Stone Successfully Passes the Second On-Site Surveillance Audit for ISO 15378:2017

In March 2023, Guangdong Stone passed the second on-site surveillance audit conducted by Shanghai POSI Certification Co., Ltd. (POSI) and maintained its ISO 15378:2017 certification. This marked the second annual surveillance audit following the initial certification in 2021. While the first surveillance audit had been conducted remotely via video due to the impact of the pandemic in 2022—a method that imposed certain limitations—this on-site inspection allowed for a more objective and comprehensive assessment of the system’s operation. Over the past two years, Guangdong Stone has continuously improved in accordance with the quality system’s requirements, and the progress made in establishing the system was recognized by the audit experts.

The primary objective of ISO 15378 is to specify requirements for primary packaging materials for medicinal products. It incorporates specific requirements for these materials derived from Good Manufacturing Practices (GMP) applicable to the production and control of pharmaceuticals.