Quality Assurance in Medicines

Quality Assurance in Medicines

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Description: Main tasks of supervision over conditions of commercial production, pharmacy manufacture, sale, storage, transportation and medical use in health care organisations of MP are prevention of coming into circulation and timely withdrawal from circulation of LOW-GRADE and COUNTERFEIT MP, their destruction or return to the manufacturer or the supplier in order to provide the population and public health organisations with safe, efficient and quality MP.

 
Author: Anastasiya Sladkova PhD, Natalya Loginova PhD  | Visits: 447 | Page Views: 586
Domain:  Medicine Category: Biotech/Pharma 
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Contents:
LOGO
Drug Chemistry and Technology Basics,
Cleaner Production and Mega-Trends in Pharmaceutical Industry

Quality Assurance in Medicines

Dr. As. Prof. Anastasiya Sladkova
Dr. Sci. Prof. Natalya Loginova

1

Questions
1. Are there any differences between counterfeit drugs and
substandard drugs? Which type is more dangerous in your
opinion?
2. Define counterfeit medicine and discuss how it can be
identified
3. How can the production and marketing of counterfeit
medicines be stopped?
4. *Drug abuse is considered a major social problem. What
types of drugs are normally abused? Give a couple of
examples from each type
2

LECTURES
1. Introduction
2. Terminology of Drugs
3. Drug Design and Quality standards
4. Falsification of Medicines
5.

Quality Assurance in Medicines

6. Control by Pharmacopeias
7. Trends in Pharmaceutical Industry
3

Quality Assurance in
Medicines
The development, production and use of drugs is controlled by the state
Authorized agencies of the state implement the state policy in the field of
circulation of drugs by means of:


state registration of medicinal products



licencing of pharmaceutical activity



medicinal product quality control system



pharmacovigilance system



supervision over conditions of commercial production, pharmacy manufacture,

sale, storage, transportation and medical use in health care organisations of medicinal
products


withdrawal from circulation of low-grade and counterfeit medicinal products



exercise of other functions provided for by the legislation of the state

4

Authorized Agencies
The European Medicines Agency (EMA) is a European
Union agency for the evaluation of MP
Prior to 2004, it was known as the European Agency for the Evaluation of
MP (EMEA)

The Food and Drug Administration (FDA or USFDA) is
a federal agency of the United States Department of Health
and Human Services.
The FDA is responsible for protecting and promoting public health through
the regulation and supervision of food safety, tobacco products, dietary
supplements, drugs (medications), vaccines, biopharmaceuticals, blood
transfusions, medical devices, cosmetics etc.
5

Quality Assurance in
Medicines
Fundamental principles of the state policy in the field of
medicinal product (MP) circulation:
 state regulation of the medicinal product circulation;
 availability of medicinal products;
 support to and development of international

cooperation

6

Availability of Medicinal
Products
… an essential condition for provision of the population with

timely medical assistance
The state shall ensure availability of MP by means of:

 the most complete saturation of the internal market
with safe, effective and quality MP, in the first place
those included in the list of main medicinal products
 improvement of the MP distribution system
7

State Registration of
Medicinal Products
MP may be produced, sold and used

in the territory of the state after their
state registration (confirmation of state registration)
… the procedure for recognition of the MP compliance with the

requirements to its safety, efficiency and quality conducted for
the purpose of permission of the commercial production,
sale and medical use of the MP manufactured in the state,

as well as sale and medical use of the MP supplied from
abroad
8

State Registration of
Medicinal Products
State registration IS NOT REQUIRED for:
 MP manufactured in pharmacies
 MP intended for use as exhibition samples
 MP intended for conduct of non-clinical studies and clinical trials
 MP brought to the territory of the state by a natural person for
personal needs
 MP intended for commercial production for export only
 pharmaceutical substances, if the master files for MP that have
such pharmaceutical substances in their formulation contain documents
issued by manufacturers of these pharmaceutical substances
complying with the requirements set for the documents being a part of
the master file
9

State Registration of
Medicinal Products
Medicinal

plant

raw

materials

are

subject

to

state

registration as a medicinal product after passing the stage of
production process of creation of a certain dosage form
State registration (confirmation of state registration) of
medicinal products is carried out by authorized agencies of
the state

For state registration (confirmation of state registration) of a
medicinal product the applicant submits the master file
(registration dossier)
10

The Master File
… documents submitted by the applicant for state

registration (confirmation of state registration) of the
MP and constraining information about safety,
efficiency and quality of the MP, as well as about the
posted price of the MP, other documents defined by
authorized agencies of the state
11

The Marketing Authorisation
A registered MP is entered into the State Register of MP
Marketing authorisation with a 3‒5 year validity period is
issued for the MP registered in the state for the first time
Marketing authorisation – a document issued for the MP

based on the results of the conducted state registration
(confirmation of state registration)
Registration number – a coded identification assigned to the

MP based on the results of the state registration
12

The Marketing Authorisation
Upon expiration of the marketing authorisation validity the MP must pass

the procedure of confirmation of state registration
Validity of the marketing authorisation IS CANCELLED in the following
cases:
 expiration of validity of the marketing authorisation issued for the
term of 3‒5 years
 non-elimination, by the applicant, of circumstances that entailed
suspension of the marketing authorisation
 the applicant’s refusal to conduct clinical trials of the MP
prescribed by the authorized agency
 the applicant’s submission of application for termination of the
marketing authorisation
In case of any changes in the information contained in the documents
included in the master file the master file is amended accordingly
13

The medicinal product quality
control system
The quality of the MP of domestic manufacture is determined by
its compliance with:
 the requirements
monograph


of

the

manufacturer’s

pharmacopoeial

pharmacopoeial monographs of the State Pharmacopeia

The quality of the MP of foreign manufacture is determined by the
compliance with:
 the requirements of the regulatory document of its manufacturer
containing the indicators and methods used for quality control of the
MP (the manufacturer’s regulatory document)

The quality of MP manufactured in pharmacies is determined by
their compliance with:


the requirements of the State Pharmacopeia

14

The medicinal product quality
control system
The MP of domestic manufacture non-complying with

the requirements of the manufacturer’s pharmacopoeial
monograph, pharmacopoeial monographs of the State
Pharmacopeia,

as

well

as

the

MP

of

foreign

manufacture non-complying with the requirements of
the manufacturer’s regulatory documents are recognized
as LOW-GRADE
15

Quality of a Medicine
… is compliance of a medicine with the requirements of the

pharmacopoeia monograph or, in case of non-availability of the
latter, of the normative documentation or normative document
Normative documentation is a document containing a list of

quality characteristics and quality control methods for a medicine for
medical use as determined under the relevant expert examination
results, established by the manufacturer

Drug quality standard ‒ a normative document containing a list of
regulated indicators (quality characteristics, critical indexes,
quality indexes, Q-factors) and methods of quality control of drugs
16

Drug quality standards
Drug quality standards:
1. State Pharmacopeia

2. pharmacopoeial monograph
3. the manufacturer’s pharmacopoeial monograph

4. state standard

17

Drug quality standards
Each batch of the registered MP before being placed into sale,
as well as medicinal products available in circulation are
subject to quality control in testing laboratories accredited
in the accreditation system of the state for the purpose of
MP tests

In Belarus:
The Center for Examinations and Tests in Health Service
State Enterprise http://www.rceth.by/en
18

The pharmacovigilance
system
… a set of measures aimed at timely detection of all changes
in the risk and benefit ratio of the MP, as well as at
minimisation of negative consequences of their use
… supervision during a fourth step of clinical trials
(connected with GPP)
MP manufacturers, as well as medical and pharmaceutical
officers must provide information about detected adverse
reactions, including side reactions, of the MP in accordance

with the procedure defined by the authorized agencies
19

The pharmacovigilance
system
Main tasks of supervision over conditions of commercial
production, pharmacy manufacture, sale, storage,
transportation and medical use in health care organisations of
MP are prevention of coming into circulation and
timely withdrawal from circulation of
LOW-GRADE and COUNTERFEIT MP, their destruction or
return to the manufacturer or the supplier in order to provide
the population and public health organisations with
safe, efficient and quality MP
20

LOGO

sladkova-an@yandex.ru