T/ZJPA 001-2022 Active

Scope: This document provides technical guidance for on-site verification of the registration of oral controlled-release preparations and compliance with Good Manufacturing Practice (GMP) standards, describes the technical characteristics of oral controlled-release preparations, highlights the special risk points in the development, technology transfer, and commercial production processes, analyzes the critical quality attributes (CQAs) that may affect product effectiveness and safety, and elaborates on the inspection focus of oral controlled-release preparations that differ from conventional preparations in terms of materials, equipment and facilities, production processes, and quality control. Main technical content: 4. Overview of oral controlled-release preparations 4.1. Film-coated controlled-release preparations 4.1.1. Formulation process 4.1.2. Critical quality attributes 4.1.3. Supportive studies required 4.1.4. Special risks 4.2. Skeleton-type controlled-release preparations 4.2.1. Formulation process 4.2.2. Critical quality attributes 4.2.3. Supportive studies required 4.2.4. Special risks