T/CNPPA 3015-2026 Active Group standards

T/CNPPA 3015-2026 On-site audit guide for suppliers of pharmaceutical rubber seals

Publish Date: 1970-01-01 Implement Date: 1970-01-01 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/CNPPA 3015-2026

Standard Type: Group standards

Standard Status: Active

is_force_gb: no

CCS Name: Fire fighting

ICS Name: Pharmaceutical Science

Publish Date: 1970-01-01

Implement Date: 1970-01-01

Scope

This guideline is applicable to on-site audits (hereinafter referred to as "audits") conducted by drug marketing authorization holders or entrusted third-party organizations on suppliers of rubber seals for drug packaging (hereinafter referred to as "rubber seals"). It is also applicable to the selection and evaluation of rubber seal suppliers before the drug is put on the market. This guideline elaborates in detail the process of supplier audits, as well as audit requirements, audit implementation, audit reports, improvement measures and effect verification, and the confirmation of qualified suppliers during the audit process.