T/CNPPA 3034-2026 Guidance of the performance testing for the transport packages of pharmaceutical products
T/CNPPA 3034-2026 Guidance of the performance testing for the transport packages of pharmaceutical products
Basic Information
Scope
Simulated transport tests typically include laboratory-simulated transport tests and simulated actual transport tests. Laboratory-simulated transport tests can subject packaging to a uniformly designed test process, which can be used to evaluate the ability of transport units to withstand transport environments, predict in advance whether transport packaging or systems will be damaged in actual circulation environments, determine the possible extent of damage, and identify the factors contributing to the damage. Simulated transport tests can not only be used to evaluate the actual performance of existing packaging, but also provide a basis for the design of product packaging and the development of packaging processes. This document provides the general procedures and test methods for simulated transport tests of pharmaceutical packaging, which are applicable to the development, distribution, and delivery processes of pharmaceutical packaging. The performance tests of pharmaceutical transport packaging can be based on potential risk decisions to determine whether to conduct relevant tests, or based on risk to formulate or adjust test plans. Therefore, effective risk identification plays an important role in the transport packaging tests of pharmaceuticals.