The book Rules and Guidance for Pharmaceutical Manufacturers and Distributors is written by the Medicines and Healthcare Products Regulatory Agency. GMP principles and guidelines are adopted by the European Commission under the powers conferred by Council Directive 2001/83/EC. This is to ensure that all medicinal products for human use manufactured or imported into the Community, including medicinal products intended for export, are manufactured in accordance with GMP principles and guidelines.
The goal of GMP is to ensure that products are consistently produced and controlled to particular quality standards. Commission Directive 2003/94/EC (the “GMP Directive”) sets out the requirements related to the implementation of GMP for medicinal products for human use (currently including investigational medicinal products (IMPs)).
• parallel importation and parallel distribution;
• temperature control and monitoring;
• UK legislation; and
• matters relating to unlicensed medicines.
There are also new MHRA sections on:
• GMP for Excipients;
Topics of this Edition
Guidance on Good Manufacturing Practice (GMP)
Guidance on Manufacture and Importation
Legislation on Manufacture and Importation
Guidance on Good Distribution Practice for Wholesaling, Brokering and Active Substances
Legislation on Wholesale Distribution and Brokering Medicines
Overview of Rules and Guidance for Pharmaceutical Manufacturers and Distributors
Familiarly known as the Orange Guide, this title is an essential reference work for all those involved in the manufacture and distribution of medicines in Europe. It is compiled by the UK medicines regulator, MHRA, and brings together UK and European guidance documents and information on legislation relating to the manufacture and distribution of medicines for human use. Contains EU guidance on good manufacturing and distribution practice along with relevant information on EU and UK legislation.
|Book Name||Rules and Guidance for Pharmaceutical Manufacturers and Distributors|
|Author of Book||Medicines and Healthcare Products Regulatory Agency|