Quality Assurance EXAM PREP at Hochschule Bonn-Rhein-Sieg

Flashcards and summaries for Quality Assurance EXAM PREP at the Hochschule Bonn-Rhein-Sieg

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Study with flashcards and summaries for the course Quality Assurance EXAM PREP at the Hochschule Bonn-Rhein-Sieg

Exemplary flashcards for Quality Assurance EXAM PREP at the Hochschule Bonn-Rhein-Sieg on StudySmarter:

During the development of finished medicinal products, three main criteria must be fulfilled before publication, which ones?

Exemplary flashcards for Quality Assurance EXAM PREP at the Hochschule Bonn-Rhein-Sieg on StudySmarter:

What is Good Manufacturing Practice (GMP)?

Exemplary flashcards for Quality Assurance EXAM PREP at the Hochschule Bonn-Rhein-Sieg on StudySmarter:

What is the function of the head of production for GMP?

Exemplary flashcards for Quality Assurance EXAM PREP at the Hochschule Bonn-Rhein-Sieg on StudySmarter:

What is the function of the head of quality control for GMP?

Exemplary flashcards for Quality Assurance EXAM PREP at the Hochschule Bonn-Rhein-Sieg on StudySmarter:

What is the function of the qualified person for EG guidance for GMP?

Exemplary flashcards for Quality Assurance EXAM PREP at the Hochschule Bonn-Rhein-Sieg on StudySmarter:

What is the function of the head of distribution for GMP?

Exemplary flashcards for Quality Assurance EXAM PREP at the Hochschule Bonn-Rhein-Sieg on StudySmarter:

Name the reason ("historically") for the implementation of GMP.

Exemplary flashcards for Quality Assurance EXAM PREP at the Hochschule Bonn-Rhein-Sieg on StudySmarter:

Which three general validations/qualifications are requested in the production of a medicinal product?

Exemplary flashcards for Quality Assurance EXAM PREP at the Hochschule Bonn-Rhein-Sieg on StudySmarter:

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?

Exemplary flashcards for Quality Assurance EXAM PREP at the Hochschule Bonn-Rhein-Sieg on StudySmarter:

Who is responsible for the admission of finished medicinal products before publication according to the national drug law?

Exemplary flashcards for Quality Assurance EXAM PREP at the Hochschule Bonn-Rhein-Sieg on StudySmarter:

Which three criteria are tested by the BfArM (Federal Institute for Drugs and Medical Devices) during the admission process of medicinal products?

Exemplary flashcards for Quality Assurance EXAM PREP at the Hochschule Bonn-Rhein-Sieg on StudySmarter:

"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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Exemplary flashcards for Quality Assurance EXAM PREP at the Hochschule Bonn-Rhein-Sieg on StudySmarter:

Quality Assurance EXAM PREP

During the development of finished medicinal products, three main criteria must be fulfilled before publication, which ones?
Efficacy (= Wirksamkeit)
  • Safety
  • Quality

Quality Assurance EXAM PREP

What is Good Manufacturing Practice (GMP)?
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.

Quality Assurance EXAM PREP

What is the function of the head of production for GMP?
Responsible for GMP-conform production

Quality Assurance EXAM PREP

What is the function of the head of quality control for GMP?
Responsible for the GMP-conform quality control of the finished medicinal product with reference to specification

Quality Assurance EXAM PREP

What is the function of the qualified person for EG guidance for GMP?
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)

Quality Assurance EXAM PREP

What is the function of the head of distribution for GMP?
Responsible for the "offer for sale"

Quality Assurance EXAM PREP

Name the reason ("historically") for the implementation of GMP.
  • History: Judgement US/Barr Laboratories Inc. (1993)

  • The "Generica-scandal" in the US 
- Faked admission dosiers
- Not realized studies
- Not produced batches of finished medicinal products
- Not documented oos-results (Out Of Specification)
- FDA officers in corruption involved

Consequences (e.g. Restrictions and recall from 151 of 175 products)

Quality Assurance EXAM PREP

Which three general validations/qualifications are requested in the production of a medicinal product?
Qualification of equipment
Validation of processes
Validation of production

Quality Assurance EXAM PREP

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?
1. Planning (Masterplan, Plan, SOP)
2. Realization (with documentation)
3. Reporting (with release)
4. Revalidation in case of changes (change control)

Quality Assurance EXAM PREP

Who is responsible for the admission of finished medicinal products before publication according to the national drug law?
BfArM (Federal Institute for Drugs and Medical Devices)

Quality Assurance EXAM PREP

Which three criteria are tested by the BfArM (Federal Institute for Drugs and Medical Devices) during the admission process of medicinal products?
The analysis of the BfArM (Federal Institute for Drugs and Medical Devices) results in the proof of efficacy, safety and approved pharmaceutical quality.

Quality Assurance EXAM PREP

"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?
Wrong.

An admission is limited to five years.

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