T/CNPPA 3006-2019 General Requirements for Hollow Capsules
T/CNPPA 3006-2019
Basic Information
Scope
Scope: This standard specifies the general principles, classification, naming, production quality management, applicability studies, stability, and packaging, storage, and transportation of hollow capsules. This standard applies to hollow capsules used in oral capsule preparations. Main technical content: This standard specifies the general principles, classification, naming, production quality management, applicability studies, stability, and packaging, storage, and transportation of hollow capsules. The capsules are reasonably classified according to the source of raw materials, the composition of film-forming materials, release characteristics, and transparency. It standardizes the naming principles and clarifies the production quality management requirements for hollow capsule production, including raw materials, process control, batch division, etc. It outlines the applicability studies and stability of hollow capsules, providing a reference for the development of capsule products. The requirements for storage, transportation, and packaging are described, ensuring the effective protection of capsules during storage and transportation.