Item card
Basics of good manufacturing practice (GMP)
Some basic information about the module
Cycle of education:
2022/2023
The name of the faculty organization unit:
The faculty Chemistry
The name of the field of study:
Pharmaceutical engineering
The area of study:
technical/biological sciences
The profile of studing:
The level of study:
first degree study
Type of study:
full time
discipline specialities :
The degree after graduating from university:
Bachelor of Science (BSc)
The name of the module department :
Department of Technology and Materials Chemistry
The code of the module:
12703
The module status:
mandatory for teaching programme
The position in the studies teaching programme:
sem: 5 / W15 / 1 ECTS / Z
The language of the lecture:
Polish
The name of the coordinator:
Agnieszka Bukowska, DSc, PhD, Eng.
The aim of studying and bibliography
The main aim of study:
Getting to know the regulations and laws on good manufacturing practice - the strict control of all elements of production, at different stages of product development - medicine.
The general information about the module:
The module is carried out in the fifth semester - 15 hours of lectures.
Bibliography required to complete the module
| 1 | Ustawa z dnia 6 września 2001 r. Prawo farmaceutyczne (tekst jednolity Dz. U. z 2008 r. nr 45, pozy | - | -. | - |
| 2 | - | Rozporządzenie Ministra Zdrowia z dnia 1 października 2008 r. w sprawie wymagań Dobrej Praktyki Wytw | -. | - |
| 3 | - | Aneks 20 „Zarzadzanie Ryzykiem Jakości” | -. | - |
| 4 | - | EudraLex Volume 4 Goog Manufacturing Practise (GMP) Guidelines | -. | - |
| 5 | - | PN-EN ISO 9001:2009 | -. | - |
| 6 | - | PN-EN ISO 22000:2006 | -. | - |
Basic requirements in category knowledge/skills/social competences
Formal requirements:
Registration for the fifth semester.
Basic requirements in category knowledge:
There are no prerequisites
Basic requirements in category skills:
There are no prerequisites
Basic requirements in category social competences:
He understands the need for self-learning
Module outcomes
| MEK | The student who completed the module | Types of classes / teaching methods leading to achieving a given outcome of teaching | Methods of verifying every mentioned outcome of teaching | Relationships with KEK | Relationships with PRK |
|---|---|---|---|---|---|
| MEK01 | He knows the legal basis for the preparation of a medicinal product | lecture | pass the oral part |
K-W10+++ |
P6S-WG |
| MEK02 | It has a basic knowledge of quality management, implemented by the Quality Assurance System, which includes good manufacturing practice, quality control and risk management quality of the medicinal product | lecture | pass the oral part |
K-W10+++ |
P6S-WG |
| MEK03 | He has knowledge of the strict control of the production of the medicinal product, knowledge of the equipment and premises and the qualifications of the staff to carry out these tasks | lecture | pass the oral part |
K-W10++ K-W11+ |
P6S-WG P6S-WK |
| MEK04 | He knows the basic legal principles of pharmaceutical care and hygiene program in pharmaceutical plants, and knows the basic factors determining the safe organization of production | lecture | He knows the basic legal principles of pharmaceutical care and hygiene program in pharmaceutical plants, and knows the basic factors determining the safe organization of production |
K-W10++ K-U13+ |
P6S-UW P6S-WG |
| MEK05 | In view of the frequent modifications and changes in the regulations concerning the manufacture and placing the product on the market understands the need to improve their professional skills by tracking the introduction of new regulations | lecture | observation of performance |
K-U12+ K-K04+ |
P6S-KR P6S-UW |
The syllabus of the module
| Sem. | TK | The content | realized in | MEK |
|---|---|---|---|---|
| 5 | TK01 | W01-W02 | MEK01 MEK04 | |
| 5 | TK02 | W03 | MEK01 MEK03 | |
| 5 | TK03 | W04-W05 | MEK02 | |
| 5 | TK04 | W06-W08 | MEK01 MEK03 MEK05 | |
| 5 | TK05 | W09-W10 | MEK04 | |
| 5 | TK06 | W10-W11 | MEK02 | |
| 5 | TK07 | W12-W13 | MEK01 MEK05 | |
| 5 | TK08 | W13-W14 | MEK03 | |
| 5 | TK09 | W14-W15 | MEK01 |
The student's effort
| The type of classes | The work before classes | The participation in classes | The work after classes |
|---|---|---|---|
| Lecture (sem. 5) | contact hours:
15.00 hours/sem. |
complementing/reading through notes:
2.00 hours/sem. |
|
| Advice (sem. 5) | |||
| Credit (sem. 5) | The preparation for a Credit:
10.00 hours/sem. |
The oral credit:
1.00 hours/sem. |
The way of giving the component module grades and the final grade
| The type of classes | The way of giving the final grade |
|---|---|
| Lecture | Grade from the final test. Grading scale on the final exam sheet. |
| The final grade | The final grade is equal to the evaluation of the course |
Sample problems
Required during the exam/when receiving the credit
(-)
Realized during classes/laboratories/projects
(-)
Others
(-)
Can a student use any teaching aids during the exam/when receiving the credit : no