T/SHPPA 032-2025 Active Group standards

T/SHPPA 032-2025 Guidelines for establishing a integrated quality system pharmaceutical distribution

Publish Date: 2025-09-16 Implement Date: 2025-10-16 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

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Basic Information

Standard Code: T/SHPPA 032-2025

Standard Type: Group standards

Standard Status: Active

is_force_gb: no

CCS Name: \nRadioactive source

ICS Name: Comprehensive quality

Publish Date: 2025-09-16

Implement Date: 2025-10-16

Scope

This document sets forth the basic requirements for pharmaceutical enterprises to establish a unified quality system, clarifies management responsibilities and construction elements, which cover aspects such as organization and personnel, documents, training, information systems, risk control, vertical audits, supply chain master data, logistics standardization, drug traceability, after-sales services, and entrusted activities. This document is applicable to pharmaceutical enterprises in conducting centralized and large-scale unified quality system construction, as well as to their entrusted partners and drug marketing authorization holders (MAHs) engaged in joint construction of the unified quality system. The unified quality system construction of pharmaceutical retail chain enterprises' headquarters may be implemented as a reference. The unified quality system across the entire drug supply chain is an important means for enterprises to strengthen their quality management capabilities and risk prevention capabilities under new business models and new situations. It is also an important path to promote the large-scale development of enterprises and high-quality development of the industry, and to achieve regulatory coordination and mutual recognition. Establishing a unified quality system helps effectively implement the main responsibility for quality management of enterprises, form an effective self-supervision mechanism, achieve the goals of controllable quality risks, coordinated management efficiency, integrated regulatory compliance, and sustainable improvement, ensure the consistency of quality management implementation in affiliated enterprises, build a bridge for quality management systems among related enterprises, effectively assume the main responsibility for the entire life cycle of drugs, lay the foundation for establishing a cross-regional regulatory mutual recognition mechanism oriented towards a unified large market and meeting the needs of ce