SubjectsSubjects(version: 855)
Course, academic year 2019/2020
  
Pharmaceutical Engineering - D111018
Title: Farmaceutické inženýrství
Guaranteed by: Department of Organic Technology (111)
Actual: from 2013
Semester: winter
Points: winter s.:0
E-Credits: winter s.:0
Examination process: winter s.:
Hours per week, examination: winter s.:0/0 other [hours/week]
Capacity: unknown / unknown (unknown)
Min. number of students: unlimited
Language: Czech
Teaching methods: full-time
Level:  
For type:  
Additional information: http://Termín konání přednášek je třeba domluvit s vyučujícím (Zdenka.Mrvova@zentiva.cz)
Note: course is intended for doctoral students only
can be fulfilled in the future
Guarantor: Mrvová Zdenka Ing.
Annotation -
Last update: TAJ111 (08.04.2014)
The branch deals with basic principles of pharmaceutical engineering and characteristic of dosage forms. The process of development pharmaceutical forms is mentioned, as well as manufacturing methods, processes and manufacturing facilities in pharmaceutical industry; principles of validation processes and products and the related risk analysis and technology transfer. Mentioned are also principles GMP, quality assurance and quality control, and drug regulation.
Aim of the course -
Last update: TAJ111 (17.04.2014)

The students will be able to:

1. Basic principles for the development and manufacture of dosage forms

2. Processes and equipment for manufacture of dosage forms

3. Principles of validation, risk analysis, technology transfer

Literature -
Last update: TAJ111 (17.04.2014)

R: Pavel Komárek,Miroslava Rabišková : Technologie léků

Český lékopis

A:SUKL -Pokyny VYR -32 verze 3 Úvod k pokynům pro správnou výrobní praxi:SUKL -Pokyny VYR -32 kapitola 1 Řízení jakosti

A:SUKL- Pokyny VYR -32 kapiltola 3 Prostory a zařízení

A:SUKL -Pokyny VYR -32 kapitola 5 Výroba

A:SUKL -Pokyny VYR -32 kapitola 6 Kontrola jakosti

A:SUKL -Pokyny VYR -32 Doplněk 1 verze 1 Výroba sterilních léčivých přípravků

A:SUKL -Pokyny VYR -32 Doplněk 9 Výroba tekutých lékových forem,krémů a mastí

A:SUKL -Pokyny VYR -32 Doplněk 15 Kvalifikace a validace

A:SUKL -Pokyny VYR -32 Doplněk 20 Řízení rizik pro jakost

Learning resources -
Last update: TAJ111 (08.04.2014)

Teacher provides PDF copies of lectures.

Syllabus -
Last update: TAJ111 (08.04.2014)

1. Principles of pharmaceutical enginnering

2. Dosage forms

3. Development proces of dosage forms

4. Manufacturing procedures and processes in pharmaceutical manufacturing

5. Manufacturing equipment in pharmaceutical manufacturing

6. Validation of processes

7. Product validation

8. Principles of GMP

9. Risk analysis

10. Scale-up a technology transfer

11. Quality Assurance and Quality Control

12. Regulation

Entry requirements -
Last update: TAJ111 (08.04.2014)

Chemical Engineering

Course completion requirements -
Last update: TAJ111 (08.04.2014)

Final verbal exam

Coursework assessment
Form Significance
Oral examination 100

 
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