Rules and Guidance for Pharmaceutical Manufacturers and Distributors 2015: The Orange Guide

Rules and Guidance for Pharmaceutical Manufacturers and Distributors 2015: The Orange GuideBook Reviews: Since the 2002 edition of Rules and Guidance for Pharmaceutical Manufacturers and Distributors (the “Orange Guide”) there have been many changes and additions to the detailed European Community guidelines on Good Manufacturing Practice (GMP). In addition, there is a new Directive dealing specifically with GMP and the Community code relating to medicinal products for human use (Council Directive 2001/83/EC) has itself been the subject of substantial revision, via amending Directive 2004/27/EC, and these changes have been transposed into UK domestic legislation.

GMP Directive:

The principles and guidelines of GMP are adopted by the European Commission under powers conferred by Council Directive 2001/83/EC. The objective 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 new requirements relating to the implementation of good manufacturing practice for medicinal products for human use (including Investigational Medicinal Products). The GMP Directive broadens the definition of good manufacturing practice set out in Directive 91/356/EEC and repealed the previous Directive in its entirety.

Changes to the Community Code:

The amendments made by Directive 2004/27/EC in relation to manufacturing, wholesale dealing, supervision and sanctions are contained in Articles 1(32) to (39) and (55) to (60), (77) and (78). These provisions were implemented in the United Kingdom (along with some other miscellaneous “tidying-up” changes) by making regulations amending the relevant provisions of the Medicines Act 1968. The new arrangements came into force on 30 October 2005. The headline changes are as follows:

  • New Community requirements1 on pharmaceutical companies to adhere to the principles of GMP in the manufacturing processes of active substances used as starting materials. This includes any repackaging or relabeling activities carried out by a distributor or broker.
  • New duty on QPs extending the need for full batch analysis and testing2 (or re-testing) in a Member State to product imported from third countries (i.e. outside the Community), whether or not the product was originally manufactured in the Community.
  • A new requirement3 for distributors that import medicinal products from other Member States to notify the marketing authorisation holder and the competent authority of the Member State to which the product is imported of the intention to import.
  • New powers4 for the competent authority to carry out unannounced inspections at the premises of manufacturers of starting materials, or at the premises of marketing authorisation holders or any firms employed by the marketing authorisation holder where there are grounds for suspecting non-compliance with GMP principles.
  • Changes to the system of licensing for third country imports. The importation of products from third countries now requires a manufacturing authorisation for import, rather than, as previously, a wholesale dealer’s import licence.

Bibliographical Data of Rules and Guidance for Pharmaceutical Manufacturers and Distributors 2015: The Orange Guide 1st Ed

Reference Type: Book
Record Number: XX
Author: Enforcement and Standards Division of MHRA Inspection
Year: 2015
Place Published: London, UK
Publisher: Pharmaceutical Pr
Number of Pages: 648
Edition: 1
ISBN -10: 085711171X
ISBN-13: 978-0857111715
Buy: Get it on Amazon

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