The Rules and Guidance for Pharmaceutical Manufacturers and Distributors 2022 (11th Edition), commonly known as The Orange Guide, is an essential reference published by the MHRA, covering UK and European regulations for the manufacture, importation, and distribution of medicines and active substances.
This edition includes key updates to the Human Medicines Regulations 2012, expanded guidance on Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP), and the Code of Practice for Qualified Persons. It also covers licensing, inspections, broker registration, and controls on specific medicinal products.
Additional updates address investigational medicinal products, pharmaceutical quality systems, and revised GMP annexes, reflecting current regulatory standards in the UK.
Designed for professionals in the pharmaceutical industry, this guide provides reliable and up-to-date regulatory and practical insights.