Introduction to Good Manufacturing Practices (GMP)

1. What is GMP?

Good Manufacturing Practices (GMP) provide guidance for controlling factors that affect product quality in food and pharmaceutical manufacturing. They cover facility design and construction, equipment and processing tools, supporting conditions, production preparation, processing, packaging, storage and the people responsible for these activities. GMP addresses the full manufacturing process and quality control.

2. Why establish and implement GMP?

GMP forms part of quality management and assurance. In pharmaceutical manufacturing, it helps prevent and reduce errors, mix-ups and contamination, protecting consumers from ineffective or potentially harmful products.

3. How does GMP help your organization?

GMP helps organizations to:

• Manage quality systematically and comprehensively;
• Reduce incidents and risks in production and business operations;
• Reduce costs and create opportunities to lower production costs;
• Build consumer confidence, competitiveness and production efficiency;
• Access relevant government or industry support where applicable.

4. Where is GMP applied?

GMP is a regulatory requirement for pharmaceutical manufacturing in many jurisdictions. The applicable requirements depend on the product category and destination market.

5. When is GMP useful?

• When pharmaceutical and cosmetic businesses seek access to international markets.
• When businesses seek consistent product quality, fitness for use, hygiene, safety and effective performance.

6. Who benefits?

Potential benefits include:

• For manufacturers: a quality-based management approach helps prevent or reduce contamination and errors in manufacturing, storage and distribution.
• For customers: GMP helps protect consumers from poor-quality or unsafe products.

WHO guidance on GMP