Local vaccine production accounts for the majority of all doses
of vaccines administered in developing countries. However, mechanisms
are often not in place in the producing countries to ensure
that the manufacturing facilities meet international standards
for vaccine production. In addition, independent and competent
National Regulatory Authority/National Control Laboratory (NRA/NCL)
are often not fully developed. These are necessary to provide
oversight for registration, post-marketing surveillance, lot
release, Good Manufacturing Practices (GMP) inspection, and
to establish and enforce appropriate regulations. Therefore,
one of IVI¡¯s most important mandates is to provide technical
assistance and training to both local manufacturers and NRA/NCL
to upgrade the production, regulation, and control of locally
manufactured vaccines. The goal of this program is to develop
the competence and requisite skills in vaccine manufacturing
and regulating practices critical to national needs and priorities.
The program includes the following sequential activities:
1. Vaccine manufacturers
GMP inspection for status analysis: To diagnose the status
of vaccine manufacturing facilities and operations, production
and quality control/assurance are assessed, and the specific
areas needing improvement to comply with GMP are determined.
Short-term introductory/implementation-oriented GMP training:
This course provides trainees with a platform of basic knowledge
on the principles and application of GMP.
GMP facility design: Technical assistance is offered in renovating
the facilities and/or designing new facilities in accordance
with the ¡°clean vs. dirty area¡± concept and ¡°infectious vs.
non-infectious area¡± concept.
Long-term extensive hands-on GMP training: This program provides
trainees with practical knowledge on the implementation of
GMP principles for the manufacture of vaccines. The program
focuses on three areas: production, quality control and quality
assurance.
Subsequent consultancies/training: Occasional short-term
visits to the vaccine manufacturers are made for further assistance
when needed.
2. NRA/NCL
Inspection for status analysis: To diagnose the status of
NRA/NCL, the agencies are assessed and the specific areas
to be improved are determined.
Introductory (Good Laboratory Practice) GLP/GMP training:
This course is to provide trainees with a platform of basic
knowledge on the principle and application of GLP/GMP.
Facility design: Technical assistance is offered in renovating
present facilities and/or designing new facilities.
Long-term hands-on training on quality control testings and
quality assurance is also available.
Occasional short-term visits to NRA/NCL are made for further
assistance when needed.
The above technical assistance and training are provided
primarily at local facilities. However when the IVI pilot
plant and laboratories are completed, the long-term hands-on
training will be performed at IVI.
During 2000, the IVI in collaboration with WHO/PAHO conducted
a training course for the NRA/NCL personnel in Brazil. This
training was organized by the Global Training Network (GTN)
of WHO, and IVI provided the training course as one of the
training centers of the GTN. The Korean Food & Drug Administration
has been continuously assisted by IVI staff in the field of
the evaluation, research and control of biologics including
vaccines and diagnostics. The IVI also provided introductory
GMP/QC/QA training courses and inspections/consultancies for
the Lanzhou Institute in China, and the National Institute
for Hygiene and Epidemiology and the Institute for Vaccines
and Serum in Vietnam. Finally, a status analysis was made
to plan for specific future assistance and training programs
for each institute.
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