Quality accourance at Hochschule Bonn-Rhein-Sieg

Flashcards and summaries for Quality accourance at the Hochschule Bonn-Rhein-Sieg

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Exemplary flashcards for Quality accourance at the Hochschule Bonn-Rhein-Sieg on StudySmarter:

Which are the 3 main criterion that finished medicinal products which have to fulfill for the admission on the German / EU market? 

Exemplary flashcards for Quality accourance at the Hochschule Bonn-Rhein-Sieg on StudySmarter:

Testing or calibration laboratory 

Exemplary flashcards for Quality accourance at the Hochschule Bonn-Rhein-Sieg on StudySmarter:

WHAT IS GOOD MANUFACTURING Practice? 

Exemplary flashcards for Quality accourance at the Hochschule Bonn-Rhein-Sieg on StudySmarter:

•    Head of production

Exemplary flashcards for Quality accourance at the Hochschule Bonn-Rhein-Sieg on StudySmarter:

•    Head of quality control

Exemplary flashcards for Quality accourance at the Hochschule Bonn-Rhein-Sieg on StudySmarter:

Qualified person (EG guidance)

Exemplary flashcards for Quality accourance at the Hochschule Bonn-Rhein-Sieg on StudySmarter:

•    Head of distribution

Exemplary flashcards for Quality accourance at the Hochschule Bonn-Rhein-Sieg on StudySmarter:

WHAT IS THE REASON FOR THE IMPLEMENTATION OF GMP?

Exemplary flashcards for Quality accourance at the Hochschule Bonn-Rhein-Sieg on StudySmarter:

Change Control Procedure

Exemplary flashcards for Quality accourance at the Hochschule Bonn-Rhein-Sieg on StudySmarter:

ADMISSION OF FINISHED MEDICINAL PRODUCTS

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What does GMP-conform documentation mean ?

Exemplary flashcards for Quality accourance at the Hochschule Bonn-Rhein-Sieg on StudySmarter:

JUSTIFICATION BY LAW

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Exemplary flashcards for Quality accourance at the Hochschule Bonn-Rhein-Sieg on StudySmarter:

Quality accourance

Which are the 3 main criterion that finished medicinal products which have to fulfill for the admission on the German / EU market? 
Efficacy 

Quality accourance

Testing or calibration laboratory 
Accredited under DIN/ ISO/EN 17025
(not legally binding) 

Quality accourance

WHAT IS GOOD MANUFACTURING Practice? 
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 accourance

•    Head of production
Responsible for GMP-conform productionl

Quality accourance

•    Head of quality control
Responsible for the GMP-conform quality control of the finished medicinal product with reference to specification

Quality accourance

Qualified person (EG guidance)
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 accourance

•    Head of distribution
Responsible for the "offer for sale" 

Quality accourance

WHAT IS THE REASON 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
•FDA officers in corruption involved
•Consequences
Restrictions and recall from 151 of 175 products

Quality accourance

Change Control Procedure
Registration
Evaluation
Decision
Realization 

Quality accourance

ADMISSION OF FINISHED MEDICINAL PRODUCTS
•    The admission of finished medicinal products is based in the national drug law and is a main task of the BfArM (Federal institute for Drugs and Medical Devices)
•    It results in proof of
•    Efficacy
•    Safety
•    And appropriate pharmaceutical Quality
•    An admission is limited to five years


Quality accourance

What does GMP-conform documentation mean ?
•    Documents must:
•    Be created "counterfeit-proof" (forbidden: pencil!)
•    Be in 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 accourance

JUSTIFICATION BY LAW
•Chapter 4 EU GMP-Guideline for the Good Manufacturing of finished Medicinal Products 

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