Harmonisation achievements in the Quality area include pivotal milestones such as the conduct of stability studies, defining relevant thresholds for impurities testing and a more flexible approach to pharmaceutical quality based on Good Manufacturing Practice (GMP) risk management.

This document provides guidance on the good manufacturing practice for the manufacturing of active pharmaceutical ingredients (APIs) under an appropriate system for managing quality. It also aims to help ensure that APIs meet the requirements for quality and purity.

2023年11月1日 · Q7 Good Manufacturing Practice/GMP: Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients : Q7：原料药的药品生产质量管理规范指南: 阶段5: 2000.11.10: 有: Q7 Questions and Answers: Q7问答：原料药的药品生产质量管理规范指南问答: 阶段5: 2015.6.10: 有: 8: Q8 Pharmaceutical Development ...

This document is intended to provide guidance regarding good manufacturing practice (GMP) for the manufacturing of active pharmaceutical ingredients (APIs) under an appropriate system for

国家药品监督管理局药品审评中心ich办公室工作专栏相关信息

this guidance, but should be performed in accordance with GMP guidelines for drug (medicinal) products as defined by local authorities. This Guide covers APIs that are manufactured by chemical synthesis, extraction, cell culture/fermentation, by recovery from natural sources, or by any combination of these processes.

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is unique in bringing together the regulatory authorities and pharmaceutical industry to discuss scientific and technical aspects of …

本指南旨为在适当的质量管理体系下为活性药物成分（APIs）的生产提供关于药品生产质量管理规范 (GMP)方面的指导。 本指南也有助于确保APIs达到其预期的质量和纯度。 本指南中的“生产”一词被定义为包括APIs的物料接受、生产、包装、再包装、贴签，再贴签、质量控制、放行、贮存和分发等在内的所有操作，以及相关的控制。 本指南中的术语“应当”指期望使用的建议，除非不合适或可提供至少能得到同等程度的质量保证的另一种方法。 本指南中的“现行药品生产质量管理 …

本文件旨在为在合适的质量管理体系下制造活性药用成分（以下称原料药）提供GMP指南。 以确保原料药符合预期的或应当具有的质量特性与纯度要求。 本指南中所指的“制造”包括物料接收、生产、包装、重新包装、贴签、重新贴签、质量控制、放行、原料药的储存和销售及其相关控制的一系列活动。 本指南中，“应当”一词表示“只要遵循，肯定符合GMP”的各种建议。 也可以采用其他方法和手段，只要他们能满足实际情况的具体需求。 本指南中的“现行优良生产管理规 …

ICH简介：ICH原为International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use（人用药品注册技术要求国际协调会），现已更名为The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use（人用药品技术要求国际 ...