Rules and Guidance for Pharmaceutical Manufacturers and Distributors 2017

The Orange Guide

Author:

Medicines and Healthcare Products Regulatory Agency (MHRA)

Publisher:

Pharmaceutical Press

This is the tenth edition of Rules and Guidance for Pharmaceutical Manufacturers and Distributors, compiled by MHRA. Commonly known as the Orange Guide, it remains an essential reference for all manufacturers and distributors of medicines in Europe. It provides a single authoritative source of European and UK guidance, information and legislation relating to the manufacture and distribution of human medicines.

The new 2017 edition has been updated to incorporate changes and additions made to the detailed European Community guidelines on Good Manufacturing Practice (GMP) and the revised EU Guidelines on Good Distribution Practice (GDP), including Annexes 15 and 16.

Key features

New content includes:

• Qualification of suppliers and customers

• Parallel importation and parallel distribution

• Temperature control and monitoring

• UK legislation

• Unlicensed medicines

• GMP for excipients

• Guidance on revised Annex 16 of GMP

• Data Integrity definitions and guidance for industry

• Principles and guidelines of GMP for active substances

• Principles of GDP of active substances

• Setting health based exposure limits

• Formalised risk assessment for ascertaining the appropriate GMP for excipients

Extent	806 pages	ISBN	9780857112859
Size	244 x 172mm	Price	£80.00
Format	Paperback	Published	06 Jan 2017
Availability	Out of stock - available to order	Delivery	Delivery options and charges