This document aims to assist in the establishment of a single set of global specifications for new drug substances and new drug products. It provides guidance on the setting and justification of acceptance criteria and the selection of test procedures for new drug substances of synthetic chemical origin, and new drug products produced from them.

The guideline continues to provide a general framework for the principles of analytical procedure validation applicable to products mostly in the scope of Q6A and Q6B. These guidelines (Q2(R2) and Q14) are intended to complement ICH Q8 to Q12 Guidelines, as well as ICH Q13 for Continuous Manufacturing.

2023年11月1日 · Q6A: Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances Q6A：质量标准：新原料药和新药制剂的检测方法和可接受标准：化学药物

2023年11月1日 · ICH指导原则由国家药品监督管理局药品审评中心发布，提供药品研发和审评的指导。

ich指导原则质量标准：“生物/生物技术制品的检测验方法和认可限度”阐述了对生物/生物技术制品的标准、检测项目和方法。 本指导原则不涵盖放射药物、发酵制品、寡聚核苷酸、草药和来源于动植物的粗制品。

It provides guidance on the setting and justification of acceptance criteria and the selection of test procedures for new drug substances of synthetic chemical origin, and new drug products produced from them, which have not been registered previously in the United States, the European Union, or Japan.

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Establishment of a single set of global specifications for new drug substances and products. Guidance on the setting and justification of acceptance criteria and the selection of test procedures.

Acceptance criterion = qualified level or establish new qualified level3 or new storage conditions or reduce shelf life. 1 Relevant batches are those from development, pilot and scale-up studies. 3 Refer to ICH Guideline on Impurities in New Drug Products. Is the drug product a solid NO dosage form or liquid containing undissolved drug substance?

Q6A：质量标准：新原料药和新药制剂的检测方法和可接受标准：化学药物. 本指导原则旨在尽可能建立起一套全球性的新原料药和新药 制剂的质量标准。 它为化学合成的新原料药及其制剂检测方法的 选择、可接受标准的制订和论证提供了指导， 这些新药尚未在美 国、欧盟、日本注册。 质量标准由一系列的检测项目、相应的分析方法和合理的可 接受标准组成，可接受标准以限度值、范围或其他描述来表示。 质量标准建立了一套原料药或制剂都必需遵循的、与其用途相适 应的 …