
Rules and Guidance for Pharmaceutical Manufacturers and Distributors UK Edition PDF Free Download
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 investi...