GMPISO

GMPISO is an international standards program and certification framework designed to harmonize good manufacturing practices with ISO-based quality management systems. It aims to provide a unified approach for manufacturing sectors including pharmaceuticals, biotechnology, medical devices, food, and cosmetics, enabling consistent product quality and safety across borders and reducing regulatory fragmentation.

The governance structure consists of an international council, technical committees, and a network of national standards bodies and accredited certification bodies. Technical committees develop GMPISO Standards, mapping GMP concepts to ISO clauses (quality policy, risk management, supplier controls, documentation, change control, audits). The process emphasizes stakeholder consensus and periodic review to stay aligned with scientific advances and regulatory expectations.

Standards and certification: The core outputs are the GMPISO Standards (GPS), a suite of guidelines and requirements that supplement existing GMP and ISO standards. Certification bodies accredited to GMPISO assess facilities through audits, documentation checks, and continued surveillance. Certifications indicate conformity to GPS and are designed to be mutually recognized among participating jurisdictions to support international trade.

Adoption and impact: GMPISO has been proposed and is pursuing pilots in multiple regions, and is seeking broader adoption through partnerships with industry associations and regulators. Proponents highlight improvements in product safety, traceability, and recalls reduction, while critics note the costs and complexity of cross-border certification. The initiative continues to refine alignment with ISO 9001, ISO 13485, and sector-specific standards, with ongoing efforts toward global interoperability and digitization of compliance records.