CANSINOBIO (06185) has announced that its production facility for the ACYW135 Group Meningococcal Polysaccharide Conjugate Vaccine (CRM197 carrier) (MCV4) and the 13-valent Pneumococcal Polysaccharide Conjugate Vaccine (CRM197/Tetanus Toxoid) (PCV13i) has successfully passed a Good Manufacturing Practice (GMP) compliance inspection conducted by the Malaysian National Pharmaceutical Regulatory Agency (NPRA) under the Pharmaceutical Inspection Co-operation Scheme (PIC/S). The company recently obtained the GMP certificate from the NPRA. PIC/S is an authoritative international organization for drug inspection and certification, comprising regulatory authorities from dozens of countries. It conducts inspections and certifications based on unified GMP standards for both human and veterinary pharmaceuticals. GMP compliance is a prerequisite for drug registration and market approval. On a voluntary basis, PIC/S member states and participating agencies mutually recognize GMP compliance certifications. Securing the PIC/S GMP certification demonstrates that the company's production and quality management systems meet PIC/S GMP standards, which will facilitate the drug registration and market launch processes for MCV4 and PCV13i in Malaysia and other PIC/S member countries.
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