1. “BLIND-SPOTS” OF MEDICINE LIFE-CYCLE FROM THE POINT OF VIEW OF THE GOOD PRACTICES

2. Manufacturing, Marketing Pharmaceutical development
MEDICINE LIFECYCLE
Discovery ?
GCP
Phase I
Preclinical studies
Preclinical studies
Clinical studies
Approval
Phase IV
GLP
Manufacturing, Marketing
Post-approval studies
GMP
Phase II
Animal welfare ?
Phase III ?
Pharmaceutical development ?

3. GOOD PRACTICE IN FUNDAMENTAL STUDIES
≈20% of all preclinical
studies in Russia
HANDBOOK ON QUALITY PRACTICES IN
BASIC BIOMEDICAL RESEARCH (QPBR)
in vitro, in silico screening
Search for mechanisms of action
Pharmacological properties in vitro/in vivo
Pharmacokinetics
ADME TOX
Prior toxicity studies
Validation equipment
Study director
Controls
Quality Assurance
GLP-like
Study plans preparation
SOP
Reporting
documentation

4. Pre(“Non”)clinical stydies
ARE POST-APPROVAL STUDIES GLP or NON-GLP?
≈70% of all preclinical
studies in Russia
Changing composition of excipients
Changing manufacturing facility API
New efficient reception
Changing course of use
Establishing/evidence of the mechanism of action
Clarification of toxic properties
Adding the usage at pregnancy into instruction
BIOSIMILARS
GENERICS
Pre(“Non”)clinical stydies
HYBRID MEDICINES

5. LABORATORY ANIMALS Good animal welfare practice? Animal environment
Methods of euthanasia
Animal housing
Humanity
of manipulations
Feeding
and watering
RUS-LASA
Animal number
used in study
Enrichment
of living environment
Pain and stress

6. PHARMACEUTICAL DEVELOPMENT
Medicine compounds
Pharmaceutical dosage form
Manufacturing
Packaging materials
Choice of API (concentration, physical state and size of counts)
Choice of pharmaceutical dosage form
Technological methods
Choice of material types, size and package
Choice of excipients
Functional properties of a pharmaceutical dosage form
Functional properties of a commercial product
Establishing product expiration date into package
Solvents
Basis
Shells
Preservatives
Release modifiers
Parameters of
(PHARMACOPOEIA)
Biological activity
Stability
Sterility and etc.
Abnormal toxicity
GMP
ISO 17025
GLP

7. Quality Management Systems
QUALITY MANAGEMENT SYSTEMS COOPERATING
ISO 9001
Process-oriented Quality Management
GXP
Product-oriented Quality Management
GCP
GLP
GMP
GSP
ISO 17025
Quality Management Systems
ISO 9001

8. THANK YOU FOR LISTENING
188663, Ленинградская область ,
Всеволожский район, гп Кузьмоловский,
ул. Заводская, д. 3, к. 245