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Lernmaterialien für quality assurance an der Hochschule Bonn-Rhein-Sieg

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

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- Efficacy
- Safety
- Quality

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GMP

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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

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CRO (contract research organization)

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outsourcing partner for the production and the quality control of finished medicinal products

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qualification (equipment)

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

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in process controls

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Controls, which take place immediately before finishing a manufacturing step

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Generica scandal in the US

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

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SOP (standard operating procedure)

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written test procedures with documented instructions about the enforcement of repeated actions (e.g. methods, testing instruments), laboratory low!!

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what is requested in production

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- 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)

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admission of finished medicinal products

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- 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

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qualified person (EG guidance)

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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)

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justification by law

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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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head of distribution

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responsible for the "offer for sale"

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  • 77728 Karteikarten
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  • 96 Lernmaterialien

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Q:

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

A:

- Efficacy
- Safety
- Quality

Q:

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 dossier of the responsible pharmaceutical company

Q:

CRO (contract research organization)

A:

outsourcing partner for the production and the quality control of finished medicinal products

Q:

qualification (equipment)

A:

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

Q:

in process controls

A:

Controls, which take place immediately before finishing a manufacturing step

Mehr Karteikarten anzeigen
Q:

Generica scandal in the US

A:

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

Q:

SOP (standard operating procedure)

A:

written test procedures with documented instructions about the enforcement of repeated actions (e.g. methods, testing instruments), laboratory low!!

Q:

what is requested in production

A:

- 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)

Q:

admission of finished medicinal products

A:

- 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

Q:

qualified person (EG guidance)

A:

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)

Q:

justification by law

A:

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

Q:

head of distribution

A:

responsible for the "offer for sale"

quality assurance

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