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Principles of quality control of
registered medicines, non-
registered medicines and
counterfeits of medical products
Jean-Marc Spieser,
Head of Department of Biological Standardisation, OMCL
Network & HealthCare (DBO),
EDQM/ Council of Europe, Strasbourg

Content
• EDQM – General Background
• Legal environment of registered medicines
• Tools available for the quality control of registered medicines
• The case of non-registered medicines and their vast
environment
• How to control non-registered products
• Counterfeits of medical products
• How, why, and where it happens
• How to control it

Jean-Marc Spieser, 23/09/09
©2009 EDQM, Council of Europe, All rights reserved 2

The Council of Europe
– Founded in 1949
– Development of European common and democratic
principles
– 47 member countries
– Strasbourg


The Council of Europe
– Founded in 1949
– Development of European
common and democratic
principles
– 47 member countries
– Strasbourg

European Convention on Human Rights
(protection of individuals) &
European Court of Human Rights


The European Union


EDQM - Short History
1964:
– Convention on the Elaboration of a European
Pharmacopoeia signed by 8 Member States
1992:
– 1st co-operation contract with the EU Commission on the
Biological Standardisation Programme
1994:
– European Community signs the Convention
– CEP – Implementation of the “Certification of Suitability
scheme”
– Official Medicines Control Laboratory (OMCL) – Creation of
the Network

Short History
Change of name: the Secretariat of the
European Pharmacopoeia becomes the
European Department (and later
“Directorate”) for the Quality of Medicines
(and later “& HealthCare”)…


Progressive Transfer of Activities
2007 – Blood Transfusion and Organ
Transplantation
2008 – Pharmaceuticals and Pharmaceutical

Care (general pharmaceutical
activities)
2009 – Cosmetics and Food Packaging

Ph.Eur.+ Eur. Observers


In the World


European Directorate for the Quality of
Medicines & HealthCare (EDQM)
Mission: to contribute to the basic human right
of access to good quality medicines
and healthcare

Health is a social human right indispensable
for the exercise of all other human rights, for
prosperity and democratic stability of people
in Europe


European Directorate for the Quality of
Medicines & HealthCare


European Regulatory Network
European Authorities
European Union
European Union

European
Council Parliament Medicines Agency
Commission EMEALondon
DG Entreprise
Brussels
Council
of Europe Pharmaceuticals
EuropeanDirectorate Ph. Eur.**
Pharmaceutical care
for the Quality
*OMCL :Official Medicines Control of Medicines & HealthCare
Laboratories Blood Transfusion Certification***
**Ph.Eur : European Pharmacopoeia
***Certification : Certification of Suitability EDQM
of Monographs of the European
Pharmacopoeia Organ Transplantation Strasbourg OMCL*
Network

Quality Assurance
Quality is obtained through the combination of:
• Definition and concept of the product based on development
work
• Good manufacturing processes steadily under control
- starting, in-process and final controls
- continuous optimisation
- VALIDATED controls of the final product based on
suitable and appropriate limited testing (necessary and
fully sufficient),
All the above should be totally traceable


Quality Assurance
As a general concept

QUALITY
is manufactured and not only
controlled


Quality Control
QC Principles
• Laboratory of high quality
 Good equipment: validated, regularly
maintained
 Good reagents
 Good operators


Quality Control
QC Principles
• Working environment
 QA/QMS in place
 Good reporting
 Procedures
 PTS
 Follow up and corrective actions
 Procedures in place
 Training

Regulations
• Medicines are submitted to very strict
regulations
• Each individual preparation requires a
Marketing Authorisation (MA)


Regulations
A fully detailed registration dossier is filed
based on:
Quality – Production using appropriate
process, suitable ingredients controlled and
released by validated tests
Safety - toxicology and pharmacology
Efficacy – clinical


Regulations
All information and documentation
compiled by producers and/or authorised
importer are filed to Health Authorities in
accordance with legal procedures and
assessed by experts using defined rules
 Official Authorisation


Regulations
• The product is continually assessed
throughout its lifetime:
 Inspections
 Controls
through laboratory testing
 Pharmacovigilance

If non-conformities are found  administrative, legal
and/or financial penalities


Tools
• The MAA: QA part
• CTD part
• Pharmacopoeias such as National Pharmacopoeias, International
Pharmacopoeias, Ph. Eur., USP
- General Chapters
- Individual Monographs
• Guidelines/ aide mémoire for inspections, sampling
• Literature/ data


Sampling
• Ensure representativity
- withdrawn by authority or mandated persons
- not by manufacturer
- define place where samples are taken, how and how much

• Ensure good storage
- temperature
- humidity
- transportation


Non registered “medicines”
• Traditional origin
- Mostly oral and very restricted data available
- Origin not always traceable but should be
- How to control the claims and attributes given to these
products
- What to control, which criteria and indicative parameters

• Legal environment??


• Controls
- Based on visual recognition of the substance or the plant
- If plant is chopped or ground use of of organoleptic
properties, microscopic aspect and basic wet chemistry(test
tube ) assays
- Important to verify that the right species is there
- Need of specialists


• Controls
- Based on traditional knowledge
- Sometimes described in literature bust mostly oral
- No official standards but need to develop it in known
recognised compendia

- Be carefull on adulterated, counterfeits
- ILLEGAL


COUNTERFEITED MEDICINES
• By definition not known
• When and where it will happen

- ILLEGAL of course by defition

- 2 basic areas attacked
- Blockbusters, expensive, well known, attractive…….organised crime
- Local , smallsmugglers for small quantities of every possible things


• How to combat these products
- Through multisectorial surveillance
- Forensic analysis
- Custom vigilance
- Police controls


• To start with
– Visual check of packaging very important

• Followed by analysis
– Simple and more and more sophisticated

• Need to have comparator
– Reference substance(s)
– Authentic samples


• Simple comparative tests

• Then sophisticated
– HPLC using different detectors, coupled with mass spectrum

• Usefulness of network


Thank you!

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