WestVac Biopharma Obtains PIC/S GMP Certification from Mexico
2024-01-24
Recently, WestVac Biopharma has received the GMP (Good Manufacturing Practice) certificate from the Federal Commission for Protection against Health Risks (COFEPRIS) in Mexico, a member of the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S). This certification covers all the COVID-19 vaccines produced by WestVac Biopharma using insect cells (Sf9), including the Recombinant COVID-19 Trivalent (XBB+BA.5+Delta) Protein Vaccine (Sf9 Cell) and other COVID-19 vaccine series.
PIC/S was established in November 1995. Currently, its members include more than 40 countries and regions such as the United States, Mexico, the United Kingdom, France, Germany, South Africa, Japan, South Korea, Australia, etc. Its aim is to implement the unified standards for pharmaceutical Good Manufacturing Practices (GMP) certification. Based on voluntary participation, member countries mutually recognize official GMP certification reports to reduce non-tariff trade barriers in the circulation of medicines. PIC/S GMP is one of the most rigorous GMP specifications worldwide. Therefore, implementing PIC/S GMP can further improve the quality of pharmaceutical products and ensure medication safety.
COFEPRIS of Mexico is one of the members of the PIC/S. Its GMP certification involves various aspects of vaccine production quality management, with a particular focus on the management and implementation of various types of validation, documentation, and records for product quality control. The inspection standards are high, the inspection duration is long, and the difficulty level is significant. Experts from COFEPRIS have comprehensively examined and assessed the production quality management system and vaccine supply capabilities of WestVac Biopharma, including the preparation and storage of strains and cells, material management, utility system operation, verification and validation, production management, quality management, aseptic assurance, and finished product cold chain transportation. After thorough evaluation, it has been determined that the production quality management system of WestVac Biopharma runs smoothly, ensuring continuous and stable supply of safe and effective COVID-19 vaccine products and meeting Mexico's needs for COVID-19 prevention and control. As a result, COFEPRIS has granted GMP certification to WestVac Biopharma.
Obtaining the COFEPRIS GMP certification in Mexico will help WestVac Biopharma to obtain registration and market authorization for its recombinant protein COVID-19 vaccine series products in many countries worldwide, contributing the strength of WestVac Biopharma to the global fight against the COVID-19 pandemic. It also lays a solid foundation for WestVac Biopharma to go from China to the rest of the world relying on its future innovative vaccines and immunotherapies.
The Recombinant COVID-19 Trivalent (XBB+BA.5+Delta) Protein Vaccine (Sf9 Cell), known as Coviccine® Trivalent XBB Vaccine, is a new generation of broad-spectrum COVID-19 vaccine of high purity and high quality produced by WestVac Biopharma, taking advantage of the fast-response of the internationally advanced technology platform of recombinant protein vaccine production from insect cells. This vaccine was granted emergency use approval by relevant national departments in June 2023 and has been administered free of charge in more than 300 cities and over 10,000 community vaccination sites nationwide through multiple rounds of vaccinations.
