Rules and Guidance for Pharmaceutical Manufacturers and Distributors 2022 (The Orange Guide)

The Rules and Guidance for Pharmaceutical Manufacturers and Distributors 2022 (11th edition), also known as The Orange Guide, is a reference book published by the Medicines and Healthcare products Regulatory Agency (MHRA). It contains European and UK guidance, legislation, and information related to the manufacture, importation, distribution, and brokering of human medicines and active substances.

This updated edition includes:

• Amendments from the Human Medicines Regulations 2012 on manufacturing, importation, assembly, wholesale dealing, and brokering.

• The Code of Practice for Qualified Persons and guidance on manufacture and importation.

• UK guidance on Good Distribution Practice (GDP) for wholesale distributors, brokers, manufacturers, importers, and distributors of active substances.

• Guidance on inspections, licensing conditions, broker registration, and controls on specific medicinal products.

• Updates on investigational medicinal products, including manufacturing authorisations, importation requirements, and pharmaceutical quality system expectations.

• Revised GMP Annexes 2 and 17, plus Commission guidance on good manufacturing practices for investigational medicinal products and active substances.

The book provides regulatory and practical information relevant to professionals involved in the pharmaceutical industry in the UK.

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