Management Systems


ICH Q7, or the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients, is a guideline that provides recommendations for the manufacture of active pharmaceutical ingredients (APIs) under an appropriate quality management system. It is intended to help ensure that APIs meet the requirements for quality and purity that they purport or are represented to possess.

The Guideline Covers a Wide Range of Topics, Including:

  • Quality management system
  • Personnel
  • Premises and equipment
  • Production
  • Quality control
  • Documentation
  • Change control
  • Distribution

ICH Q7 is an important guideline for manufacturers of APIs, as it helps to ensure that their products are of high quality and meet the requirements of regulatory authorities around the world.

Key Principles:

  • Quality Management System (QMS) : Establish and maintain a comprehensive QMS that ensures the quality of APIs.
  • Documentation : Maintain detailed documentation of all manufacturing processes and procedures.
  • Personnel : Ensure that personnel are qualified and trained to perform their duties.
  • Premises and equipment : Design and maintain premises and equipment to prevent contamination and ensure product quality.
  • Materials : Control the quality of all materials used in API manufacturing.
  • Production : Operate production processes under controlled conditions.
  • Quality control : Conduct appropriate quality control testing to ensure product quality.
  • Records : Maintain complete and accurate records of all manufacturing activities.