After The Trial, BPOM Ensures Good Quality Of Merah Putih Vaccine

Maya Agustina/Photo: Antara

JAKARTA - The Food and Drug Supervisory Agency (BPOM) ensures and oversees the development of the Merah Putih vaccine so that it is of good quality, safe, efficacious, high quality, and competitive.

"BPOM monitors the efficacy, safety, and quality of vaccines," said Deputy for Control of Drugs, Narcotics, Psychotropics, Precursors and Addictive Substances BPOM Maya Agustina Andarini in the National Health Resilience Webinar: Development of Merah Putih Vaccines in Jakarta, Wednesday, March 16.

BPOM is committed to providing assistance to domestic vaccine production for any vaccine, including the COVID-19 vaccine, because independent vaccines are very important to answer the nation's needs and stop dependence on outside parties as vaccine suppliers.

"We want the vaccines produced in Indonesia to be of good quality and can also be used by other countries," Maya said as quoted by Antara.

If Indonesia is able to make its own COVID-19 vaccine, then Indonesia can become a reference for other countries in the research and development of vaccines so that vaccines can be used in the community.

"Because there is this pandemic, everyone is moved that we must be independent in the field of vaccines and we are of course very supportive," said Maya.

To ensure vaccine quality, BPOM refers to international standards and regulations and continues to prioritize the safety, quality, and efficacy of vaccines even though the current need for a COVID-19 vaccine is urgent.

"We remain strict with international standards in conducting the evaluation, especially the evaluation of the distribution permit," she said.

Maya said BPOM would provide assistance in vaccine research and development, clinical trials, and supervision from production to distribution and service facilities.

BPOM also encourages the acceleration of compliance with the requirements for Good Manufacturing Practices (GMP) for vaccine production.

"Of course we are strengthening cross-sectoral coordination in the preparation of regulations for evaluating protocols and research results and we are also issuing guidelines that serve as references for researchers and business actors to meet the requirements at their facilities," she said.

BPOM conducts competency improvement through GMP training workshops for GMP I and II research and training institutions with specific topics on calibration and equipment qualification, technical guidance on the preparation of Corrective Action and Preventive Action (CAPA).

In addition, BPOM conducts field visits or visits to production facilities aimed at identifying the fulfillment of requirements and verification of the condition of production facilities as well as discussions to evaluate related documents.