Subjects

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Pharmaceutical Engineering - D111018

Title:	Farmaceutické inženýrství
Guaranteed by:	Department of Organic Technology (111)
Faculty:	Faculty of Chemical Technology
Actual:	from 2013 to 2019
Semester:	winter
Points:	winter s.:0
E-Credits:	winter s.:0
Examination process:	winter s.:
Hours per week, examination:	winter s.:0/0, other [HT]
Capacity:	unknown / unknown (unknown)
Min. number of students:	unlimited
State of the course:	taught
Language:	Czech
Teaching methods:	full-time
Level:
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.

Examination dates Schedule

Annotation -

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.

Last update: TAJ111 (08.04.2014)

Course completion requirements -

Final verbal exam

Last update: TAJ111 (08.04.2014)

Literature -

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

Last update: TAJ111 (17.04.2014)

Syllabus -

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

Last update: TAJ111 (08.04.2014)

Learning resources -

Teacher provides PDF copies of lectures.

Last update: TAJ111 (08.04.2014)

Learning outcomes -

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

Last update: TAJ111 (17.04.2014)

Entry requirements -

Chemical Engineering

Last update: TAJ111 (08.04.2014)

Coursework assessment
Form	Significance
Oral examination	100