Rules
and Guidance for Pharmaceutical Manufacturers Distributors 2015 - The Green
Guide
Author:
MHRA (Medicines and Healthcare products Regulatory Agency)
Publisher:
Pharmaceutical Press
Published:
2015
Hardback,
1 volume
Pages:
232 pp.
Product
Dimensions: 244 x 172mm
This is the ninth edition of
Rules and Guidance for Pharmaceutical Manufacturers and Distributors, compiled
by MHRA. Commonly known as the Green 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 Green Guide reproduces all the elements of the new Rules and
Guidance for Pharmaceutical Manufacturers and Distributors 2015 (the Orange
Guide) that are relevant to distributors. So if you’re involved in the
wholesale supply, distribution and brokering of medicines for human use and the
distribution of active substances, this is the one-stop guide you need.
This 2015 edition has been updated to incorporate the
revised EU Guidelines on Good Distribution Practice. In addition, it includes
new sections on:
§ GDP Quality Systems
§ The Gold Standard for Responsible Persons
§ MHRA Innovation Office
§ The Application and Inspection process – 'what to
expect'
§ List of persons who can be supplied with medicines by
way of wholesale dealing (Human Medicines Regulations 2012)
§ EU Commission Q&A on GDP guidelines
§ Controls on certain medicinal products
§ Compliance Management and Inspection Action Group
§ Handling returns of non-defective medicinal products
§ Risk-based inspection programme
§ Product recall/withdrawal – testing the recall process
§ Short term storage of ambient and refrigerated
medicinal products – requirements for a Wholesale Dealers Authorisation (WDA)
The work also
includes a new flow chart on registration requirements for UK companies
involved in the sourcing and supply of active substances (ASs) to be used in
the manufacture of licensed human medicines.
The Green Guide is
compiled by the Inspection, Enforcement and Standards Division, MHRA, London,
UK. Building on the restructured contents and fresh design of the last edition,
it’s easier than ever to find the answers you need.
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