ICH Q9 /10

Question 1

What is the main priciples of the QRM?

Answer 1

the evaluation of risks should be based on scientifc knowledge and should ultimately link to the protection of patients

the level of effort should be commensurate with the level of risk

Question 2

What is a risk?

Answer 2

Defined as the combination of the probability of occurrence of a harm and the severity of that harm

Question 3

Risk identification?

Answer 3

they systematic use of information to identify potential sources of harm /hazrds referring to the risk

Question 4

Risk anylsis?

Answer 4

the estimation of the risk associated with the identifed hazards

Question 5

Risk Evaluation?

Answer 5

the comparison of the estimated risk to gven risk criteria using a quantitative or qualitative scale to determine the siginificance of the risk

Question 6

Risk Reduction?

Answer 6

Actions taken to lessen the probability of occurrence of harm and the sverity of that harm

Question 7

risk acceptance?

Answer 7

the decision to accpet risk

Question 8

risk review?

Answer 8

Review or monitoring of output7results of the RMP

Question 9

Risk communication?

Answer 9

information about risk and risk management between the decision maker and other stakeholders

Question 10

Risk management tools?

Answer 10

FMEA
FTA
HAZOP (Hazard Operability anaylsis)

Question 11

Failure Mode and Effect Analysis? (know how to draw it)

Answer 11

Error avoidance principle/preventive principle –> Bottom-up-anylsis

Question 12

Fault Tree Analysis?

Answer 12

Errors and their consequences are depicted in a pictogram–> Top-Down anlysis
(Relies on th expert process understanding)

Question 13

What is Quality?

Answer 13

the degree of agreement between expectations and properties of a product

Question 14

ICH Q10 is?

Answer 14

Pharmaceutical quality system

Question 15

ICH Q10 is based on?

Answer 15

Elements of the ISO 9000 series and the GMP Guidelines

Question 16

3 main objectives of the Guideline?

Answer 16

Achieve product Realisation
Establish and Maintain a state of control
Facilitae continual provement

Question 17

Lifecycle stage Goals? pharmacutical development?

Answer 17

design a product and process
that consistently delivers the intended
quality and performance and meets the
needs of customers

Question 18

What is the Pharmaceutical Quality system elements?

Answer 18

Process Performance and product quality
CAPA (Corrective and precventive action)
Change Management System (Chnage control)
Management review

Question 19

Process Performance and product quality includes?

Answer 19

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Risk Management (In Process Control, Specifications)
-
Data Management
-
Feedback Management ( complaints, product rejection)

Question 20

Immediate action is?

Answer 20

Deviation is corrected immediately and the system is set to initial state.

Question 21

Corrective actions

Answer 21

The recurrence of the deviation is to be prevented.

Question 22

Preventive measures?

Answer 22

Preventive measures: Findings from the deviation should also be applied to other
products/processes.

Question 23

Change control?

Answer 23

Managemnet of changes affecting the product properties, the manufacturing process, but also tests methods and raw materials

Question 24

CC is a process to?

Answer 24

Control planned changes
evalute their impact on product quality
determine the resulting consequences for approvaö
define actions that enable the chnage to be implemented

Question 25

Quality Manual content

Answer 25

the quality policy
the scope of the QMS
identification of sequences, linkages and interdependencies
Management responsibilities within the QMS