Brainscape's Knowledge GenomeTM

Browse over 1 million classes created by top students, professors, publishers, and experts.


See full index

Quality Control > Seminar Tanja and Lauterbach lecturs > Flashcards

Seminar Tanja and Lauterbach lecturs Flashcards

1
Q

Defination of QC

A

it is system of maintaining standards in manufactured products by testing a sample of the output against the specification

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
2
Q

What is analystical Quality Control

A

we have the QC in life science and instrumental analysis

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
3
Q

QC in life science is for

A

Screening for impurities, determining API concentration

checking of compliance against standards

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
4
Q

instrumental analysis

A

Chromatography
Spectroscopy
Crystallography

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
5
Q

on what is AAS based on?

A

it is based on the fact that atoms in the ground state can sbsorbt certain wavelengths of the elctromagentic spectrum between 190 and 850 nm

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
6
Q

What is observed in AAS and why

A

in AAS lower atomization temperatures are applied in comparison to AES
Most of the atoms are in the ground state and only transitions that emanate from the ground state , so-called resonance transition are observed

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
7
Q

Areas of application in AAS

A

enviromental monitoring, food ontrol, material sciences, clinical chemistry, QC

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
8
Q

What is validation?

A

provides a high degree of assurance that a specific process/method will consistently produce a product metting its predtermined specifications and quality attributes

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
9
Q

Types of Validation

A

Process, cleaning,computerized system validation

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
10
Q

Process Validation

A

is a data collection and assessment from production through to commerical manufacturing

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
11
Q

Cleaning validation

A

methods must verift that coontamination and cross contamination from previous productions would be prevented

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
12
Q

Computerized system validation

A

evaluation regarding their application, production and QC

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
13
Q

what’s the purpose of Computerized system validation

A

it is to verify that the computerized system specification are appropriate for the user’s needs and intended use.

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
14
Q

Method Validation

A

process of demonstrating that an analytical procedure is suitable for its intended purpose

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
15
Q

three key words in process validation

A

documented evidence of the process, perform effectively reproducibly and so meeting the predtermined specifications

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
16
Q

What is the importance of analytical procedure?

A

it is test a defined characteristic of the drug substance or DP against established acceptance criteria for that characteristic

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
17
Q

what are validation characteristics

A 
accuracy
precision
linerity
specifity
range
robustness
LOD
LOQ
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
18
Q

accuracy defination

A

closeness of agreement between the value which is accepted (concentration true value or accepted reference) and the value found

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
19
Q

Precision defination

A

closeness of agreement between a series of measurements obtained from multiple sampling of the same homogeneous sample

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
20
Q

repeatabilty

A

same operating conditions

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
21
Q

reproducibility

A

between laboratories

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
22
Q

Guidelines for Qualifications

A

EudraleX Volume 4, Annex 15, ICH, FDA, Active agent manufacturing regulation

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
23
Q

Purpose of Q and V

A

Q: documented evidents that equipment is delivering expected results
V: documented evidence that the methods or processes deliver expected results by using defined equipment and parameters

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
24
Q

Intended use of Q and V

A

Q: Facility, equipment, system
V: processes, method

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
25
Q

Responsibility for Q and V

A

Q: Head or production and head of QC
V: Head of QC (theoretical), futher department (practical)

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
26
Q

What is necessary before qualificationa and validation?

A

assessed for its risk by means of risk analysis tools, FMEA

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
27
Q

what is verification

A

Verification is when a pH.Eur. method is used

(compendium method), the applicants have to show that the method used is verify

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
28
Q

What does a qulification of an impurities mean?

A

You have to garantee that your impuries don’t excess the threshold

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
29
Q

what’s the goal of validation

A

Is not to showed that your method, rather it must work inroutine practise, change of person, sites and parameter. it is un-going process, work under route and not ideal conditions

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
30
Q

when sould methods be validated

A

Established methods, Revision of established methdos, method changes, comparison of methods, new method development
new reulatory guidelines

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
31
Q

ICH guidlines for validation means one has fulfilled everything

A

it is not a checklist, deviation from the guidline is allowed but has to be justified

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
32
Q

What is a Re-validation?

A

Applicant ahs to make sure that the actuality producer is working

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
33
Q

Who us responsible for the kind of the validation procedure used?

A

the responsibility is of the applicant

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
34
Q

Types of analytcial procedures to be validated

A

identfication of your product
qauntitative test
quantitative tests for impurities

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
35
Q

what kind of test for impurities is possible?

A

Either a quantifiction or a limit test

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
36
Q

what parameter is not part of the validation characteritics?

A

System suitability testing

37
Q

What is Specificity?

A

the method is specific if in the present of other compounds, one is able to still detect the compound to be analysed

38
Q

test for Specificity?

A

identification
purity tests (content of impurities)
Assay (content or potency)

39
Q

Determination of your assay

A

Separation factor and reolution

40
Q

Separation factor

A

ratio of the retention factors of two peaks but doesn’t consider overlapping of peaks

41
Q

Resolution

A

it is better,because it consider width of the peaks

42
Q

Determination of resolution

A

used of the width weight, the width of the maximum of the peak

43
Q

learn to caculate the separation factor and resolution

A 
SP= t(2)- t(r)/t(1)-t(r)
R = t(2)-t(1)/ 0.85 (w (1/2)2 + w (1/2)1)
44
Q

peak purity

A

designed to detect the present of an impurity

45
Q

why is specificity-peak purity the important

A

because the peak quality is not always a garantee of the purity of the peak
one has carry out Mass spectrometry

46
Q

what does the specificty assay of purity tells us?

A

impurities are available or not available

47
Q

Impurities are available

A

demonstration of the discrimination of the anlyte in the presence of imurities and or excipients by spiking pure drug substance or DP with appropraite levels of impurities

48
Q

Impurities are not available

A

comparison of the test results o samples possibly containing impurities to a second well-characterized procedure

49
Q

Recommended data to assess accuracy

A

assessment of a minimum of 9 deteminations over a minimum of 3 concentration levels
to be reported as percent recovery by the assay of knwon added amount

50
Q

Recommended data to assess precision

A

SD, RSD

51
Q

What are the three levels of precision

A

Repeatability

Intermediate precision and reproducibility

52
Q

different between Intermediate precision and reproducibility

A

laboratory and apparatus are same, while for reproducibility everything is different

53
Q

what are the critical variation for roobustness for LC

A

variation of ph in a MP, MP composition, different columns, temperature and flow rate

54
Q

what are the critical variation for roobustness for GC

A

Different columns, temperature and flow rate

55
Q

impurity quantitative and assay

A

accuarcy and precision

56
Q

Specificity is determined by?

A

identification, impurity quantitative and qualitative and assay

57
Q

LOD is used for?

A

impurity qualitative

58
Q

for what is the LOQ used for?

A

No identification, but for impurity determination and assay

59
Q

For what should the minimum specified ranges be consider

A

Assay ( DS and DP)
content uniformity

impurity quantitative: LOD and LOQ

60
Q

Definition of Specifications

A

list of test, references to analytical procedures and appropriate acceptance criteria to which a DS or DP should conform for its intended use

61
Q

proposed specifications

A

it is proposed and justified by manufacturer, to be approved by regulatory authorities

62
Q

Specification and CT

A

it does not address the clinical research stage

63
Q

Which test and acceptance criteria are appliable for new NDS and P

A

Description, identification , assay and imprities

64
Q

Which test and acceptance criteria are appliable for new chircal NDS and P

A

identity, assay and

65
Q

Legislation for specification for impurities/ degradation products

A

ICH Q6A

66
Q

ICH Q3A(R2)

A

decision tree or impurities in New drug substance

67
Q

ICH Q3B(R2)

A

Impurities in New Drug product

68
Q

What are the threshold for impurities

A

Reporting, identification and qualification threshold

69
Q

Reporting TH

A

A limit above which an impurity should be reported but not identified

70
Q

Q TH

A

TH, above which the impurity should be qualified

71
Q

What is important when using pH.Eur method?

A

thoes method are already validated, but there need to be verify

72
Q

Reference standard

A

primary (100 % purity, identity must be confirmed

secondary, working standard

73
Q

what are the three options of MAH to demonstarte the quality of their substances (Ph.Eur.)

A

Certification of suitability or CEP procedure
the active substance master file (ASMF) procedure
Compilation of the full dossierr for the chemical susbtance

74
Q

CEP procedure

A

MAH submit application to the EDQM describing the manufacturing process for the substance

75
Q

CEP and MAA

A

MAA can use the CEP as reference

76
Q

Purpose of the Cerificate of suitability

A

protection of intellectual property and know how of manufacturer

77
Q

what’s the responsibility of a CEP holder?

A

it has to prove the EDQM with a qulity dossier demonstrating the suitability

78
Q

Who has access to the CEP information

A

just the CEP holder and not the MAA and MAH

79
Q

Objective of the Active Substance Mater file (ASMF)

A

protection of intellectual property

80
Q

Restricted part of the ASMF

A

Manufacturng process, process validation

justification of specification

81
Q

QA?

A

their task is to ensure that a product under development meets specified requirements

Prevention of failure

82
Q

QC?

A

they ensure that a manufactured product adheres to a defined set of quality criteria
Detection of failure

83
Q

Focus of QA and QC?

A

QA: prevent defects
QC: identify detects

84
Q

what is the Goal of QA and QC

A

QA: to improve development and test processess
QC: identy defects after a product is developed and fore it’s released

85
Q

How does the QA, and QC works?

A

QA: establish a good management system, continuous monitoring

QC: Finding sources of quality problems

86
Q

What are the key points of QA and QC?

A

QA: prevention of quality problems

QC: maintain the product quality using analytial techniques

87
Q

responsibility QA and QC

A

QA: everyone

QC a specific team

88
Q

As a tool QA, QC

A

QA managerial rool

QC corrective tool

Quality Control (7 decks)

Brainscape helps you reach your goals faster, through stronger study habits.
© 2024 Bold Learning Solutions. Terms and Conditions