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

Bibliography used during lectures

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
01	He knows the legal basis for the preparation of a medicinal product	lecture	pass the oral part	K_W10+++	P6S_WG
02	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
03	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
04	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
05	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

Attention: Depending on the epidemic situation, verification of the achieved learning outcomes specified in the study program, in particular credits and examinations at the end of specific classes, can be implemented remotely (real-time meetings).

The syllabus of the module

Sem.	TK	The content	realized in	MEK
5	TK01	Basic requirements for the medicinal product. The legal basis of good manufacturing practice. Admission to trading. Manufacturing Authorisation.	W01-W02	MEK01 MEK04
5	TK02	State Pharmaceutical Inspection	W03	MEK01 MEK03
5	TK03	Generation and analysis on demand.	W04-W05	MEK02
5	TK04	Quality management.	W06-W08	MEK01 MEK03 MEK05
5	TK05	Staff. Training of staff.	W09-W10	MEK04
5	TK06	The organization of production. Environmental conditions. Water systems. Purified water.	W10-W11	MEK02
5	TK07	Audits. Poaudytowe activities.	W12-W13	MEK01 MEK05
5	TK08	Good practice in the laboratory. The organization of the quality control department. Documentation. Attempts reference.	W13-W14	MEK03
5	TK09	Validation.	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

The contents of the module are associated with the research profile: no