Quality Assurance EXAM PREP an der Hochschule Bonn-Rhein-Sieg | Karteikarten & Zusammenfassungen

Lernmaterialien für Quality Assurance EXAM PREP an der Hochschule Bonn-Rhein-Sieg

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TESTE DEIN WISSEN
Which law is responsible for the justification of medicinal products?
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TESTE DEIN WISSEN
Chapter 4 EU GMP-Guidelines for the Good Manufacturing of finished medicinal products
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TESTE DEIN WISSEN
What does SOP stand for?
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TESTE DEIN WISSEN
Standard Operating Procedure
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TESTE DEIN WISSEN
Name the four main steps of change of control procedure.
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TESTE DEIN WISSEN
1. Registration
2. Evaluation
3. Decision
4. Realization (of the planned changes)
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TESTE DEIN WISSEN
What is the function of the qualified person for EG guidance for GMP?
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TESTE DEIN WISSEN
Responsibilities are equal to the responsibilities of the head of quality control, but he has the overall responsibility of the finished medicinal product (including production)
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TESTE DEIN WISSEN
What is the function of the head of distribution for GMP?
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TESTE DEIN WISSEN
Responsible for the "offer for sale"
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TESTE DEIN WISSEN
During the development of finished medicinal products, three main criteria must be fulfilled before publication, which ones?
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TESTE DEIN WISSEN
Efficacy (= Wirksamkeit)
  • Safety
  • Quality
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TESTE DEIN WISSEN
What is Good Manufacturing Practice (GMP)?
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TESTE DEIN WISSEN
GMP is a quality assurance system which ensures that finished medicinal products are consistently produced and controlled according to the quality standards appropriate to their intended use, defined in the admission dosier of the responsible pharmaceutical company.
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TESTE DEIN WISSEN
The realization of the qualification of the production equipment and the validation production processes have to be carried out according to established and documented procedures, which ones?
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TESTE DEIN WISSEN
1. Planning (Masterplan, Plan, SOP)
2. Realization (with documentation)
3. Reporting (with release)
4. Revalidation in case of changes (change control)
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TESTE DEIN WISSEN
Who is responsible for the admission of finished medicinal products before publication according to the national drug law?
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TESTE DEIN WISSEN
BfArM (Federal Institute for Drugs and Medical Devices)
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TESTE DEIN WISSEN
Which three criteria are tested by the BfArM (Federal Institute for Drugs and Medical Devices) during the admission process of medicinal products?
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TESTE DEIN WISSEN
The analysis of the BfArM (Federal Institute for Drugs and Medical Devices) results in the proof of efficacy, safety and approved pharmaceutical quality.
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TESTE DEIN WISSEN
"Once a medicinal product was admitted by the BfArM (Federal Institute for Drugs and Medical Devices), the admission is valid for twenty years after a new admission is required" - Right or wrong?
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TESTE DEIN WISSEN
Wrong.

An admission is limited to five years.
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TESTE DEIN WISSEN
To which applications of the technical equipment used for the production of medicinal products do SOPs apply?
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TESTE DEIN WISSEN
- Labelling (equipment number)
- Handling of the equipment
- Performance test (qualification/calibration, specification (+/- tolerance), handling of failed tests)
- Maintainance and cleaning (log book)
- Software validation
- Backup procedure
- Change control
Lösung ausblenden
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Q:
Which law is responsible for the justification of medicinal products?
A:
Chapter 4 EU GMP-Guidelines for the Good Manufacturing of finished medicinal products
Q:
What does SOP stand for?
A:
Standard Operating Procedure
Q:
Name the four main steps of change of control procedure.
A:
1. Registration
2. Evaluation
3. Decision
4. Realization (of the planned changes)
Q:
What is the function of the qualified person for EG guidance for GMP?
A:
Responsibilities are equal to the responsibilities of the head of quality control, but he has the overall responsibility of the finished medicinal product (including production)
Q:
What is the function of the head of distribution for GMP?
A:
Responsible for the "offer for sale"
Mehr Karteikarten anzeigen
Q:
During the development of finished medicinal products, three main criteria must be fulfilled before publication, which ones?
A:
Efficacy (= Wirksamkeit)
  • Safety
  • Quality
Q:
What is Good Manufacturing Practice (GMP)?
A:
GMP is a quality assurance system which ensures that finished medicinal products are consistently produced and controlled according to the quality standards appropriate to their intended use, defined in the admission dosier of the responsible pharmaceutical company.
Q:
The realization of the qualification of the production equipment and the validation production processes have to be carried out according to established and documented procedures, which ones?
A:
1. Planning (Masterplan, Plan, SOP)
2. Realization (with documentation)
3. Reporting (with release)
4. Revalidation in case of changes (change control)
Q:
Who is responsible for the admission of finished medicinal products before publication according to the national drug law?
A:
BfArM (Federal Institute for Drugs and Medical Devices)
Q:
Which three criteria are tested by the BfArM (Federal Institute for Drugs and Medical Devices) during the admission process of medicinal products?
A:
The analysis of the BfArM (Federal Institute for Drugs and Medical Devices) results in the proof of efficacy, safety and approved pharmaceutical quality.
Q:
"Once a medicinal product was admitted by the BfArM (Federal Institute for Drugs and Medical Devices), the admission is valid for twenty years after a new admission is required" - Right or wrong?
A:
Wrong.

An admission is limited to five years.
Q:
To which applications of the technical equipment used for the production of medicinal products do SOPs apply?
A:
- Labelling (equipment number)
- Handling of the equipment
- Performance test (qualification/calibration, specification (+/- tolerance), handling of failed tests)
- Maintainance and cleaning (log book)
- Software validation
- Backup procedure
- Change control
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