Good Distribution Practice
Scope
This intensive one day course is intended to evaluate Good
Distribution Practice (GDP) as required by Directive
2001/83/EC, Directive 2004/27/EC, EU Guidelines on Good
Distribution of Medicinal Products for Human Use 2013/C
343/01 and the new requirements included in the MHRA
Orange/Green Guides. It offers a practical explanation of
the guidelines for those who are active in the field of
setting up and implementing GDP, as well as those
involved in the management of quality systems for
pharmaceutical products.
It reviews GMP/GDP supply chain integrity and examines
the risk of counterfeit pharmaceutical products, a growing
concern today. The course also reviews examples of
deficiencies found by regulators and how to improve
compliance in these critical areas.
Suitability
The course is aimed at any company that has, or is,
considering obtaining an MHRA/EU Wholesale Distribution
Authorisation, wholesalers/distributors, manufacturers,
pharmaceutical suppliers, brokers, service/transport
providers and partners who carry out any GDP activities on
behalf of licence holders.
Responsible Persons (RP’s), deputy RP’s, quality managers,
auditors, and regulatory/compliance personnel will all
benefit from this course.
Tel: +44 (0)118 918 4076 E-mail: enquiries@rssl.com Bookings: bookings@rssl.com Web: www.rssl.com
RSSL Training
Reading Enterprise Centre, Earley Gate, Whiteknights Road, Reading, Berkshire, RG6 6BU
Additionally it is also recommended for those in logistics,
supply chain, warehousing, transport and distribution,
customer services and purchasing.
It may be modified to run in-house within client
companies.
Learning Outcomes
The course is a highly interactive ‘hands on’ learning
experience, by the end of which you will:
• Understand what GDP is and why is it so essential
for patient safety
• Be familiar with GDP as covered by EU Directives/
Regulations and Guidelines (including the
Orange and Green Guides)
• Understand the MHRA perspective on the guidelines,
and their expectations with regard to GDP in practice
• Have an insight in to current MHRA ‘Hot Topics’ in GDP
• Appreciate the dangers and challenges posed by
counterfeit products
• Understand your GDP responsibility from product
sourcing through to final customer delivery