T/ZJPA 002-2022 Active
T/ZJPA 002-2022 Energy-saving, Carbon-reducing and Emission-reduction Engineering Guide for Pharmaceutical and Chemical Enterprises
Abstract
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 process of research and development, technology transfer, and commercial production, analyzes the critical quality attributes (CQAs) that may affect the effectiveness and safety of the product, and elaborates on the inspection focus that differs from that of conventional preparations in terms of materials, equipment and facilities, production processes, and quality control.
General Product Information
| Document Type | Group standards |
|---|---|
| Standard Status | Active |
| Standard Code | T/ZJPA 002-2022 |
| Implement Date | 1970-01-01 |