Академический Документы
Профессиональный Документы
Культура Документы
• Impact test/s vehicle will of course result in another Guide to Good Distribution Practice of Medicinal
• Vehicle description mapping test being undertaken, but Products for Human Use
https://www.hpra.ie/docs/default-source/
• Monitor type better a new test than have temperature publications-forms/guidance-documents/
• Mapping type (temperature/ issues when shipments of actual product ia-g0046-guide-to-good-distribution-practice-
humidity) are loaded inside the vehicle. It’s also of-medicinal-products-for-human-use-v2.
• Data logger specification important to implement ‘load limit’ lines pdf?Status=Master&sfvrsn=6
• Data logger configuration to avoid the vehicle being overloaded,
• Data logger calibration (3pt which can result in poor airflow and out-
traceable to national or international of-specification readings in some areas.
standards)
• Mapping report content Ultimately things are changing, and
overview more and more mapping is taking
• Deliverables place throughout the transport industry.
• Floor plans/diagram It is in everyone’s interest to hope that
this upward trend continues, ensuring
Reviewing the Data regulatory compliance and that vehicles
Once the mapping exercises have been are suitable for use, but ultimately Andy Hughes started his
completed and the reports issued with ensuring we are doing our part in getting logistics career in 1992,
their findings and any recommendations, drugs to the patient in the best possible with a multi-national
the next critical step is to review the data condition. freight forwarder. He
with your quality team. The data actually moved on to work for the
helps to give you a better understanding References
UK’s freight association,
European Commission
of how your vehicles perform in certain Guidelines of 5 November 2013 on Good BIFA, as its head of
conditions and situations, allowing you Distribution Practice of Medicinal Products for communications,
to make good decisions based on actual Human Use lobbying Government
data gathered during these tests. As http://eur-lex.europa.eu/LexUriServ/LexUriServ. on transport issues. In 2003 he helped
mentioned in the vehicle test summary do?uri=OJ:C:2013:343:0001:0014:EN:PDF establish Pharmafreight, a freight
here, one of the key parts in a good company handling only pharmaceuticals
The ECA (European Compliance Academy) & the
mapping exercise is to conduct an PQG (Pharmaceutical Quality Group) and related products, under good
impact test. The data illustrates how long Draft Chapters on GDP Interpretation of the EU distribution practice (GDP). Andy travels
the cargo compartment(s) being used GDP Guidelines – Section 9 Transportation extensively, setting up GDP operations at
will hold the correct temperature range http://www.pqg.org/shop/guidelines/43-eca- partners around the world, and offers
pqg-gdp-guideline-chapter-9-good-distribution-
required. Then put that data into a real- advice to key industry organisations.
practice.html
life situation, whether that is a vehicle http://www.good-distribution-practice-group. Email: andy.hughes@pharmafreight.com
breakdown, or there are no open-deck org/gdp_news_3973_7940,S-GDP.html
positions available on a cross-Channel h t t p : / / w w w. g m p - c o m p l i a n c e . o r g /
ferry, so leaving the engine running on the enews_03973_.html
Kane Edgeworth,
vehicle is not an option. The impact test
WHO (World Health Organization) Managing Director,
data gives you specific information about Annex 9 - Model guidance for the storage and Biomap Ltd. Kane has
what will happen to the temperatures transport of time and temperature sensitive worked in cold chain
on the vehicle, allowing the transport pharmaceutical products
compliance since 1999
operator – along with its client – to make Section 6.6 Qualification of temperature-
controlled road vehicles and launched Biomap
informed decisions about what action to
http://apps.who.int/prequal/info_general/ Ltd in 2008, specialising
take.
documents/TRS961/TRS961_Annex9.pdf in temperature
qualification services. Kane works across
Recommendations MHRA 2014 Orange Guide
the pharmaceutical industry with clients
The data will also highlight any unusual Rules and Guidance for Pharmaceutical
Manufacturers and Distributors 2014 – the throughout the UK and the Middle East,
hot or cold spots within a vehicle, giving
‘Orange Guide’ regularly presents at GDP workshops
you the appropriate information to be
h t t p : / / w w w. m h r a . g o v. u k / P u b l i c a t i o n s / and is also a member of the GDP working
able to make decisions about where not Regulatoryguidance/Medicines/ group driven by the ECA and PQG for
to load product in a vehicle, or to make Othermedicinesregulatoryguidance/ interpretation of the 2013 EU GDP
some changes to a vehicle’s configuration CON2030291
guidelines.
or layout. Any structural changes to a
HPRA (Health Products Regulatory Authority) Email: kane.edgeworth@biomap.co.uk