|
European
Committee
for
Standardization
(CEN)
http://cenorm.de
Draws up
voluntary
European
Standards
and promotes
corresponding
conformity
of products
and services
in, for
example,
analytical
laboratories.
_______________________________________
Guide to
quality
systems for
medical
laboratories..
http://www.who.int/dsa/cat98/lab8.htm#Quality
System for
Medical
Laboratories
A
comprehensive
guide to
both the
principles
and specific
procedures
involved in
the quality
control of
medical
laboratories.
Addressed to
managers as
well as
laboratory
staff, the
manual
concentrates
on the many
methods
available to
provide
safe,
accurate,
and
reproducible
measurements
and
observations.
The
importance
of adhering
to
formalized,
written
procedures
is
repeatedly
emphasized.
_______________________________________
•
Guidelines
for
Evaluating
and
Expressing
the
Uncertainty
of NIST
Measurement
Results
•
ASTM's
Statistical
Quality
Assurance
Programs
•
AASHTO
Materials
Reference
Laboratory
Proficiency
Sample
Program
_______________________________________
•
Bio Pharm
Magazine
•
Journal of
GXP
Compliance
•
Journal of
Validation
Technology
•
Journal of
Pharmaceutical
Technology
•
Medical
Device
Diagnostic
Industry
Magazine
_______________________________________
•
ISO
(International
Organization
for
Standardization)
•
European
Directorate
for the
quality of
Medicines
•
European
Unions
Institutions
•
European
Agencies and
Bodies
•
EU national
authorities
for
medicinal
products for
human use
•
ESRA-European
Society of
Regulatory
Affairs
•
EU national
authorities
for
medicinal
products for
veterinary
use
•
FEDESA-European
Federation
of Animal
Health
•
Interpharma-Swiss
pharmaceutical
industry
•
European
Agency for
the
Evaluation
of Medicinal
Products
_______________________________________
•
U.S.
Department
of Health
and Human
Services
•
U.S.Food and
Drug
Administration
•
U.S. FDA
Center for
Biologics
Evaluation
and Research
•
U.S. FDA
Center for
Drug
Evaluation
and Research
•
U.S. FDA
Center for
Devices and
Radiological
Health
•
U.S.FDA
Office of
Regulatory
Affairs
•
U.S. FDA/ORA
Compliance
Refrences
|
