The aim of studying and bibliography

The main aim of study: Acquiring knowledge on the laws and regulations related quality management in the pharmaceutical industry, i. e. assessment of the various stages of manufacture of the medicinal product.

The general information about the module: The module takes place in the sixth semester, includes 15 hours of lecture and 15 hours laboratory. The module ends with a final test.

Teaching materials: Instrukcje laboratoryjne

Bibliography required to complete the module

Bibliography used during lectures

1	Ustawa z dnia 6 września 2001 r. Prawo farmaceutyczne z późniejszymi zmianami		.
2	Ustawa o Urzędzie Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych		.
3	Farmakopea Europejska (PhEur)		.
4	Farmakopea Polska		.
5	Dyrektywa 2001/83/WE Parlamentu Europejskiego i Rady z dnia 6 listopada 2001 r. w sprawie wspólnotow		.
6	M. Zając, A. Jelińska	Ocena jakości substancji i produktów leczniczych: podręcznik dla studentów farmacji	Wydaw. Nauk. Uniwersytetu Medycznego im. Karola Marcinkowksiego, Poznań.	2010

Bibliography used during classes/laboratories/others

1	Aktualne rozporządzenie Ministra Zdrowia w sprawie wzoru zezwolenia na wytwarzanie produktu lecznicz		.
2	Aktualne rozporządzenie Ministra Zdrowia w sprawie wzoru wniosku o wydanie zezwolenia na wytwarzanie		.
3	Aktualne rozporządzenie Ministra Zdrowia w sprawie wzoru wniosku o zmianę zezwolenia na wytwarzanie		.
4	Aktualne rozporządzenie Ministra Zdrowia w sprawie sposobu przedstawiania dokumentacji dołączanej do		.
5	Aktualne rozporządzenie Ministra Zdrowia w sprawie wzoru wniosku o wydanie pozwolenia na dopuszczeni		.
6	Aktualne rozporządzenie Ministra Zdrowia w sprawie dokonywania zmian w pozwoleniu i dokumentacji dot		.
7	Aktualne rozporządzenie Ministra Zdrowia w sprawie wymagań Dobrej Praktyki Wytwarzania.		.
8	Aktualne rozporządzenie Ministra Zdrowia w sprawie wymagań dotyczących oznakowania opakowań produktu		.
9	Aktualne rozporządzenie Ministra Zdrowia w sprawie określenia szczegółowych zasad i trybu wstrzymywa		.
10	Aktualne rozporządzenie Ministra Zdrowia w sprawie wymagań, jakim powinna odpowiadać osoba wykwalifi		.
11	Aktualne rozporządzenie Ministra Zdrowia w sprawie kontroli seryjnej wstępnej		.

Basic requirements in category knowledge/skills/social competences

Formal requirements: semester registration Completed course analytical chemistry, instrumental analysis, basic knowledge of physical chemistry and organic

Basic requirements in category knowledge: No prerequisites required.

Basic requirements in category skills: Has skills in preparing of the documentation and computer skills

Basic requirements in category social competences: Understands the need for learning and working in team.

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	Knows the general principles of quality management throughout the supply chain in the pharmaceutical industry.	lecture	written test	K_W12++ K_K01+	P6S_KK P6S_WK
02	Has basic knowledge of the work of the Quality Assurance and Quality Control department in the pharmaceutical industry.	lecture	written test	K_W05++ K_U02+++ K_U11+	P6S_UK P6S_UW P6S_WG
03	Has knowledge about the preparation of documentation related to the registration dossier of a medicinal product, preparation of batch documentation, preparation of a product quality review report.	lecture	written test	K_W12+ K_U02+ K_K01++ K_K02+	P6S_KK P6S_KO P6S_KR P6S_UK P6S_WK
04	Knows the forms of the medicinal product, the main technological aspects.	lecture	written test	K_W02++ K_W05++	P6S_WG
05	Has knowledge of active substances and their quality assessment.	lecture	written test	K_W02++ K_W05+	P6S_WG
06	Has a basic knowledge of reasons for complaints and withholds/withdrawals of medicinal products from the market.	lecture	written test	K_W12+ K_U11+	P6S_UW P6S_WK
07	Has knowledge about raw materials and their technological functions.	lecture	written test	K_W12++ K_U02+ K_K01+	P6S_KK P6S_UK P6S_WK
08	Has knowledge of packaging materials used in the pharmaceutical industry.	lecture	written test	K_W12++ K_U02+ K_K01+	P6S_KK P6S_UK P6S_WK
09	Has a basic knowledge of the methods of controlling the finish products at the release stage and for stability studies.	lecture	written test	K_W12++ K_U02+ K_K01+	P6S_KK P6S_UK P6S_WK
10	Has a basic knowledge of validation. Has basic knowledge of the program of continuous testing of the stability of a medicinal product.	lecture	written test	K_W12++ K_U02+ K_K01+	P6S_KK P6S_UK P6S_WK
11	Knows the basic analytical methods used in the evaluation of the pharmacokinetics of drugs.	laboratory exercises	written test, written report, performance observation	K_W12++ K_U02+ K_K01+	P6S_KK P6S_UK P6S_WK
12	Has a knowledge of preparation and evaluation of a documentation realting to registration of a medicinal product (i), preparation and evaluation of a batch documentation (ii), preparation of product quality report (iii) and qualitative and quantitative complaint\\\'s investigation proces (iv).	laboratory exercises	written test, written report, performance observation	K_W12+ K_K01++ K_K02+	P6S_KK P6S_KO P6S_KR P6S_WK

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
6	TK01	Introduction. General principles of quality management throughout the supply chain in the pharmaceutical industry, basic definitions of GLP, GMP.	W01-W02	MEK01 MEK02 MEK03
6	TK02	Quality Assurance and Quality Control - what they are responsible for. Types of quality documentation.	W03	MEK01 MEK02 MEK03 MEK06 MEK12
6	TK03	Drug form, part I. Basics of manufacturing technology. Control parameters.	W04-W05	MEK04 MEK05 MEK09
6	TK04	Dietary supplements, dermocosmetics.	W06	MEK04 MEK05 MEK07
6	TK05	Active substances - division and methods of control.	W07	MEK04 MEK05 MEK11
6	TK06	Excipients and their technological functions. Packaging materials used in the pharmaceutical industry.	W08	MEK07 MEK08
6	TK07	Assessment of the quality of medicinal products, analytical methods.	W09-W10	MEK11
6	TK08	Validation of analytical methods.	W11	MEK10 MEK11
6	TK09	Process validations.	W12	MEK10
6	TK10	Stability studies.	W13-W14	MEK09 MEK11 MEK12
6	TK11	Summary of lectures, additions, questions.	W15	MEK01
6	TK12	Determination of the identity and assey of drotaverine hydrochloride in the No-spa product by the UV method with statistical evaluation of the results. Evaluation of the similarity of the UV spectrum.	L01	MEK09 MEK11
6	TK13	Evaluation of the quality of the selected active substance according to the specification. Working with the pharmacopoeia.	L02	MEK09 MEK11
6	TK14	Determination of the assey of Mg and Ca salts by complexometric titration with a solution of 0.05 mol/l EDTA against the indicator in the Dicarbocalm product, together with the statistical evaluation of the results.	L03	MEK09 MEK11

The student's effort

The type of classes	The work before classes	The participation in classes	The work after classes
Lecture (sem. 6)		contact hours: 15.00 hours/sem.
Laboratory (sem. 6)	The preparation for a Laboratory: 3.00 hours/sem. The preparation for a test: 3.00 hours/sem.	contact hours: 15.00 hours/sem.	Finishing/Making the report: 6.00 hours/sem.
Advice (sem. 6)
Credit (sem. 6)

The way of giving the component module grades and the final grade

The type of classes	The way of giving the final grade
Lecture	Mark of the written test from the lectures – W1. The test mark depends on the score gained: 50,1-60%: 3.0 60,1-70%: 3.5 70,1-80%: 4.0 80,1-90%: 4.5 90,1-100%: 5.0
Laboratory	Average mark from test and written report from each exercise – W2
The final grade	Final mark: W = w 0,5 W1 + w 0,5 W2; w - weighting factor: w = 1,0 first term, w = 0,9 second term, w = 0,8 third term

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