“ISPE is the international society of choice for technical
professionals in the regulated health care manufacturing industries.
We are the leading world-wide provider of forums and educational
services to promote the development and sharing of technical
knowledge and practical experience to benefit our members.”
Chairman’s Report by Bob Adamson
N
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Issue
No. 52
Spring
2010
On completion of my first
year as UK Affiliate Chair I
can reflect back and look at
our achievements over the
past year. There is no doubt
that times for our industry are
extremely difficult. Recent
announcements
of
reductions in two of our
major companies have left a
lasting impression on the
state of our industry. The UK
Chair’s role has been both an
interesting and challenging
experience
and
quite
different from most of my
more recent roles at the
international level.
Organising and running an
affiliate of UK’s size in the
current climate is not easy
with pressure on all our
volunteers especially in
respect of travel and “prime
work” time. However, our
society remains strong.
Numbers have reduced
locally and internationally
with a UK membership of just
under 1,000.
We have seen the effect on
our Scottish Region and we
have had to take the only
decision possible and windup this regional group in spite
of the sterling efforts of the
Region’s Chair and his
committee. The UK affiliate
would particularly like to
thank Hamish McArthur for
all his hard work.
Our other regional affiliates
remain
strong
with
committed
and
active
members serving on the
regional committees. These
dedicated volunteers are the
"life blood” of our society and
we owe them due thanks and
recognition for this service.
A number of regional chairs
stand down this year, Steve
Riley, Brian Ravenscroft,
Michel Edwards and we
welcome Lynn Bryan, Steve
Boswell and Alan Halstead to
our affiliate committee.
We have continued with a
number of initiatives and now
have 3 active Communities
of Practice. The UK has
opted
to
give
these
substantial supports both in
encouragement
and
financially. Our aim is to
continue to focus on
providing member benefit
and so encourage greater
involvement in the society
Our connection with the
European Affiliate Council
and Education in Europe
remains strong although we
have seen the number of
European seminars diminish
from 4 to 2. Our increased
co-operation with other UK
Institutions is improving and
working well (I.ChemE,
IMechE). This will continue
through 2010/11.
We face a difficult and
challenging period for the
industry in the UK and we
need to continually review
and challenge our own
programmes and initiatives
so that we are focussed on
delivering benefit to our
members who are our key
resource and customer.
COP UPDATE
SUSTAINABLE FACILITIES
The sustainable facilities COP is an active
community holding regular meetings and
working in teams to generate guides for
best practice, technology and Legislation
and Regulation. The CoP is keen to hear
from manufacturers with case studies that
can be shared and used to help in setting
up these guides.
For more information and contact details,
please see the back page advertisement.
The GAMP UK CoP
inaugural meeting took
place at Pall Life sciences
on 29th April 2010. The
meeting was well attended
and successfully “kick
started” the CoP activity
The GAMP CoP and
Southern
Regional
Committee are organising
a 1 day seminar “GAMP –
Meeting the Challenges of
Regulatory Evolution” in
Bracknell on 16th June
2010.
Full details are available
on the ISPE website and a
limited number of table top
exhibition spaces will be
available.
ISPE INFO UPDATE - NEW REGIONAL CHAIRS
SOUTHERN REGION
Alan Halstead
Alan Halstead has taken over
from Michel Edwards as
Southern
Regional
Chairman.
Alan is an electro-mechanical
engineer working for PM
Project Services.
He has been involved in the
pharmaceutical industry for
12 years providing technical,
validation and compliance
expertise for Pharmaceutical
and Biotech facilities.
Alan also spent a number of
years
in
Weapons
Engineering.
Co-author of “Calibration
Management” his recent
focus has been on applying
Risk MAPP as the guidance
is due out in the very near
future
Alan was Chair of the ISPE
UK & Ireland Community of
Practice
for
Process
Analytical
Technology
between 2005 and 2009, and
will continue to take an active
interest in the PAT CoP.
Alan says, “the Southern
Region Committee’s main
focus this year will be the coordination of the 2010 Annual
event and looking to enhance
the service to the region’s
membership by making use
of the specialist technical
information from the CoPs
and the diverse range of
ISPE training packs.
This should enable us to
provide a much needed
review of the technical
advances
against
the
revisions of the regulatory
and baseline guides for next
year.”
CENTRAL REGION
Steve Boswell
Steve Boswell has been
elected
Central
Region
Chairman to succeed Brian
Ravenscroft and has been
involved with supporting the
ISPE central region committee
for many years.
Steve has worked in the
pharma
and
healthcare
industry for over 20 years,
specialising in solid dosage
form
processes
and
containment systems, working
for Glatt and GEA Pharma
Systems.
Steve said, “I have had the
pleasure of working on many
international projects and sites
worldwide, it is a great industry
with many talented people,
although, going through a
significant change the ISPE
has an important part to play in
that change”
Steve has recently started his
own
process
equipment
business, S3 Process and
Packaging Equipment Ltd,
representing manufacturers
such a Gerteis, GEA Courtoy
and Buck Valves, Krieger and
GF amongst others.
Steve commented, “I would
like our region to focus on
communicating
process
innovation and encouraging
the use of new technologies to
help improve our product
development
and
m a n u f a c t u r i n g
competitiveness in the UK. We
have a very experience central
committee team with a wide
range of skills we will be
organising an interesting
range of seminars for 2010.
We will also look to encourage
new members and help
communicate the benefits of
ISPE membership”
Pharmaceutical Manufacturing Engineer - Europe
Zogenix is a specialty pharmaceutical company whose goal is to uniquely enhance and differentiate
medicines by incorporating innovative technologies in an effort to relieve suffering in people with CNS and
pain disorders
Zogenix is currently seeking an experienced, highly motivated Pharmaceutical Manufacturing Engineer to play a key role in ensuring
commercial manufacturing processes and equipment located in Europe consistently deliver DosePro product to the market according
to the approved production plan, quality requirements, and cost targets. This position will report to the Director of European
Operations, and is located in the U.K.
The successful candidate will have:
Qualified to Degree level in Engineering (Mechanical, Chemical, Electrical Engineering strongly preferred)
Minimum of 8-10 years experience with processes in a production environment, at least 5 in a aseptic pharmaceutical environment.
Significant experience working with third party vendors and contract manufacturers in a role requiring relationship building.
The candidate must have experience with validation of automated equipment, and familiarity with cGMP/Regulatory aspects of aseptic filling
processes.
Ability to travel up to 25-50% of time
If you desire to make a difference and are looking for a unique and challenging career opportunity please send your resume to: hr@zogenix.com
Be a part of an emerging industry leader with Zogenix!
NOTES FROM THE EDITOR - JON YOULES
There have been a lot of changes to the
organising committees since the previous
newsletter and each Regional Chair will
be looking to organise events to support
the industry in the face of significant
changes within manufacturing.
The ISPE needs the active participation of
the Membership to ensure the UK industry
continues and thrives and we would
encourage you to take part by attending or
contributing to the local events.
Any company interested in supporting the
UK Affiliate whilst reaching the readership
of the ISPE UK Newsletter is invited to
contact me about advertising within this
Newsletter
My contact details are - Tel: 01494 792898 - Mobile: 07711 633105 - Email: jony@ytron-quadro.co.uk
ISPE INFO UPDATE - NEW NORTHWEST REGIONAL CHAIR
Lynn Bryan
Lynn Bryan of Ballygan
consulting has recently been
appointed Chair of the North
West region, taking over from
Steve Riley.
Lynn is currently working on
QP
release
of
sterile
radiopharmaceuticals and has
a broad range of experience
within the pharmaceutical
industry
working
in
manufacturing and as a
consultant.
Lynn has worked making
blood products and vaccines,
sterile products, freeze dried
products, tablets, capsules
and aerosols (MDI’s, DPI’s,
pump sprays).
Prior to this Lynn was the
director of an independent
validation company and has
also worked for Welcome and
Fisons in both production and
QA roles.
Lynn been actively involved
with the ISPE Northwest
Committee for 10 years and
worked on the UK affiliate as
ISPE European Education
Liaison for 2 years. During this
time she has been involved in
presenting training courses on
validation, training approach,
GMP
and
systems.
water/steam
One of Lynn’s key goals is to
meet the needs of the
membership and Lynn says
she is “looking forward to
working with the North West
Committee to develop a strong
programme of events in the
coming
year
providing
interesting and informative
evening seminars and visits to
ensure members feel they
receive value for money from
their ISPE membership”
DIARY OF EVENTS 2010
The provisional plans are currently
under development. More details are
available on the ISPE website
Central Region
Chair - Steve Boswell
Tel: 07891 485368
Email: sboswell@s3process.com
Jun 2010: Sustainability Seminar
Location: Siemens Turbines, Lincoln
Sep 2010: Containment Seminar
Location: TBC
Oct 2010: Continuous Processing
Seminar. Location: TBC
North East Region
Chair - Bruce Williams
Tel: 07944 766 508
Email: bruce@williamsprocess.co.uk
Jun 2010: Sustainability
Afternoon half day seminar.
Location: Newcastle University
Sep 2010: Biotech Seminar
Evening seminar and networking
opportunity in partnership with NEPIC Location: Bracknell
Details to be confirmed
20 Oct 2010: Process and Utility
Steam.
Q4 2010: GAMP seminar
Seminar and demonstration
Details to be confirmed
Location: Spirax Sarco
North West Region
18 Nov 2010 – SUSTAINABILITY –
Chair - Lynn Bryan
Applications of the Principles in
Tel: 07970 004620
the Pharmaceutical Industry
Awards Dinner and Conference
Email: lynn@ballygan.com
Location: Heathrow
7 Jul 2010: Forum Evening
Details tbc
Q4 2010 – BRITEST
Location: TBC
22nd Sep 2010: Innovations in
Water and Steam. Details tbc
Nov 2010: Packaging seminar
PPMA EVENTS & NEWS
Details tbc
Southern Region
Chair - Alan Halstead
Tel: 07879 432 587
Email: Alan.Halstead@pmg.co.uk
16 Jun 2010: GAMP – Meeting the
Challenges of Regulatory
Evolution
Seminar and practical demonstration
TOTAL
Processing and Packaging 2010
at the NEC
25th - 27 May 2010
PPMA Ltd.
Tel: 020 8773 8111
www.ppma.co.uk
SUSTAINABILITY
Application of the Principles in the Pharmaceutical Industry
S
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What is Sustainability?
It seems that there are wide-ranging views
on the definition of sustainability but to quote
Wikipedia it is: the ability to endure...The
most
widely
quoted
definition
of
sustainability and sustainable development,
is that of the Brundtland Commission of the
United Nation on March 20, 1987:
“sustainable development is development
that meets the needs of the present without
compromising the ability of future
generations to meet their own needs.”
The 2010 Annual Awards Conference will
look at how the Pharmaceutical industry is
currently meeting the challenges of
Sustainability and how we can adopt
principles of Sustainability in both Facilities
and Processes in the future.
With leading speakers from Manufacturing
and Engineering groups presenting papers
on the latest developments and how the
most up to date facilities have performed,
delegates to the conference will learn the
latest Sustainability developments in our
industry sector and have opportunity to
interact with the speakers and other
delegates as well as the conference
Exhibitors.
The conference will also have input from
outside the industry where innovative
approaches in projects such as 2012
Stratford City Regeneration Project and the
Salford
Quays
Regeneration Project
'Media City' may provide new ideas for
Sustainable
construction
in
the
pharmaceutical sector.
Agenda
08:00
09:00
Registration / Coffee / Exhibition
Welcome introduction
Conference Chair: Bruce Davis, Principal Consultant, Global Consulting
Southern Regional Cairman: Alan Halstead
09:20
Keynote Address
09:55
Leadership in Sustainability: insight from a construction company perspective
Richard Parmenter, Vice President GMS Head of Engineering and EHS, GSK
Dr Paul Toyne, Head of Sustainability, Bovis Lend Lease and London Sustainable
Development Commissioner.
10:30
10:40
11:00
Sustainable Facilities CoP update
Coffee break and exhibition
ISPE Facility of the Year for Sustainability: Centocor Biologics Ireland update
one year on
11:35
Sustainable Design for Complex Facilities
12:05
Sustainability – The European Perspective
12:35
13:50
Lunch and Exhibition
Sustainable Pharmaceutical Manufacturing
14:20
Pfizer approach to Green Manufacturing
14:50
15:10
Coffee break and exhibition
Process and Sustainability
15:40
Genzyme Sustainable Green Chemistry
16:10
Summary and Q&A session
Conference close at 16:30
Con Leddy, PM Group Associate Director, Group Sustainable Energy Engineering
Speaker to be confirmed
Mike Murray, Technical Affairs Manager, ABPI
Speaker to be confirmed
Speaker to be confirmed
Speaker to be confirmed
Dr Peter McDonnell, Technical Director, Genzyme
The Agenda is still under development and timings and topics may be subject to revision.
SUSTAINABILITY
Application of the Principles in the Pharmaceutical Industry
S
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The Annual Awards Conference, Exhibition and Dinner 18th November 2010
The Annual Awards Conference, Exhibition and Awards Dinner will take place at the Park Inn
Hotel, Heathrow, London on the 18th November 2010 and will be organised by the Southern
regional committee under its Chairman Alan Halstead.
The title of the Conference is:
"Sustainability - Application of the Principles in the Pharmaceutical Industry"
Plans for the event are well underway and Booking for the Conference and Dinner can be made now.
A booking form for the conference is included in this newsletter.
Sponsors for the event are:
Bovis Lend Lease
Faithful & Gould
C21C
MRC Systems
Cyril Sweett
Matini Group
Energy and Carbon Reduction Solutions
PM Projects
We would be pleased to hear from any company who would like to become a sponsor of the event.
There are still a small number of table top Exhibition spaces available and these can be booked with
The Event Bookers or a reservation form can be downloaded via the ISPE website www.ispe.org/uk
For any booking details or any queries regarding the event, please contact: The Event Bookers Ltd, 6 Gorse Close, Locks Heath, Southampton. SO31 6XZ.
Telephone 01489 571213. Fax. 01489 854599. E-mail. ispe@bookerevents.co.uk
Don’t forget to visit the website - www.ispe.org/uk