SeerPharma Journal
April 2015
Welcome to the
first edition of the
SeerPharma Journal!
It’s been an exciting start to 2015 as we continue to work
on an initiative to meet with you to understand your current
concerns from quality and GMP perspectives. We appreciate
the time that you set aside for us, and we look forward to
meeting more of you soon. The Journal represents the first
of many publications that will look to share the latest insights
and feedback from you – our valued customer.
Our Training division has been quite busy delivering courses
on-site for many of our clients on a variety of topics ranging
from Internal Audits for a major pharmaceutical manufacturer,
to Compliance and Risk Assessment for a group involved with
Cellular Therapies. We’ve also had a number of people attend
our publicly scheduled course on “Introduction to GMP”.
It’s clear many of you are interested in tapping into our
expertise to deliver workshop style training sessions, where
our consultants can work with your team to upskill and
assist with making yourselves more operationally efficient.
As opposed to just being a “Consultant” or a “Trainer”, you
benefit from us being a hybrid of the two.
SeerPharma’s software team have also had a demanding
and exciting start to the new year, with a number of major
government and publicly listed organisations contacting us for
assistance with validating their LIS/LIMS platforms. Through
our engagement we’ve come to realise that you see us as a
middle person between the Science and the IT department/
supplier, and we’re proud to play that role.
In this issue, we’ll share with you some of the areas of expertise
that you’ve asked us to deliver on, plus a publication from the
University of Technology, Sydney about our recently launched
postgraduate programs for Good Manufacturing Practice.
I hope you enjoy the issue!
2 | SeerPharma Journal | April 2015
www.seerpharma.com
Health World Ltd look to SeerPharma to
provide training on site for introduction to GMP
and behavioural GMP
4
Australian medical device manufacturer
approaches SeerPharma for their expertise on
computer system validation
5
Global pharmaceutical company approaches
SeerPharma to perform audits
6
Multinational
pharmaceutical
company
commits to further online GMP training from
SeerPharma
7
Leading Australian natural health brand
implements SeerPharma GMP e-learning
7
GMP training
pathways
career
8
Our perspective on manufacturing in the
pharmaceutical and medical device industry
9
www.seerpharma.com
provides
excellent
SeerPharma Journal | April 2015 | 3
Health World Ltd look to SeerPharma to
provide training on site for introduction
to GMP and behavioural GMP
Health World Limited has grown to become a market leader and one of the most trusted suppliers
of Natural Medicines in Australia and New Zealand. Much of Health World Limited’s success is
due to its strict adherence to its mission of helping people live happier, healthier lives.
Since the company’s formation over 20 years ago, Health World Limited’s quality processes have
continued to set new standards in safety and efficacy, and will continue to do so into the future.
Health World Limited is Australia’s and New Zealand’s leading natural health science company,
helping people live happier, healthier lives.
Health World Limited approached SeerPharma
to provide tailored training programs on site
for “Introduction to GMP” and “Behavioural
GMP”. Topics covered in “Introduction to GMP”
included Manufacturers’ Obligations; Role of
the TGA; GMP Principles for Manufacturing
Operations; and Pharmaceutical Quality
Systems. The course on “Behavioural GMP”
looked to focus on how to minimise human
error addressing company culture and the
systems in place to influence and support
changed behaviour.
“The training SeerPharma has provided has
been relevant, with quality content and well
received by all participants. This training has
improved our employees knowledge and been
easily applied to their work.”
Contact us if you’d like more information about
how we can tailor a training program for your
specific needs.
“The training SeerPharma has provided has been relevant, with
quality content and well received by all participants. This training
has improved our employees knowledge and been easily applied
to their work.”
Ben Retallick, Training and Improvement Coordinator, Health World Limited
4 | SeerPharma Journal | April 2015
www.seerpharma.com
Australian medical device manufacturer
approaches SeerPharma for their expertise
on computer system validation
A major Australian manufacturer of medical
devices has engaged with SeerPharma to
deliver a customised program on computer
system validation. The course looks to address
content such as agile processes; cloud
computing and automated testing and draws
on SeerPharma’s experience on the regulatory
(GMP) framework and incorporates case
studies from the manufacturer’s work flow.
The program will be delivered over one day
to 25 staff and specifically addresses the
manufacturer’s concerns such as :
• Computer system validation across
departments from Product Development, IT
and Manufacturing
• Electronic records and signatures
• Validation life cycle processes and
documentation
www.seerpharma.com
Contact us to learn more about our capabilities
with validating computer systems
SeerPharma Journal | April 2015 | 5
Global pharmaceutical company
approaches SeerPharma
to perform audits
A US-based biopharmaceutical
firm has approached SeerPharma
to perform audits of their critical
service providers. The company
is about to undertake a phase I
clinical trial in Australia of one of
its therapeutic molecules.
The firm utilises a variety of
Australian facilities to perform
clinical trials; manufacturing
and
formulation
of
their
investigational product; and the
final filling of product. As part of
its regulatory obligations as the
sponsor of the trial, the company
must ensure compliance with
Australian and US regulatory
requirements, along with all
relevant international codes of
practice.
SeerPharma
have
been
requested to perform an audit of
its:
• CRO
• Manufacturer
• Finish and Fill Facility
• Clinical Site
• Clinical Trial Sample Storage
and Distribution Provider
• BioAnalytical Testing Site
Contact us if you’d like more
information on our expertise with
auditing facilities that have an
impact on your product quality.
6 | SeerPharma Journal | April 2015
www.seerpharma.com
Multinational pharmaceutical
company commits to further online
GMP training from SeerPharma
A multinational pharmaceutical company has
been using SeerPharma’s web-based GMP
E-learning solution for new employee and
refresher training since October 2012. With
additional staff coming on board, SeerPharma
has altered the implementation model to
provide the client with more functionality as
well as the independence to self-manage the
training within SeerPharma’s online Learning
Management System (LMS).
In addition to the automated assessments,
benefits such as exception reporting for failed/
expired training activities deliver further time
savings for the company so they can redirect
resources to more value-adding tasks.
SeerPharma E-learning GMP module 1: Introduction to GMP
Leading Australian natural health brand
implements SeerPharma GMP e-learning
After reviewing the market with a project to
replace their existing GMP induction and
refresher training program, our newest client
has recognised the value of SeerPharma’s
GMP E-learning solution. Specifically for
their implementation, they needed a training
program that could be effectively integrated
directly into their own LMS to ensure they
maintained all training records in the same
system. With 10 modules and assessments
available as off-the-shelf items, SeerPharma’s
GMP E-learning solution delivered on that
requirement. The client was able to have the
program operational extremely quickly with the
added benefit of having total control of within
their own LMS.
www.seerpharma.com
SeerPharma Journal | April 2015 | 7
GMP Training provides
excellent career pathways
University of Technology, Sydney (UTS) has
partnered with SeerPharma, Asia/Pacific’s
leading provider of technical compliance
and QA knowledge, to develop postgraduate
courses in Good Manufacturing Practice
(GMP).
Offered from 2015 as part of the UTS Graduate
School of Health discipline of Pharmacy, the
Masters, Graduate Diploma and Graduate
Certificate courses are unique in Australia and
the Asia-Pacific region.
SeerPharma Managing Partner Brad Roberts
says the courses have been designed to
address an unmet need for industry. “The
units of study cover all stages of the product
life cycle from pre-clinical and clinical through
to commercial manufacturing. An organisation
with GMP graduates from UTS will be
better placed to expand their manufacturing
operations in places like Indonesia, India,
Pakistan, Malaysia, Vietnam, China, Singapore
and the Middle East while ensuring that they
comply with the regulatory frameworks of the
countries they export to.”
“Graduates will have expert knowledge of
Quality and Good Manufacturing Practice to
meet TGA, FDA, EU and PIC/S requirements,
and will have the option to specialise in a
chosen stream. This gives students the
flexibility to tailor their qualification to their
career aspirations.”
Industry based research projects supervised by
UTS pharmacy academics may also be offered
to students on the basis of availability and
merit, helping students to build relationships
with local industry.
8 | SeerPharma Journal | April 2015
Associate Professor of Pharmaceutical
Science Mary Bebawy describes the courses
as “contemporary and innovative; integrating
research and academic rigour with the practicebased approach that UTS is well-known for.”
“UTS has a strong program of research in
pharmaceutical science – particularly in the
area of oncology and respiratory science and
the introduction of these programs will only
strengthen this further. The course content is
grounded in cutting-edge research, but is taught
by industry based experts who have spent
many years working with pharmaceuticals,
biologics and/or medical device companies. To
me, this is the perfect combination to empower
capable, work-ready graduates – research-led
but with a practice-based execution.”
David Spaulding, SeerPharma Training
Manager attributes the partnership to UTS’
strong reputation as being good to do business
with. “We partnered with UTS because they
understand the sector and they know how to
work with industry.”
Applications for 2015 are open now. For more
information, visit: www.gmp.uts.edu.au
www.seerpharma.com
Our perspective on manufacturing
in the pharmaceutical and
medical device industry
The Pharmaceutical and Medical device
industry in Australia and Singapore has
undergone significant change over the last
decade and continues to evolve, due to a
strong local currency and the emergence
of manufacturing capabilities in Asia. We’ve
observed a general trend for more and more
companies operating as virtual companies;
where manufacturing, clinical trials, packaging,
logistics and distribution are being outsourced
to companies in Asia, the EU, US and even
here in Australia.
Although this trend means a decline in out-andout manufacturing, firms are still accountable
for the quality of their product and ensuring that
their systems and processes are compliant to
the relevant regulatory authorities in which
they market and sell their products.
www.seerpharma.com
Our meetings with such clients have led to
fruitful discussions on managing the complex
paper trail created from having outsourced
suppliers and the dilemma of not having
authority over quality control with these entities.
From these discussions, we’ve been
requested to assist with auditing suppliers
here and overseas. Plus provide software
solutions to automate and track paper records
from clinical trials, manufacturing site(s) and
logistic providers. We’ve also noted a number
of logistics companies approaching us for
greater assistance on how to handle regulatory
requirements of pharmaceutical and medical
device manufacturers.
These are exciting times ahead, as we evolve
with the new paradigm in pharmaceutical and
medical device manufacturing.
SeerPharma Journal | April 2015 | 9
SeerPharma Journal
Events that we will be attending in the next quarter:
Event
AusMedTech
ARCS Congress
pharmaceuticals
Dates
29th - 30th
April 2015
5th - 7th
May 2015
Venue
Pullman Melbourne on the Park Hotel, Melbourne
Royal Randwick Racecourse, Sydney
medical devices
other industries
life sciences
Australia
SeerPharma Pty. Ltd.
Suite 2, Level 1
38-40 Prospect Street
Box Hill, Victoria, 3128
Australia
+61 3 9897 1990
[email protected]
Asia
SeerPharma (Singapore) Pte. Ltd.
10 Anson Road
#20-05 International Plaza
Singapore 079903
+65 6774 5800
[email protected]