IPSEN Company Profile 2020 (Premio Shingo-Signes, SUD, Francia)
IPSEN Company Profile 2020 (Premio Shingo-Signes, SUD, Francia)
IPSEN Company Profile 2020 (Premio Shingo-Signes, SUD, Francia)
Corporate Overview
Ipsen is a global specialty‐driven biopharmaceutical company with total sales The manufacturing, maintenance and warehouse teams work on 2 shifts 5
over €2.5 billion in 2019. Ipsen sells more than 20 drugs in over 115 days a week. Some of our processes work 24/7 and are monitored by a
countries, with a direct commercial presence in more than 30 countries. specific organization. All quality testing and release steps are performed on
Ipsen’s vision is to become a leading global biotech company focused on site.
innovation and specialty care (oncology, rare diseases and neurosciences). The site has also integrated large Engineering department and Industrial
The 3 Pillars of Ipsen’s strategy are: building a robust pipeline, accelerate Development teams to improve robustness and knowledge of current
growth in specialty care and increase penetration in strategic markets. processes and introduce efficiently new products.
Moreover, the Group has an active policy of partnerships. Ipsen's R&D is
focused on its innovative and differentiated technological platforms, Pharmaceutical Quality System
peptides and toxins. In 2018, R&D expenditure exceeded €300 million, Our Quality System ensures quality of all our processes, from the raw
representing 14% of Ipsen sales. Ipsen Group has about 5,700 employees materials receipt to the finished products shipment. It governs quality testing
worldwide. and release of raw materials, intermediates and finished drug products.
Ipsen Pharma Biotech The overall Quality System also ensures compliance of our activities with the
Ipsen Pharma Biotech (also named Ipsen Signes) is a drug product highest standards of GMP and GDP regulations (Good Manufacturing and
manufacturer, set up in Signes town in 1990. Our site produces more than Good Distribution Practices) in force in the main geographical areas
3,5 million boxes of sterile drug products per year distributed to more than throughout the world: US Food and Drug Administration (FDA, USA),
70 countries to improve patient lives. Our products alone represent close to European Medicines Agency (EMA, EU), Pharmaceuticals and Medical Devices
60% of the Group’s turnover. Agency (PMDA, Japan), ANVISA (Brazil)…
Ipsen Pharma Biotech is now one of the Ipsen Group’s most strategic sites
and has benefited from substantial investments (20M€ each year) to support
our production growth (45% in the past 5 years) and guaranteeing the “best
in class” technologies for new product introduction.
The site has around 300 employees and subcontractors, who are fully Operational Excellence
committed in the different stages of the product transformation, from the In 2005, Ipsen Pharma Biotech started its global Lean journey based on a
active ingredients (coming from our Dublin site) into medicines. specific set of tools and focusing on operational units: 5S, TPM, OEE, SMED
and Lean Lab.
In 2008, the program has been extended to all site’s functions by leading a
large Six Sigma program: training White, Yellow, Green and Black Belts and
conducting Lean 6 sigma projects.
In 2011, the site decided to further embrace continuous improvement in the
daily behavior of each member staff, by deploying the Visual Management in
every team, the problem‐solving management and standard work. It has
been decided also to increase the enterprise alignment and the breakthrough
initiatives by using the VSM and the Hoshin Kanri (HK) processes.
In 2013, Ipsen Pharma Biotech was the first site among Ipsen to introduce the
Shingo Model through an external assessment. Maturity progress has been
Products and processes periodically reviewed (every 2 years). It has allowed both to define our
Our site’s mission is to produce innovative injectable drugs for our patients. Operational Excellence road map and to build our Ipsen Excellence Model
Two of the group’s three flagship products are manufactured here. which is very inspired from Shingo Model.
Decapeptyl® is mainly indicated for prostate cancer hormone therapy, but it
is also used in gynaecology.
Somatuline®, is key in the treatment of advanced neuroendocrine tumors as
well as the symptoms of acromegaly.
In addition to that, Nutropin® treats growth hormone deficiency for children
and adults and we are about to introduce a new product, Onivyde® to treat
pancreatic cancer.
The site is categorized as an injectable/sterile manufacturing site. The main
process flow is as follows:
Quality release
Warehousing Sterilization (SF
control and
(Procurement) good)
visual inspection
Secondary
Weighing &
Freeze‐drying packaging
mixing
(Finished good)
Additional process
operations such as Primary Warehousing
Extruding/Grinding, packaging (Shipping)
Sieving, encapsulating...
Our People Morale/People:
The site decided since 2012 to involve every employee in strategic decisions ‐ People engagement increased by 20%
by leading or participating to Kaizen events, Workshops and yearly seminar. ‐ Achieving a score of 96% in Shingo survey done by The Manufacturing
Every employee has committed to the decisions made together. Institute
‐ Recognition: 446 e‐thank you cards, 1050 thank you cards and about 180
Way of being and Kaizen awards delivered to our associates
‐ Less than 1% of staff turnover
‐ Personal Development Meeting (PDM) process for every employee every
year
‐ About 30 hours of training per employee each year
‐ Internal mobility increased from 1 to 7%
‐ Staff wellness program covering many fields: Pilates, yoga, running …
Indeed, every employee is engaged to make his daily work better by
‐ Diversity and inclusion (total equality men/women in our management
implementing his ideas through the Ideas Generation process.
staff)
Recognition and mutual respect are also important pillars.
‐ Organizing every 2 years the site family days for our associates
Employees use thank you cards to recognize ideal behaviors of their
‐ Around 15 CSR activities (charity) done by our associates and mainly for
colleagues. The site recognizes every quarter the best ideal behaviors and
our final customer, our patients (Movember, Rire medecin charity org)
Kaizen initiatives.
ACHIEVEMENTS in last 5 years
Safety, Health & Environment: Operational Excellence:
‐ Zero lost time accidents during more than 1200 days ‐ All employees are at least White Belt certified, induction process in place
‐ 100% successful inspections ‐ All employees are trained on advanced problems solving (Kepner Tregoe)
‐ ISO14001 (environment),18001 (safety) and 50001 (energy) certifications ‐ All managers and process leaders are at least Yellow Belt (70), 17 of them
‐ From 65 to 300 acting near misses are Green Belts and 6 of them are Black Belts
‐ Water consumption reduced by 35% ‐ More than 400 OE standards in place
‐ More than 300 problems solved/year using the right approach
‐ Electrical consumption reduced by 30%
‐ All employees involved through Kaizen or DMAIC projects
‐ 100% of wastes recycled ‐ 10 DMAIC and 5 Kaizen events/year in average coming from the Hoshin
Quality: Kanri
- 100% successful inspections and customer audits ‐ About 5 sites benchmarking each year and 3 University collaborations
- From 72% First time quality to 90% in SFP, about 97% for total production ‐ From few to more than 1000 CI ideas generated by associates a year
- From 5.5% deviation ratio to less than 3.9% Awards:
- From 72% CAPA on time to more than 92% ‐ Winner of Ipsen group Safety Award for 2018 for zero lost time accidents
‐ Winner of the Ipsen group simplification award in 2015 and 2016
- From 30% to 95% change control actions completed on time
‐ Winner of the Ipsen Enterprise Excellence award in 2018
- Achieving a decrease of batch rejection to 1 batch in full year ‐ Winner of Government CSR Prize in 2018
Productivity/Cost: ‐ Winner of the best company of the region in 2018 (Made in Var prize)
‐ Cost per unit reduced by 55% ‐ Finalist to the best company for HR initiatives 2018 (Usine nouvelle prize)
‐ Productivity increased by 14%
‐ Sales increased by 67%
‐ 10 M€ of Continuous improvement savings (Kaizen, projects, ideas)
‐ Overall Yield increased from 93% to 94.5%
‐ OEE increased for our main bottleneck streams by 25%
‐ Reaching the Capex Landing at +/‐3% for 3 consecutive years with approx.
20 M€ of spending capex (for compliance and capacity growth)
Delivery:
‐ 100% On Time In Full since May 2016 (delivery in the week)
‐ 0 out of stock
‐ Increase the production Adherence plan from 90% to 98% Contact: Amayas Benkaroun
‐ Reduce the time to market to 2 weeks through JIT in Packaging Head of Enterprise Excellence
‐ 93% of project delivery milestones achieved on time Tel: +33 6 84 53 33 45
Customer: Email: [email protected]
‐ Internal customer satisfaction increased by 32%
‐ Customer complaints at 5.5 sigma level (32 PPM)
‐ The Decapeptyl® product demand has shown a growth of 23%
‐ The Somatuline ® product demand has shown a growth of 107%
‐ 0 product Recall
‐ Market geographical footprint increased by 30%
‐ Achieving the launch of a new device for Somatuline® without any
shortage
‐ Organizing more than 10 sites visits for Doctors (Stakeholders)