ЗАТВЕРДЖЕНО
на засіданні кафедри,
протокол №_1__
від “29”_cерпня__2014 р.
CALENDAR AND THEMATIC PLAN
of laboratory works of “Standardization of drugs”
for the 5-th Year students of the Faculty of Pharmacy
(autumn semester of 2014/2015 educational year)
№
Topic
1.
The Law of Ukraine “About drugs”. General thesis.
2.
State policy and state management in sphere of creation, production, control of
quality and realization of drugs. Creation of drugs. Production of drugs. State
control of quality of drugs. Realization of drugs.
Decree of the Cabinet of Ministers of Ukraine "Standardization and Certification
of drugs". Purity, identity and assay of drug’s substance “Ungro” "Calcium
gluconate for injections" and it's satisfy to Pharmacopoeia's article SPhU 1-st
edition.
The WHO in system of security (guarantee) of medicines quality. Purity, identity
and assay of drug’s substance “Ungro” "Acidum ascorbinicum" and it's
accordance to Pharmacopoeia's article SPhU 1-st edition.
The principles and rules of the EU GMP and GMP WHO. Purity, identity and
assay of drug’s substance “Ungro” "Thiamini hydrobromidum aut
hydrochloridum" and it's accordance to Pharmacopoeia's article SPhU 1-st edition.
Strategy of Ukraine in the system of quality assurance of medicines. Purity,
identity and assay of drug "Tablets of Analginum 0,5" and it's accordance to
Pharmacopoeia's article PhA 42 У-11-265-97.
State pharmacopoeia of Ukraine. General terms. Purity, identity and assay of drug
"Tablets of Strepthocide 0,3" and it's accordance to Pharmacopoeia's article PhA
42 У-11-1001-00
Requirements for quality management, principles of quality assurance and good
manufacturing practice quality control. Purity, identity and assay of drug “Tablets
of Furaciline 0,02 to be taken externally” and it’s accordance to analytical –
normative documentation.
Requirements for Quality Control: Principles, general requirements.Purity,
identity and assay of drug "Sol. Calcii chloridi 10 % pro injectionibus" and it's
accordance to Pharmacopoeia's article PhA 42 У- 11-401– 98.
Requirements to the premises and equipment, to staff, documentation and
sampling. Purity, identity and assay of drug "Sol. Novocaine 0.5% for injections"
and it's accordance to satisfy to analytical – normative documentation
Control of medicines in Ukraine under current conditions.Purity, identity and
assay of drug "Sol. Nicotinic acid 1% for injections" and it's accordance to satisfy
to Pharmacopoeia's article PhA 42-26-63-89
Validation of analytical methods and tests.Purity, identity and assay of drug "Sol.
Euphilline 2,4 % for injections" and it's satisfy to Pharmacopoeia's article PhA 42
У-8-762-98.
The system of pharmacopeia reference standards of the State Pharmacopoeia of
Ukraine. Purity, identity and assay of drug "Sol. Papaverine hydrochloride 2% for
injections" and it's accordance to Pharmacopoeia's article PhA 42 У-7-98-96.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
Durati
on
2
04.09
2
11.09
2
18.09
2
25.09
2
02.10
2
09.10
2
16.10
2
23.10
2
30.10
2
06.11
2
13.11
2
20.11
2
27.11
14.
15.
16.
17.
18.
19.
20.
Total
Normative and technical documents regulating the quality of medicines. Research
and technological performance analysis of multi-powder formulations produced in
pharmacies by prescription doctors.
Documentation requirements, principles, general requirements. Study of the
technological parameters, analysis of multi-powder formulations produced in
pharmacies by prescription doctors
Regulatory documentation. Study and technological parameters analysis of multipowder formulations produced in pharmacies by prescription doctors
Requirements to the production: principles, general requirements. Study of
technological parameters; analysis of multi liquid products manufactured in
pharmacies by prescription doctors
Validation. Study of the technological parameters and analysis of multicomponent
liquid products manufactured in pharmacies by prescription doctors
Requirements to the finished product. Study of the technological parameters and
analysis of multicomponent liquid products manufactured in pharmacies by
prescription doctors
General test.
Head of pharmaceutical,
organic and bioorganic chemistry chair
Academician
2
04.12
2
11.12
2
18.12
2
25.12
2
08.01
2
15.01
2
40
22.01
B. S. Zimenkovsky