GOOD MANUFACTURING PRACTICES FOR EXCIPIENTS USED IN PHARMACEUTICAL PRODUCTS

Overview

The linked document, WHO Technical Report Series No. 1052, Annex 2: Good Manufacturing Practices for Excipients Used in Pharmaceutical Products, offers detailed guidance on the principles and practices necessary to ensure the quality, safety, and consistency of pharmaceutical excipients. It outlines key aspects such as manufacturing processes, quality control, risk management, and regulatory expectations for excipients, which are critical components of pharmaceutical products.

To ensure full compliance and a robust understanding of these requirements, it is crucial to carefully review the entire document. Applying specific sections or recommendations in isolation may lead to gaps in implementation, potentially impacting product quality and safety. This document serves as an important resource for manufacturers, regulators, and other stakeholders involved in pharmaceutical production.

Link to Document

TRS 1052 - ANNEX 2: WHO GOOD MANUFACTURING PRACTICES FOR EXCIPIENTS USED IN PHARMACEUTICAL PRODUCTS