DZ/T 0101.12-1994
Active
T/ZJPA 002-2022
Active
Group standards
T/ZJPA 002-2022 Energy-saving, Carbon-reducing and Emission-reduction Engineering Guide for Pharmaceutical and Chemical Enterprises
T/ZJPA 002-2022 Energy-saving, Carbon-reducing and Emission-reduction Engineering Guide for Pharmaceutical and Chemical Enterprises
Price:
$ 43.00
Basic Information
Standard Code:
T/ZJPA 002-2022
Standard Type:
Group standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
-
ICS Name:
-
Publish Date:
1970-01-01
Implement Date:
1970-01-01
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 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.
Development Information
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