Syntagon successfully renews GMP accreditation

Specialist contract research organisation, Syntagon, has successfully renewed its Good Manufacturing Practices (GMP) certification for the manufacture of clinical active pharmaceutical ingredients (APIs) following an audit by the Swedish Medical Products Agency.

GMP compliance is an international requirement for the manufacture of medicinal products for human and veterinary use and helps maintain the quality and safety of medicinal products. “We are delighted to be successfully re-audited by the [Swedish Medical Products] Agency. It demonstrates our continued commitment to quality and our full compliance with GMP,” says Paul Alhadeff, Syntagon Quality Assurance Officer. The two-day audit scrutinised Syntagon’s facilities, documentation, Quality Control (QC) and Quality Assurance (QA) departments. The Agency, known as Läkemedelsverket in Sweden, carries out GMP audits every three years. Syntagon first gained accreditation from the Agency in 2003. The certification allows Syntagon to continue to make clinical APIs for clinical trials throughout Europe and North America. With operations in Sweden, Latvia, and China, Syntagon specialises in synthetic preparation of small molecules under GMP manufacture. Syntagon’s expertise in GMP manufacture, as well as analytical chemistry and crystallisation is tailored for all client types: from single-product start-ups, to global pharmaceutical groups.

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