ICH Q9 /10 Flashcards
What is the main priciples of the QRM?
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
What is a risk?
Defined as the combination of the probability of occurrence of a harm and the severity of that harm
Risk identification?
they systematic use of information to identify potential sources of harm /hazrds referring to the risk
Risk anylsis?
the estimation of the risk associated with the identifed hazards
Risk Evaluation?
the comparison of the estimated risk to gven risk criteria using a quantitative or qualitative scale to determine the siginificance of the risk
Risk Reduction?
Actions taken to lessen the probability of occurrence of harm and the sverity of that harm
risk acceptance?
the decision to accpet risk
risk review?
Review or monitoring of output7results of the RMP
Risk communication?
information about risk and risk management between the decision maker and other stakeholders
Risk management tools?
FMEA
FTA
HAZOP (Hazard Operability anaylsis)
Failure Mode and Effect Analysis? (know how to draw it)
Error avoidance principle/preventive principle –> Bottom-up-anylsis
Fault Tree Analysis?
Errors and their consequences are depicted in a pictogram–> Top-Down anlysis
(Relies on th expert process understanding)
What is Quality?
the degree of agreement between expectations and properties of a product
ICH Q10 is?
Pharmaceutical quality system
ICH Q10 is based on?
Elements of the ISO 9000 series and the GMP Guidelines
3 main objectives of the Guideline?
Achieve product Realisation
Establish and Maintain a state of control
Facilitae continual provement
Lifecycle stage Goals? pharmacutical development?
design a product and process
that consistently delivers the intended
quality and performance and meets the
needs of customers
What is the Pharmaceutical Quality system elements?
Process Performance and product quality
CAPA (Corrective and precventive action)
Change Management System (Chnage control)
Management review
Process Performance and product quality includes?
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Risk Management (In Process Control, Specifications)
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Data Management
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Feedback Management ( complaints, product rejection)
Immediate action is?
Deviation is corrected immediately and the system is set to initial state.
Corrective actions
The recurrence of the deviation is to be prevented.
Preventive measures?
Preventive measures: Findings from the deviation should also be applied to other
products/processes.
Change control?
Managemnet of changes affecting the product properties, the manufacturing process, but also tests methods and raw materials
CC is a process to?
Control planned changes
evalute their impact on product quality
determine the resulting consequences for approvaö
define actions that enable the chnage to be implemented
Quality Manual content
the quality policy
the scope of the QMS
identification of sequences, linkages and interdependencies
Management responsibilities within the QMS
