(GMP) for the manufacturing of active pharmaceutical ingredients (APIs) under an appropriate system for managing quality. It is also intended to help ensure that APIs meet the requirements

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.

“api起始物料”是一种原材料、中间体或在生产某一个api时，作为该api一个重要结构片断被引入终产物结构中的另一个api。一种“api起始物料”可以是一种商品，也可以是一种根据合同或商业协议从一个或多个供应商中购买的物质，或者是企业自己生产的物质。

2014年1月22日 · 药物活性成分(api)cgmp：质量体系管理方式 星级： 5 页 （活性成分）和药品（制剂） GMP - API

In this FDA inspection webinar attendees will learn the basic understanding of Active Pharmaceutical Ingredient Good Manufacturing Practices (ICH Q7) and the most important elements of API GMP to avoid serious deviations and failures during either a Pre-Approval or GMP Inspection.

2024年10月2日 · 原料药API（Active Pharmaceutical Ingredient）的GMP（Good Manufacturing Practice）认证，是保证药品质量和安全的关键步骤。 GMP认证的核心包括：文件系统、生产设备、人员培训、环境控制、质量管理。 在这些核心中， 质量管理 尤为重要，它确保每一批产品都符合标准，避免任何潜在风险。 在质量管理中，首先需要建立一个完善的质量保证体系。 这个体系应包括质量目标、质量保证计划、质量控制程序和质量审核等多个方面。 质量目标应明确、 …

implement appropriate GMPs at all stages of the API supply chain, including distribution. A table is provided as an Annex of this document showing the link between each Q&A and the relevant sections

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。

Explore the crucial role of regulatory compliance in API manufacturing. Learn about key standards like GMP, WHO guidelines, and regional regulations (FDA, EU GMP, ICH). Discover how Bio-Synth's commitment to exceeding these standards ensures the safety and quality of its APIs and contributes to a safer healthcare system.

The ICH Q7 guideline provides details of Good Manufacturing Practice (GMP) for Active Pharmaceutical Ingredients (API). It is a guideline adopted globally for applying GMP to APIs (drug substances) and is crucial to ensure consistent quality and safety throughout the API manufacturing process.