GMP Publications - Code of Federal Regulation Handbooks by the FDA

ICH Q7 with Q7 Auditors Check List

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1-933734-82-5

ICH Q7 is a worldwide harmonized GMP guideline for active pharmaceutical ingredients (chemical and biological), which covers all GMP aspects of manufacturing, quality control and trading. ICH Q7 - GMP for APIs This document was abstracted by the International Conference of Harmonisation (ICH).

Pharmaceutical manufacturers should know this guideline to make sure that their suppliers are in compliance with the necessary GMP rules. Includes the ICH Q7 Auditor's Checklist.

Table of contents:

  • Introduction
  • Quality Management
  • Personnel
  • Buildings and Facilities
  • Process Equipment
  • Documentation and Records
  • Materials Management
  • Production and In-Process Controls
  • Packaging and Identification Labelling of APIs and Intermediates
  • Storage and Distribution
  • Laboratory Controls
  • Rejection and Re-Use of Materials
  • Complaints and Recalls
  • Contract Manufacturers (including Laboratories)
  • Agents, Brokers, Traders, Distributors, Repackers and Relabellers
  • Specific Guidance for APIs Manufactured by Cell Culture/Fermantation
  • APIs for Use in Clinical Trials
  • Glossary
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