Veidlapa Nr. M-3 (8)
Study Course Description
Good Manufacturing Practice
Course Code
LFK_043
Branch of Science
Basic medicine; Technology of Drug Forms
ECTS
3.00
Target Audience
Pharmacy
LQF
Level 7
Study Type And Form
Full-Time
Study Course Implementer
Course Supervisor
Marina Timošenko
Structure Unit Manager
Baiba Mauriņa
Structural Unit
Department of Applied Pharmacy
Contacts
Riga, Dzirciema street 16, zftk@rsu.lv, +371 67061547
About Study Course
Objective
1. To promote the acquisition of knowledge and forming of understanding of the nature of good manufacturing practice and the importance of requirements in the manufacture of high-quality medicinal products.
2. To promote the acquisition of practical skills for the preparation of information materials for introductory instruction and training on good manufacturing practice.
Preliminary Knowledge
In inorganic and organic chemistry, quantitative analysis, plant and animal biology, mathematics and computer science, physics, medical biochemistry, environmental health, microbiology, medicinal chemistry, pharmaceutical chemistry, pharmacognosy with phytopharmacy course, English.
Learning Outcomes
Knowledge
1.The student gains knowledge that will enable them to understand: GMP guidelines for medicinal products; quality systems applied in the pharmaceutical industry; quality requirements for manufacturing processes in both small-scale and industrial-scale production of pharmaceutical products, including standard operating procedures (SOPs) and monitoring standards required to achieve appropriate quality levels; the relative importance of quality control testing and manufacturing monitoring in ensuring product quality; manufacturing process validation, the role and responsibilities of the qualified person.
Skills
1.As a result of completing the study course, students will be able to assess the influence of manufacturing and storage conditions on the quality of medicinal products, to develop and validate analytical methods for assessing the quality of active substances, excipients, materials, intermediates and final products (finished dosage forms) in accordance with the European Pharmacopoeia, to standardise finished dosage forms, prepare documentation in accordance with GMP and EU guidelines for medicinal products, depending on market requirements, ensure the establishment of a quality control system in a pharmaceutical company, manage the quality control system in a pharmaceutical company, perform batch quality testing and prepare documentation for batch release, develop regulatory and recording documentation for the manufacture of medicinal products.
Competences
1.Ability to organise and ensure GMP-compliant manufacturing of medicinal products; ability to assess risks in the manufacturing of medicinal products and to follow procedures within the scope of personal competence; ability to understand the role of different analytical methods and apply them to the analysis of pharmaceutical products; ability to understand the relative importance of quality control testing and manufacturing monitoring in ensuring product quality.
Assessment
Individual work
|
Title
|
% from total grade
|
Grade
|
|---|---|---|
|
1.
Individual work |
-
|
-
|
|
Individual work – preparing presentations according to the topics of the study course.
In order to evaluate the quality of the study course as a whole, the student must fill out the study course evaluation questionnaire on the Student Portal.
|
||
Examination
|
Title
|
% from total grade
|
Grade
|
|---|---|---|
|
1.
Examination |
-
|
-
|
|
• solving situations independently during practical classes (50%);
• final examination – solving situations (50%).
|
||
Study Course Theme Plan
FULL-TIME
Part 1
-
Lecture
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Auditorium
|
2
|
Topics
|
EU Guidelines to Good manufacturing practice of Medicinal products for Human and Veterinary use.
|
-
Lecture
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Auditorium
|
2
|
Topics
|
EU Guidelines to Good manufacturing practice of Medicinal products for Human and Veterinary use. Annexes – 1st part.
|
-
Lecture
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Auditorium
|
2
|
Topics
|
EU Guidelines to Good manufacturing practice of Medicinal products for Human and Veterinary use. Annexes – 2nd part.
|
-
Lecture
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Auditorium
|
2
|
Topics
|
EU GMP Basic Requirements for Active Substances used as Starting Materials
|
-
Lecture
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Auditorium
|
2
|
Topics
|
Design in industrial pharmacy (buildings, facilities, equipment). Part 1.
|
-
Class/Seminar
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Laboratory
|
2
|
Topics
|
Design in industrial pharmacy (buildings, facilities, equipment). Part 2.
|
-
Class/Seminar
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Laboratory
|
2
|
Topics
|
Staff, recruitment, types and principles of training. Development of staff training programmes.
|
-
Class/Seminar
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Laboratory
|
2
|
Topics
|
Staff, recruitment, types and principles of training. Development of staff training programmes.
|
-
Class/Seminar
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Laboratory
|
2
|
Topics
|
Introductory instruction. Fire safety.
|
-
Lecture
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Auditorium
|
2
|
Topics
|
Cabinet of Ministers Regulations No. 304.
|
-
Class/Seminar
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Laboratory
|
2
|
Topics
|
Design in industrial pharmacy (buildings, facilities, equipment). Project chapters – from idea to implementation.
Control questions on the topic of design in industrial pharmacy (buildings, facilities, equipment). Recruitment. Interviews.
|
-
Class/Seminar
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Laboratory
|
2
|
Topics
|
Staff training.
|
-
Lecture
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Auditorium
|
2
|
Topics
|
Quality management system in a pharmaceutical company.
|
-
Lecture
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Auditorium
|
2
|
Topics
|
The role and responsibilities of the qualified person in a pharmaceutical company. Part 1.
|
-
Class/Seminar
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Laboratory
|
2
|
Topics
|
The role and responsibilities of the qualified person in a pharmaceutical company. Part 2.
|
-
Class/Seminar
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Laboratory
|
2
|
Topics
|
The role of audits in manufacturing. Internal audit. Classification of non-compliance.
|
Total ECTS (Creditpoints):
3.00
Contact hours:
32 Academic Hours
Final Examination:
Exam (Written)
Bibliography
Required Reading
1.
EudraLex The Rules Governing Medicinal products in the European Union. EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use, 2010 (akceptējams izdevums)
2.
LR MK noteikumi nr. 376. “Zāļu reģistrēšanas kārtība“
3.
LR MK noteikumi Nr. 304
4.
European Directorate for the Quality of Medicines and Healthcare. 2019-2021. European pharmacopoeia. 10th ed. Strasbourg: Council of Europe.
5.
Florence, A. T. 2016. Physicochemical principles of pharmacy: In manufacture, formulation and clinical use / Alexander T. Florence and David Attwood. 6th ed. London: Pharmaceutical Press. Available from: via Ebook Central (ProQuest)
6.
Fox, S. C. 2014. Pharmaceutics / Shelley Chambers Fox. 1st ed. London: Pharmaceutical Press. Available from: via Ebook Central (ProQuest).
7.
Jones, D. 2016. Pharmaceutics - dosage form and design / David Jones. Second ed. London: Pharmaceutical Press.
8.
Ārvalstu studentiem/For international students:
9.
EudraLex The Rules Governing Medicinal products in the European Union. EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use, 2010 (akceptējams izdevums)
10.
European Directorate for the Quality of Medicines and Healthcare. 2019-2021. European pharmacopoeia. 10th ed. Strasbourg: Council of Europe.
11.
Fox, S. C. 2014. Pharmaceutics / Shelley Chambers Fox. 1st ed. London: Pharmaceutical Press. Available from: via Ebook Central (ProQuest).
12.
Jones, D. 2016. Pharmaceutics - dosage form and design / David Jones. Second ed. London: Pharmaceutical Press.
Additional Reading
1.
Eiropas Zāļu Aģentūras (EMA) izdotas vadlīnijas skat. www.ema.europa.eu
2.
ICH Harmonised Tripartite Guidelines
3.
Ārvalstu studentiem/For international students:
4.
ICH Harmonised Tripartite Guidelines