quality assurance at Hochschule Bonn-Rhein-Sieg

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

CRO (contract research organization)

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:

qualified person (EG guidance)
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Exemplary flashcards for quality assurance at the Hochschule Bonn-Rhein-Sieg on StudySmarter:

qualification (equipment)

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:

head of production

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

admission of finished medicinal products
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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:

reason for the implementation of GMP

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:

Head of quality control

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

quality assurance

CRO (contract research organization)
outsourcing partner for the production and the quality control of finished medicinal products

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

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

qualification (equipment)
qualification is the documented proof, that provides a high degree of safety, so that a equipment is in accordance with his specification

quality assurance

head of distribution
responsible for the "offer for sale"

quality assurance

head of production
responsible for the GMP-conform production

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

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

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

generica scandal

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

quality assurance

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

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