T/ZJPA 001-2022
Site inspection guide for oral sustained/controlled release preparations (English Version)

Standard No.

T/ZJPA 001-2022

Language

Chinese, Available in English version

Release Date

2023

Published By

Group Standards of the People's Republic of China

Latest

T/ZJPA 001-2022

Scope

4 Overview of Oral Sustained and Controlled Release Preparations 4.1 Film-coated Sustained and Controlled Release Preparations 4.1.1 Prescription Process 4.1.2 Critical Quality Attributes 4.1.3 Required Supporting Studies 4.1.4 Special Risks 4.2 Matrix Sustained and Controlled Release Preparations 4.2. 1Formulation process 4.2.2 Critical quality attributes 4.2.3 Supporting studies required 4.2.4 Special risks

T/ZJPA 001-2022 history

• 2023 T/ZJPA 001-2022 Site inspection guide for oral sustained/controlled release preparations
• 2021 T/ZJPA 001-2021 Technical consideration of environmental microbial database construction in pharmaceutical industry