GUIDELINES ON PACKAGING FOR PHARMACEUTICAL PRODUCTS

Overview

This WHO guideline on packaging for pharmaceutical products outlines key aspects, including general considerations, information presentation, packaging materials, quality assurance, environmental factors, and quality specifications. It also addresses storage areas, labeling, self-inspection, quality audits, and international packaging standards, with specific requirements for containers for Japan, Europe, and the USA.

The document includes four appendices, providing guidance on:

Appendix 1: Storage areas

Appendix 2: Labels

Appendix 3: Self-inspection and quality audits

Appendix 4: International standards on packaging

Emphasizing safe and appropriate packaging choices, the guideline provides instructions on ensuring products reach as per required quality. Manufacturers must ensure packaging materials are compliant with requirements, do not introduce contaminants and maintain integrity throughout the supply chain.

Link to Documents

GUIDELINES ON PACKAGING FOR PHARMACEUTICAL PRODUCTS (WHO TRS 902 - ANNEX 9)