In the effort to re-establish the vaccine production in the country, the Vaccine Self
Sufficiency Project was conceptualized (see feature report). Operationally, this project
will be implemented in phases. Phase 1 will establish the following units: BCG and
Antivenin vaccine production plant, Quality Control Laboratory, Air handling Utilities,
Power Plant, Storage and Packaging.
The BCG vaccine was included in the first phase of Biological
Production Division facility because good quality BCG vaccine had been successfully
produced in the past. BCG production will form the nucleus from which all other vaccines
will be produced. Antivenin, specific against Philippine cobra venom, is another vaccine,
which is being produced in the BPS laboratory. Antivenin will be upgraded into GMP quality
in the new vaccine production facilities.
Phase 2 is the establishment of filling lines for the combination
vaccine (DPT, HVB and Hib), Tetanus toxoid and anti rabies will be included in this phase.
Only filling lines and separate air handling facilities will be added. Water utilities and
warehouse facilities have already been established in Phase 1. The plant was subcontracted
to Pharmadule of Sweden and are certified by the Swedish Food and Drug Authority in
December 2000. At the final stage of re-assembly at RITM, the National Control Laboratory
for Vaccines at Bureau of Food and Drugs, Department of Health, which was established to
serve as the external quality control and assurance for all vaccines produced at RITM,
have been involved at the outset.