SubjectsSubjects(version: 996)
Course, academic year 2026/2027
   
Industrial Production of Pharmaceutical Preparations - GAF378
Title: Industrial Production of Pharmaceutical Preparations
Form of teaching: lecture+seminar+practical classes
Guaranteed by: Department of Pharmaceutical Technology (16-16210)
Faculty: Faculty of Pharmacy in Hradec Králové
Actual: from 2026
Duration in semesters: 1
Semester: summer
Points: 0
E-Credits: 4
Examination process: summer s.:written
Hours per week, examination: summer s.:10/50, C+Ex [HS]
Capacity: unknown / unknown (6)
Maximum number of enrolled students: 6
Min. number of students: unlimited
4EU+: no
Virtual mobility / capacity: no
Key competences:  
State of the course: taught
Language: English
Teaching methods: full-time
Level:  
Repeated enrollment: 1 / 1 / - / 1
Note: course can be enrolled in outside the study plan
enabled for web enrollment
Guarantor: Mgr. Monika Smékalová, Ph.D.
Co-requisite : GAF346
Is interchangeable with: GAF319, GAF318
Annotation -
Elective course, summer semester. The course is related to Pharmaceutical Technology 1 and 2 and Development of Pharmaceutical Products. It is intended for students who wish to expand their knowledge of pharmaceutical technology, particularly manufacturing technologies used in large-scale production. Lectures and seminars are followed by four days of practical training at Teva in Opava-Komárov, where oral tablets, hard and soft gelatin capsules, syrups, oral drops, nasal sprays, and skin sprays are produced. The lectures start in late April or early May, and the internship takes place in MAY. Teva provides a fixed contribution towards accommodation and covers the cost of lunches at the company. STUDENTS ARE RESPONSIBLE FOR ARRANGING THEIR OWN ACCOMMODATION. Teaching is provided by Teva’s professional staff. The course is part of the Pharmaceutical Technology specialization. The capacity is limited to 5 students. In case the capacity is exceeded, preference is given to students enrolled in the Pharmaceutical Technology specialization.
Last update: Smékalová Monika, Mgr., Ph.D. (24.09.2026)
Course completion requirements -
Full attendance is required for all theoretical lectures and seminars, as well as for the practical training at Teva.
Last update: Smékalová Monika, Mgr., Ph.D. (17.09.2026)
Literature -

Recommended:

  • . . 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..

Last update: Smékalová Monika, Mgr., Ph.D. (01.12.2025)
Teaching methods -

  • lectures
  • seminars
  • internship

The teaching includes theoretical blocks (late April/May) and an internship (a combination of the theoretical and practical teaching, May).

Teaching is provided by specialists from Teva.

Last update: Smékalová Monika, Mgr., Ph.D. (17.09.2026)
Course assessment methods and requirements for successful completion, grading scheme -
The course is completed by passing a written examination. A minimum score of 60% is required to pass.
Last update: Smékalová Monika, Mgr., Ph.D. (29.09.2026)
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)

·         Internship in TEVA Czech Industries s.r.o.

Last update: Smékalová Monika, Mgr., Ph.D. (01.12.2025)
Learning resources -
Information regarding the financial contribution towards accommodation, the internship, and study materials will be available on the Faculty of Pharmacy website. https://intranet.faf.cuni.cz/Study-materials/KFT
Last update: Smékalová Monika, Mgr., Ph.D. (24.09.2026)
Learning outcomes

   

The course Industrial Production of Pharmaceutical Preparations builds on the knowledge and skills acquired in the courses Pharmaceutical Technology 1 and 2 and Development of Pharmaceutical Products.

After completing the course, the students will be able to use the following terms (including their commonly used abbreviations) in the correct context towards the industrial production of pharmaceutical products: VYR-32, VYR-36, Good Manufacturing Practice (GMP), Quality Control (QC), Quality Assurance (QA), GLP, generic, active ingredient, excipient, cleanroom, HVAC, purity class, microbial contamination level, sanitation, disinfection, HEPA filter, standard operating procedures (SOPs), biopharmaceutical classification system (BCS), validation, tamper evident technology, serialisation, ICH platform, summary of product characteristics (SmPC), common technical document (CTD), bioequivalence studies.

Learning outcomes:

Based on the knowledge and skills acquired, students will be able to:

Ø  describe quality systems and GMP requirements

Ø  explain requirements for staff, facilities, documentation, materials, stability studies and GMP processes

Ø  discuss generics research and development, preformulation development tasks and clinical trials

Ø  describe the requirements and processes associated with registration

Ø  describe the requirements for manufacturing facilities and production equipment

Ø  describe anti-counterfeiting options

Ø  describe the classification of liquid dosage forms, their properties, evaluation and quality assurance

Ø  describe technological procedures of production of liquid dosage forms

Ø  describe the specifications of water for pharmaceutical purposes

Ø  describe the types of GMP-compliant documentation

Ø  describe and discuss the process of manufacturing solid dosage forms

Students will gain experience with manufacturing processes and facilities during the internship.

Last update: Smékalová Monika, Mgr., Ph.D. (01.12.2025)
 
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