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Quality Managment > Process Validation > Flashcards

Process Validation Flashcards

1
Q

What are arease of the validation master plan?

A

Media systems, production plants, Hygiene Master plan, process validation and computerized system validation

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2
Q

What the traditional process validation way?

A

the process was carried out and the quality of the final product was tested with 3 commercial batches. if the validation was sucessful, no further validation was needed

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3
Q

How was the process define in the traditional process validation?

A

the process was define by the quality of the product

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4
Q

What is the different to today’s process validation in comparision to the TPV?

A

we have the specify proces controls by assessing the process capability

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5
Q

why the TRV not optimal?

A

because there is not enough interactions between process parameters and quality attributes of products

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6
Q

What is used to address the process validation?

A

the life cycle approach

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7
Q

in which guidelines is the LCA meantioned?

A

FDA and EMA: process validation

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8
Q

What are the three phases of the PV

A
  1. Process Design
  2. Process validation
  3. Continued Process verification
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9
Q

How can you summarized the LCA?

A

Validation is a three phase continous process with ongion effort for the entire life cycle of the product

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10
Q

What happend in phase 1

A

Process Design: the research and development phase, which involves defining a process for manufacturing of a product

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11
Q

what are the process that are define?

A

QTPP, CQAs, CPPs, Conducting risk assessments and control strategy id defined

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12
Q

Was has to be consider in the regulatory point of view?

A

an essential component of this stage is meticulous and comprehensive record keeping

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13
Q

What is a QTPP and where is it define?

A

it is a prospective summary of the quality characteristics of a drug product. it is carry out to ensure the quality of the product and so taking into account safety and efficacy. is the defin in ICH Q8 (R2) guidline

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14
Q

What is the CQA?

A

a physical, chemicl or biological or microbiological property or characteristic that should b within an appropriate limit range, or distribution to ensure the desired product quality

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15
Q

which steps has to be establish to understand a process?

A 
identify of CMQ and CPP
Use of risk assesssment 
levels or range of these risk attributes
Design and conduct experiments (DoE)
Analyze the experimental data (CMA and CPP)
Develop a control strategy
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16
Q

why do we perform a RA?

A

to identify the high risk steps that may affect the CQA of the final drug product

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17
Q

which steps are part of the control strategy?

A

Raw material,
quality attributes (in-line, on-line or at-line)
Process parameters
intermediates
enviromental factors
Alorithms to adapt procesess based on applied PAT
CAPA

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18
Q

Summary of phase 1: process design

A
  • Manufacturing process is defined
  • CQA’s are identified
  • Process knowledge is estabilshed
  • Control strategies are specified
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19
Q

Phase 2: porcess validation includes?

A

building and facilities
transportation of raw materials
knowledge, traning

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20
Q

What does the validation strategies prove?

A

that a porcess is robust, resulting in consistent product quality

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21
Q

What are the steps in the EMA guideline on process, regarding the traditional process?

A

Traditional developmenzt
Traditional validation
Validation batches

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22
Q

What are the steps in the EMA guideline on process, regarding the today’s approache?

A

Quality by design development
continous process verification
verfied control strategy

23
Q

what is the QbD?

A

process comprehesion, obtaining knowledge such as
the sequenceof the production steps during manufacturing
most important and critical process parameters(CPPs)
interrelation betweent theCPPs and their impact

24
Q

what happend after creating the DS?

A

different CPPs and other infuencing factors are combine

product quality is still verified

25
Q

what happend after defining and approval of your DS?

A

changes within the DS are not desined as changes of the production process and no frther authorisation is required

26
Q

What do you used to do create the DS?

A

DoE

27
Q

what’s the advantage of the DoE?

A

one gain great possible knowledge about the interraltion between infuencing variables and outcomes
to differentiate between significant and insignificant factors

28
Q

Summary of the Phase 2 is?

A

-continous verification or traditional approcach
qualification of premises
implementation of the control strategie

29
Q

what are the main step in the CPV?

A

it involves ongoing validation during production and to obatined consistent quality

30
Q

what is the aim of CPV?

A

detect and resolve process drift

31
Q

what does the CPV involves?

A

product sampling, analysis and verification

32
Q

what is required at the CPV?

A

an comprehensive record-keeping

33
Q

What are the elemnts of CPV

A

ongoing comparsion of CQA and CPP
quality control charts
evaluation of process capability and analysis of trends

34
Q

ongoing comparsion of CQA and CPP means?

A

in-line/on-line monitoring of the process

carefully designed smapling procedure (off-line/at-line)

35
Q

evaluation of process capability and analysis of trends

A

Data distribution based on random errors or systematic errors
stable and controlled procesess?

36
Q

Why do we used quality control charts?

A

it helps to visaulize the behaviour of processess

37
Q

which variation can occured and which is okay in a process?

A

Random and specific variation, where the random variation is okay

38
Q

1 point more than 3s from the centerline indicates?

A

indication of a displacement of the mean, standard devaition or single outlier in measurement

39
Q

9 suceesive points on one side of the centerline indicates?

A

sfift of the mean value

40
Q

6 consecutive points all increasing or decreasing siginfy?

A

a trend

41
Q

14 consecutive points, alternating up and down signs?

A

that the date comes from two different sources

42
Q

the QCC is devided into?

A

shewhart/ process behaviou-QCC and Acceptance CC

43
Q

shewhart/ process behaviou-QCC is devided into?

A

Qualitative and quantitative attribues

44
Q

Acceptance CC is an

A

Quantitative attribues CC

45
Q

example of a Qualitative attributes chart

A

x-QCC, p-chart, c-chart

46
Q

Quantitative attributes chart is devied into?

A

Simple, Double and QCC with memory

47
Q

Simple QCC example

A

x, x-bar, s and R chart

48
Q

Double QCC example

A

x-bar and s-chart

x-bar and R-QCC

49
Q

QCC with memory

A

Cusum, EWMA and Mosum

50
Q

What are process capability

A

have to still write

51
Q

summayr of phase 3

A
  • assessment of process-related information
  • statistical trend-and failure analysis
  • change control
  • re-validation after critical changes
52
Q

what are the changes made during the PV?

A

frim a selective, temporarliy limited project towards a central tool for qA, continuously supporting a process or product during its lifetime

53
Q

other changes are?

A

Life-cycle approach instead of isolated actions
continuous evaluation of data instead of collecting evidence
Risk-based actions instead of maximal completion

Quality Managment (8 decks)

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