The document summarizes a report by CPhI that warns the pharmaceutical industry must actively drive process improvements itself in order to meet growing global demand. The report found that 70% of companies are investing in manufacturing and 59% plan to increase staffing. However, the report states that for significant cost savings to be achieved, improvements must be led by the industry itself rather than regulators. It concludes that if one major pharmaceutical company successfully implements process perfection from development through commercialization, others will follow suit.

1. VPO Press Release - CPhI Report Warns Industry Must
Actively Drive Process Improvements Itself to Meet Growing
Global Demand
AMSTERDAM, April 24, 2014 /PRNewswire/ --
Improved process efficiency, with modern manufacturing techniques could save billions and increase
profits, improve quality and open up sales in developing markets
Girish Malhotra, CPhI expert panel view: "'Process centricity' has to overtake the current 'regulation
centricity' if pharma wants to see cost reductions in new and existing processes."
(Logo: http://photos.prnewswire.com/prnh/20130723/629764-a )
Report highlights:
Manufacturing efficiencies must be driven by big pharma, not regulators as this will only increase
costs
'Improving product quality' and 'reducing manufacturing costs' are the industry's major priorities
70% investing in manufacturing this year, with 59% also hiring more staff
59% are increasing the use of outsourcing
Nearly 50% of the industry stated they introduced more than three products last year, with a further
41% adding 1-3 products
'Improved efficiency' and 'improved safety' were highlighted as the most important manufacturing
goals
CPhI Worldwide, part of UBM Live's Pharmaceutical Portfolio, announce the findings of its Pharma
Insights report on Manufacturing. Overall the report indicates that the industry is aware of the need
to continue to improve manufacturing practices, processes and efficiencies to dive down costs and
improve profits and drug quality. However, the report warns that industry must more actively take
the lead if we are to see these vital changes driven through- currently, the inertia of the existing
model is impeding innovation and preventing wide spread adoption.
CPhI adds that most of the sector now states it is utilising continuous process improvements to drive
efficiency savings, but more could be done to revolutionise practices. CPhI findings show that 26%
are using 'statistical process control', 21% using 'process capability analysis', 16% QbD, 12% 'six
sigma' and 11% using both 'lean/kaizen' and 'PAT'. Furthermore, many are building for the future
and making essential upgrades to existing equipment with 70% actively investing in manufacturing.
In the medium to long term, we should see a cross-pollination of process improvements from

2. generics (where costs savings can still be made) though CMOs and ultimately into big pharma's
patented products. The advantage here is that lower cost patented products would open huge new
markets, whilst reducing the attractiveness of counterfeits.
For cost savings to be made however, the report clearly states further improvements must come
from the industry itself and not the regulator, as this will only increase costs.
CPhI panel member and President of EPCOT International Girish Malhotra, added: "Not much will
change in the current processes as the needed regulatory approval will come in the way of any
improvement of existing processes. Success to exceed regulations will only come from process
inception stage along with command of the process as they become commercial. 'Process centricity'
has to overtake the current 'regulation centricity' if pharma wants to see cost reductions in new and
existing processes."
In terms of the industry's economic strength, the findings show the sector is in good health with 59%
planning to increase headcount this year and only 4% planning reductions. In outsourcing we
continue to see increases with 41% outsourcing more of their manufacturing. Going forwards, if
manufacturers want to improve product quality, they must find a supplier that aligns with their own
GMP compliance expectation.
Additionally, nearly 50% of the industry stated they introduced more than three products last year,
with a further 41% adding 1-3 products.
The biggest manufacturing goals are to 'increase efficiencies' and 'safety' and already 89% are
testing raw material sourced- with 'compendial testing' by far the most favoured method (81%).
"With the majority of the industry now committed to process improvements and increased product
quality the next few years will hopefully see more new manufacturing methods coming to market,
with tighter process controls - these should ultimately reduce costs and increase profits for the
industry." Chris Kilbee, Group Director Pharma.
CPhI believes we may be at the cusp of a revolution and if one major pharma company starts reaping
the benefits of implementing process perfection from initial development to commercialisation
others will follow. Drawing all these findings together the report concludes that the industry has
made great strides and with new efficient techniques drugs should be more available globally at
reduced cost, enabling developing countries increased access.
Chris Kilbee added: "The desire to modernise processes across the industry is clearly there and
taking a long term view we can see that the way we conduct development work right through to
commercialisation has the chance to revolutionise the business model. Patented products will be
opened up to a wider number of the globe's seven billion inhabitants, which is a real human goal, but
also one that will see the industry become more sustainable and increase profits. I believe that with

3. these commitments we see a situation where industry actively drives improvements and takes these
new methods to the regulator- cost savings and improved quality should go hand in hand".
Full report:
http://www.cphi.com/documents/129623/1317492/CPhI+Pharma+Insights+Report-+Manufacturing.
pdf/2fe19c18-9641-4a60-9846-4fbb561cb8a6
About CPhI
CPhI drives growth and innovation at every step of the global pharmaceutical supply chain from
drug discovery to finished dosage. Through exhibitions, conferences and online communities, CPhI
brings together more than 100,000 pharmaceutical professionals each year to network, identify
business opportunities and expand the global market. CPhI hosts events in Europe, China, India,
Japan, Korea, Southeast Asia, Istanbul, Russia and South America and co-locates with ICSE for
contract services, P-MEC for machinery, equipment & technology, InnoPack for pharmaceutical
packaging and BioPh for biopharma. CPhI provides an online buyer & supplier directory at CPhI-
Online.com.
For more information visit: http://www.cphi.com
The UBM Live annual schedule of Pharmaceutical events also includes CPhI Russia and IPhEB (16-
17 April, 2014 at the Lenexpo Exhibition Complex- St Petersburg, Russia); CPhI, P-MEC and
Innopack South East Asia (20-22 May, 2014 at the Jakarta International Expo- Jakarta, Indonesia);
CPhI Istanbul (4-6 June, 2014, at the Lutfi Kirdar Convention and Exhibition Centre- Turkey); CPhI,
Hi and Fi, ICSE, P-MEC, BioPh and LabWorld China (26-28 June, 2014 at SNIEC- Shanghai, China);
CPhI South America (5-7 August 2014 at Expo Centre Norte, Sao Paulo- Brazil); CPhI, ICSE Korea
(2-3 September, 2014 at the COEX- Seoul, South Korea); CPhI, ICSE, P-MEC and InnoPack
Worldwide (7-9 October 2014, Paris Nord Villepinte- France); CPhI and P-MEC India (2-4 December,
2014 at the Bombay Exhibition Centre- Mumbai); CPhI, ICSE, P-MEC, BioPh and Pharmatec Japan
(22-24 April, 2015 at the Big Sight Exhibition Centre- Tokyo).
About UBM Live
UBM Live connects people and creates opportunities for companies across five continents to develop
new business, meet customers, launch new products, promote their brands, and expand their
market. Through premier brands such as TFM&A, Internet World, IFSEC, MD&M, CPhI, Cruise
Shipping Miami, the Concrete Show, and many others, UBM Live exhibitions, conferences, awards
programs, publications, Websites, and training and certification programs are an integral part of the
marketing plans of companies across more than 20 industry sectors.
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