quality assurance at Hochschule Bonn-Rhein-Sieg

Flashcards and summaries for quality assurance at the Hochschule Bonn-Rhein-Sieg

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Exemplary flashcards for quality assurance at the Hochschule Bonn-Rhein-Sieg on StudySmarter:

three main criterions finished medicinal products have to fulfill for the admission on the German/European market

Exemplary flashcards for quality assurance at the Hochschule Bonn-Rhein-Sieg on StudySmarter:

GMP

Exemplary flashcards for quality assurance at the Hochschule Bonn-Rhein-Sieg on StudySmarter:

head of production

Exemplary flashcards for quality assurance at the Hochschule Bonn-Rhein-Sieg on StudySmarter:

Head of quality control

Exemplary flashcards for quality assurance at the Hochschule Bonn-Rhein-Sieg on StudySmarter:

qualified person (EG guidance)

Exemplary flashcards for quality assurance at the Hochschule Bonn-Rhein-Sieg on StudySmarter:

head of distribution

Exemplary flashcards for quality assurance at the Hochschule Bonn-Rhein-Sieg on StudySmarter:

Generica scandal in the US

Exemplary flashcards for quality assurance at the Hochschule Bonn-Rhein-Sieg on StudySmarter:

reason for the implementation of GMP

Exemplary flashcards for quality assurance at the Hochschule Bonn-Rhein-Sieg on StudySmarter:

what is requested in production

Exemplary flashcards for quality assurance at the Hochschule Bonn-Rhein-Sieg on StudySmarter:

admission of finished medicinal products

Exemplary flashcards for quality assurance at the Hochschule Bonn-Rhein-Sieg on StudySmarter:

GMP conform documentation

Exemplary flashcards for quality assurance at the Hochschule Bonn-Rhein-Sieg on StudySmarter:

justification by law

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Exemplary flashcards for quality assurance at the Hochschule Bonn-Rhein-Sieg on StudySmarter:

quality assurance

three main criterions finished medicinal products have to fulfill for the admission on the German/European market
- Efficacy
- Safety
- Quality

quality assurance

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 dossier of the responsible pharmaceutical company

quality assurance

head of production
responsible for the GMP-conform production

quality assurance

Head of quality control
responsible for the GMP conform quality control of the finished medicinal product with reference to specification

quality assurance

qualified person (EG guidance)
responsibilities are equivalent to the responsibilities of the head of quality control, but he has the overall responsibility of the finished medicinal product (including the production)

quality assurance

head of distribution
responsible for the "offer for sale"

quality assurance

Generica scandal in the US
- "faked" admission dossiers
- not realized studies
- not produced batches of finished medicinal products
- not documented oos-results
- FDA officers in corruption involved

quality assurance

reason for the implementation of GMP
History: Judgement Us/Barr Laboratories inc. (1993)

generica scandal

quality assurance

what is requested in production
- qualification of equipment
- validation of processes

--> realization of the qualification of the production equipment and the validation production processes have to be carried out according to established and documented procedures
1. Planning (Master-plan, plan, SOP)
2. realization (with documentation)
3. reporting (with release)
4. Revalidation in case of changes (change control)

quality assurance

admission of finished medicinal products
- the admission of finished medicinal products is based on the national drug law and is a main task of the BfArM (federal institute for drugs and medical devices)

it results in the proof of
- Efficacy
- safety
- and appropriate pharmaceutical quality

an admission is limited to five years

quality assurance

GMP conform documentation
documents must...
- be created "counterfeit-proof" (forbidden: Pencil!)
- be readable typeface and clearly arranged
- be faultless and understandable
- be checkable easily
- be approved, dated and signed several times (by different responsible persons)
- be checked and updated regularly
- be created "just in time"

quality assurance

justification by law
chapter 4 EU GMP guideline for the good manufacturing of finished medicinal products

4.1 description of procedures
description of procedures include regulations for the enforcement of certain tasks just as
- cleaning
- changing of clothes
- supervision of the environment
- sampling
- sample work up
- the usage of technical equipment

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