Subjects

Your browser does not support JavaScript, or its support is disabled. Some features may not be available.

Industrial Production of Pharmaceutical Preparations - GAF378

Title:	Industrial Production of Pharmaceutical Preparations
Guaranteed by:	Department of Pharmaceutical Technology (16-16210)
Faculty:	Faculty of Pharmacy in Hradec Králové
Actual:	from 2021
Semester:	summer
Points:	0
E-Credits:	4
Examination process:	summer s.:written
Hours per week, examination:	summer s.:10/50, C+Ex [HS]
Capacity:	unlimited / unlimited (5)
Min. number of students:	unlimited
4EU+:	no
Virtual mobility / capacity:	no
Key competences:
State of the course:	taught
Language:	English
Teaching methods:	full-time
Teaching methods:	full-time
Level:
Note:	course can be enrolled in outside the study plan enabled for web enrollment

Guarantor:	doc. PharmDr. Zdeňka Šklubalová, Ph.D.
Co-requisite :	GAF346
Interchangeability :	GAF271, GAF318, GAF319

Examination dates SS schedule

Annotation -

Last update: doc. PharmDr. Zdeňka Šklubalová, Ph.D. (01.10.2021)

Industrial Production of Pharmaceutical Preparations (4th section) The subject is related to the subject Pharmaceutical Technology 1 and 2 and deals to the students who would like to enlarge their knowledge in Pharmaceutical Technology, particularly in manufacturing technologies used in the large-scale production . The subject belongs to Area of Specialization in Pharmaceutical Technology The capacity limit: 5 Lectures/seminars take place in the 12th week of semester. The five-days training takes place in Teva, Opava-Komárov in the 13th week of semester (May). Topics: Research, development & registration of pharmaceutical products, Liquid & solid dosage forms, production, packaging, Soft gelatine capsules, Quality management (QC, QA) An accomodation in Opava (5 nights – bed & breakfast), transfer to Opava-Komarov (the location of company) and the meal in company (a lunch) is paid by Teva company. Further costs (train to Opava, etc.) is paid by students.

Course completion requirements -

Last update: doc. PharmDr. Zdeňka Šklubalová, Ph.D. (04.12.2021)

The subject is concluded by passing the written exam.

100% presence is required in teoretical and practical training (in Teva).

Literature -

Last update: doc. PharmDr. Zdeňka Šklubalová, Ph.D. (04.12.2021)

Obligatory:

. . In Allen, Loyd V.. Pharmaceutical dosage forms and drug delivery systems . Philadelphia: Wolters Kluwer, 2018, s. -. ISBN 978-1-4963-7291-8..

. . In Allen, Loyd V. (ed.). Remington : an introduction to pharmacy . London: Pharmaceutical Press, 2013, s. -. ISBN 978-0-85711-104-3..

. . In Allen, Loyd V.. The art, science, and technology of pharmaceutical compounding . Washington, D.C.: American Pharmacists Association, 2012, s. -. ISBN 978-1-58212-164-2..

Syllabus -

Last update: doc. PharmDr. Zdeňka Šklubalová, Ph.D. (01.10.2021)

Syllabus

• Development and registration of pharmaceutical products

• Technical aspects of pharmaceutical manufacturing (store and waste management)

• Manufacturing of liquid dosage forms

• Manufacturing of solid dosage forms

• Quality control (QC) and quality analysis (QA)

• TAPI and manufacturing of cytostatics

Learning resources -

Last update: doc. PharmDr. Zdeňka Šklubalová, Ph.D. (04.12.2021)

Study materials available at department web site https://intranet.faf.cuni.cz/Study-materials/KFT

Teaching methods -

Last update: doc. PharmDr. Zdeňka Šklubalová, Ph.D. (01.10.2021)

Lectures/seminars take place in the 12th week of semester.

The five-days training takes place in Teva, Opava-Komárov in the 13th week of semester (May).

Topics: Research, development & registration of pharmaceutical products, Liquid & solid dosage forms, production, packaging, Soft gelatine capsules, Quality management (QC, QA)

An accomodation in Opava (5 nights – bed & breakfast), transfer to Opava-Komarov (the location of company) and the meal in company (a lunch) is paid by Teva company. Further costs (train to Opava, etc.) is paid by students

Requirements to the exam -

Last update: doc. PharmDr. Zdeňka Šklubalová, Ph.D. (04.12.2021)

100% presence at teaching (theoretical, practical in Teva )

Written test, minimum 75 % of correct answers