at all stages

New cards
46

method validation

is the process used to confirm that the analytical procedure employed for a specific test is suitable for its intended use

New cards
47

international council for harmonisation of technical requirements for pharmaceuticals for human use

meaning of ICH

New cards
48

user required specification

a document stating the specified user requirement for a select piece of equipment, system, or facility

New cards
49

validation

is a process to provide assurance that instrumentations are functioning properly

New cards
50

validation master plan

a document that summarizes the firm's overall philosophy, intention, and approach to be used for establishing performance adequacy

New cards
51

Operational Qualification of HPLC (high performance liquid chromatography)

to assure that the equipment used for analysis, is operated, and qualified according to the specifications mentioned in the equipment catalog and complies with company and regulatory standards and guidance

New cards
52

UV/VIS variable wavelength detector

the objective of this test is to verify and document that the critical instruments used to monitor or control the system are operated and tested in accordance with available specification documentation

New cards
53

accuracy

an assessment of the difference between the measured value and the real value

New cards
54

precision

a measure of the agreement for multiple measurements on the same sample

New cards
55

specificity

the ability to assess the analyte when in the presence of other components

New cards
56

limits of detection and quantitation

the lowest amounts of analyte that can be detected / determined accurately, respectively

New cards
57

linearity and range

the proportionality of the measurement to the concentration of the analyte within a specified range

New cards
58

robustness

a check of the effect of deliberate small changes to the method on the results

New cards
59

trueness

unbiased results; measurement agreement with true value

New cards
60

trueness

comparison with well characterized samples and reference methods

New cards
61

precision

characterization of the agreement among test results

New cards
62

precision

involves statistical metrics

New cards
63

repeatability

precision among short term variations

New cards
64

ruggedness

precision among intermediate variations

New cards
65

reproducibility

precision among longer term variations

New cards
66

repeatability

under instrument precision

New cards
67

ruggedness

under intermediate precision

New cards
68

reproducibility

under interlaboratory precision

New cards
69

repeatability

it is the variation in measurements obtained

New cards
70

equipment, people

2 possible causes of poor repeatability

New cards
71

ruggedness

is a measure of reproducibility of test results under the variation in conditions normally expected from laboratory to laboratory and from analyst to analyst

New cards
72

specificity or selectivity

method sensitivity to potential interferences, assessments

New cards
73

method sensitivity to potential inferences

involves impurities, contaminants, degradation products; closely related compounds

New cards
74

assessment

involves chromatographic studies, peak purity tools, use of orthogonal methods, etc

New cards
75

limit of detection

lowest quantity of a substance that can be distinguished from a blank sample

New cards
76

limit of detection

point at which a measured response is larger than its uncertainty

New cards
77

limit of quantitation

meaning of LOQ

New cards
78

limit of detection

meaning of LOD

New cards
79

signal to noise ratio

meaning of SNR

New cards
80

detection limit

the lowest amount of analyte in a sample which can be detected but not necessarily quantitated as an exact value

New cards
81

quantitation limit

is the lowest amount of an analyte in a sample which can be quantitatively determined with suitable precision and accuracy

New cards
82

quantitation limit

is a parameter of quantitative assays for low levels of compounds in sample matrices, and is used particularly for the determination of impurities and/or degradation products

New cards
83

limit of detection

the smallest concentration of an analyte in a test sample that we can easily distinguish from zero

New cards
84

limit of quantitation

the smallest concentration of an analyte in a test sample that we can determine with acceptable repeatability and accuracy

New cards
85

linearity

is the ability of an analytical procedure (within a given range) to obtain test results which are directly proportional to the concentration (amount) of analyte in a sample

New cards
86

range

is the interval between the upper and lower concentration of analyte in the sample for which it has been demonstrated that the analytical procedure has a suitable level of precision, accuracy, and linearity

New cards
87

robustness

a measure of an analytical procedure's capacity to remain unaffected by small, but deliberate variations in method parameters and provides an indication of its reliability during normal usage

New cards

Explore top notes

note Note
studied byStudied by 9 people
Updated ... ago
5.0 Stars(1)
note Note
studied byStudied by 11 people
Updated ... ago
4.0 Stars(2)
note Note
studied byStudied by 5 people
Updated ... ago
5.0 Stars(1)
note Note
studied byStudied by 72 people
Updated ... ago
5.0 Stars(2)
note Note
studied byStudied by 1 person
Updated ... ago
5.0 Stars(1)
note Note
studied byStudied by 30 people
Updated ... ago
5.0 Stars(1)
note Note
studied byStudied by 28 people
Updated ... ago
5.0 Stars(1)
note Note
studied byStudied by 41 people
Updated ... ago
5.0 Stars(2)

Explore top flashcards

flashcards Flashcard27 terms
studied byStudied by 7 people
Updated ... ago
5.0 Stars(1)
flashcards Flashcard73 terms
studied byStudied by 1 person
Updated ... ago
5.0 Stars(1)
flashcards Flashcard30 terms
studied byStudied by 6 people
Updated ... ago
5.0 Stars(1)
flashcards Flashcard51 terms
studied byStudied by 12 people
Updated ... ago
5.0 Stars(1)
flashcards Flashcard92 terms
studied byStudied by 6 people
Updated ... ago
5.0 Stars(1)
flashcards Flashcard231 terms
studied byStudied by 24 people
Updated ... ago
5.0 Stars(1)
flashcards Flashcard112 terms
studied byStudied by 19 people
Updated ... ago
5.0 Stars(1)
flashcards Flashcard106 terms
studied byStudied by 3 people
Updated ... ago
5.0 Stars(1)