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Quality Control > Seminar Tanja and Lauterbach lecturs > Flashcards

Seminar Tanja and Lauterbach lecturs Flashcards

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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

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2
Q

What is analystical Quality Control

A

we have the QC in life science and instrumental analysis

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3
Q

QC in life science is for

A

Screening for impurities, determining API concentration

checking of compliance against standards

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4
Q

instrumental analysis

A

Chromatography
Spectroscopy
Crystallography

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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

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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

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7
Q

Areas of application in AAS

A

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

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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

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9
Q

Types of Validation

A

Process, cleaning,computerized system validation

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10
Q

Process Validation

A

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

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11
Q

Cleaning validation

A

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

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12
Q

Computerized system validation

A

evaluation regarding their application, production and QC

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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.

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14
Q

Method Validation

A

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

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15
Q

three key words in process validation

A

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

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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

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17
Q

what are validation characteristics

A 
accuracy
precision
linerity
specifity
range
robustness
LOD
LOQ
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18
Q

accuracy defination

A

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

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19
Q

Precision defination

A

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

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20
Q

repeatabilty

A

same operating conditions

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21
Q

reproducibility

A

between laboratories

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22
Q

Guidelines for Qualifications

A

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

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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

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24
Q

Intended use of Q and V

A

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

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25
Responsibility for Q and V
Q: Head or production and head of QC V: Head of QC (theoretical), futher department (practical)
26
What is necessary before qualificationa and validation?
assessed for its risk by means of risk analysis tools, FMEA
27
what is verification
Verification is when a pH.Eur. method is used | (compendium method), the applicants have to show that the method used is verify
28
What does a qulification of an impurities mean?
You have to garantee that your impuries don't excess the threshold
29
what's the goal of validation
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
30
when sould methods be validated
Established methods, Revision of established methdos, method changes, comparison of methods, new method development new reulatory guidelines
31
ICH guidlines for validation means one has fulfilled everything
it is not a checklist, deviation from the guidline is allowed but has to be justified
32
What is a Re-validation?
Applicant ahs to make sure that the actuality producer is working
33
Who us responsible for the kind of the validation procedure used?
the responsibility is of the applicant
34
Types of analytcial procedures to be validated
identfication of your product qauntitative test quantitative tests for impurities
35
what kind of test for impurities is possible?
Either a quantifiction or a limit test
36
what parameter is not part of the validation characteritics?
System suitability testing
37
What is Specificity?
the method is specific if in the present of other compounds, one is able to still detect the compound to be analysed
38
test for Specificity?
identification purity tests (content of impurities) Assay (content or potency)
39
Determination of your assay
Separation factor and reolution
40
Separation factor
ratio of the retention factors of two peaks but doesn't consider overlapping of peaks
41
Resolution
it is better,because it consider width of the peaks
42
Determination of resolution
used of the width weight, the width of the maximum of the peak
43
learn to caculate the separation factor and resolution
``` 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
peak purity
designed to detect the present of an impurity
45
why is specificity-peak purity the important
because the peak quality is not always a garantee of the purity of the peak one has carry out Mass spectrometry
46
what does the specificty assay of purity tells us?
impurities are available or not available
47
Impurities are available
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
Impurities are not available
comparison of the test results o samples possibly containing impurities to a second well-characterized procedure
49
Recommended data to assess accuracy
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
Recommended data to assess precision
SD, RSD
51
What are the three levels of precision
Repeatability | Intermediate precision and reproducibility
52
different between Intermediate precision and reproducibility
laboratory and apparatus are same, while for reproducibility everything is different
53
what are the critical variation for roobustness for LC
variation of ph in a MP, MP composition, different columns, temperature and flow rate
54
what are the critical variation for roobustness for GC
Different columns, temperature and flow rate
55
impurity quantitative and assay
accuarcy and precision
56
Specificity is determined by?
identification, impurity quantitative and qualitative and assay
57
LOD is used for?
impurity qualitative
58
for what is the LOQ used for?
No identification, but for impurity determination and assay
59
For what should the minimum specified ranges be consider
Assay ( DS and DP) content uniformity impurity quantitative: LOD and LOQ
60
Definition of Specifications
list of test, references to analytical procedures and appropriate acceptance criteria to which a DS or DP should conform for its intended use
61
proposed specifications
it is proposed and justified by manufacturer, to be approved by regulatory authorities
62
Specification and CT
it does not address the clinical research stage
63
Which test and acceptance criteria are appliable for new NDS and P
Description, identification , assay and imprities
64
Which test and acceptance criteria are appliable for new chircal NDS and P
identity, assay and
65
Legislation for specification for impurities/ degradation products
ICH Q6A
66
ICH Q3A(R2)
decision tree or impurities in New drug substance
67
ICH Q3B(R2)
Impurities in New Drug product
68
What are the threshold for impurities
Reporting, identification and qualification threshold
69
Reporting TH
A limit above which an impurity should be reported but not identified
70
Q TH
TH, above which the impurity should be qualified
71
What is important when using pH.Eur method?
thoes method are already validated, but there need to be verify
72
Reference standard
primary (100 % purity, identity must be confirmed | secondary, working standard
73
what are the three options of MAH to demonstarte the quality of their substances (Ph.Eur.)
Certification of suitability or CEP procedure the active substance master file (ASMF) procedure Compilation of the full dossierr for the chemical susbtance
74
CEP procedure
MAH submit application to the EDQM describing the manufacturing process for the substance
75
CEP and MAA
MAA can use the CEP as reference
76
Purpose of the Cerificate of suitability
protection of intellectual property and know how of manufacturer
77
what's the responsibility of a CEP holder?
it has to prove the EDQM with a qulity dossier demonstrating the suitability
78
Who has access to the CEP information
just the CEP holder and not the MAA and MAH
79
Objective of the Active Substance Mater file (ASMF)
protection of intellectual property
80
Restricted part of the ASMF
Manufacturng process, process validation | justification of specification
81
QA?
their task is to ensure that a product under development meets specified requirements Prevention of failure
82
QC?
they ensure that a manufactured product adheres to a defined set of quality criteria Detection of failure
83
Focus of QA and QC?
QA: prevent defects QC: identify detects
84
what is the Goal of QA and QC
QA: to improve development and test processess QC: identy defects after a product is developed and fore it's released
85
How does the QA, and QC works?
QA: establish a good management system, continuous monitoring QC: Finding sources of quality problems
86
What are the key points of QA and QC?
QA: prevention of quality problems QC: maintain the product quality using analytial techniques
87
responsibility QA and QC
QA: everyone | QC a specific team
88
As a tool QA, QC
QA managerial rool | QC corrective tool

Quality Control (7 decks)

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