CPhI Report Warns Industry Must Actively Drive Process Improvements Itself to Meet Growing Global Demand

Amsterdam (ots/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 [http://www.cphi.com ], 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 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 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+Pha
rma+Insights+Report-+Manufacturing.pdf/2fe19c18-9641-4a60-9846-4fbb56
1cb8a6

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 ; CPhI and P-MEC India (2-4 December, 2014 at the Bombay
Exhibition Centre- Mumbai); CPhI, ICSE, P-MEC, BioPh and Pharmatec
Japan .

About UBM Live

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Through premier brands such as TFM&A, Internet World, IFSEC, MD&M,
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