This publication serves as a comprehensive reference for European and UK guidance and legislation concerning the manufacture and distribution of medicines for human use. The Orange Guide, compiled by the Inspection and Standards Division of the Medicines and Healthcare products Regulatory Agency, consolidates essential information for professionals in this field. It emphasizes the critical necessity of adhering to Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) in the production and supply chain of pharmaceuticals. This edition specifically incorporates significant updates to EU GMP guidelines, revisions to EU directives on medicinal products, and the introduction of new directives on GMP principles.

The Orange Guide has historically been an essential reference for professionals involved in the manufacture or distribution of medicines within Europe. Its authoritative compilation of European and UK guidance documents and legislation makes it a critical resource for ensuring compliance with Good Manufacturing Practice and Good Distribution Practice. This edition's updates reflect significant changes in EU directives and GMP guidelines, underscoring its role as a vital, current reference for the pharmaceutical industry.