Business Continuity Planning Process Cilag AG Schaffhausen. Dr. Urs Krebser
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1 Business Continuity Planning Process Cilag AG Schaffhausen Dr. Urs Krebser
2 Johnson & Johnson Switzerland Headcounts (2008) Total HC 2900 Schaffhausen Cilag AG Cilag A.T. GmbH HC 1100 Spreitenbach Johnson & Johnson AG HC 170 Activities Manufacturing R&D / Sales Activities Sales (Local Distr.) Le Locle / Neuchâtel Activities Medos Codman Ethicon DePuy Ace - Mitek - Spine Obtech Medical FMS S.A. HC 1010 Manufacturing R&D Sales Baar Janssen-Cilag AG HC 120 Zug Cilag GmbH International Cilag Holding AG Activities Sales (Local Distr.) Activities Sales Supply Chain Johnson & Johnson Swiss Finance Ltd. Treasury HC September 2008 Wirtschaftliche Landesversorgung 2
3 Intro Schaffhausen Schaffhausen 9. September 2008 Wirtschaftliche Landesversorgung 3
4 General Information Part Company Founded in Schaffhausen 1959 Johnson & Johnson Ownership Pharmaceutical and Chemical Operations on Site R&D operations on Site ca employees 9. September 2008 Wirtschaftliche Landesversorgung 4
5 Product & Technology Overview Technology / Process Aseptic-Lyophilised vial Aseptic-Liquid pre fill-syringe Aseptic Liquid Vial Tablets Oral Contraceptives Semi Solids / Creams Medical device Product REMICADE Diluent for RISPERDAL CONSTA EPREX EPREX TOPAMAX PARIET CILEST / TRI-CILEST OVYSMEN / MICRONOR RETIN A PERDOLAN Suppo s PEVISONE ASP STERRAD Cassettes 9. September 2008 Wirtschaftliche Landesversorgung 5
6 Cilag Schaffhausen Operations, Switzerland (Cilag AG) CHEM. R&D CHEM. SCALE-UP / PILOT PHARMA. DEV (J&J Pharma R&D) $ CHEMICAL MFG PHARMA MFG 9. September 2008 Wirtschaftliche Landesversorgung 6
7 Pharma Operations Europe - 5 sites Val de Reuil Cashel Beerse/Olen Schaffhausen Latina Each site has its own manufacturing mission with specific technical focus 9. September 2008 Wirtschaftliche Landesversorgung 7
8 Chem Operations WW - 6 sites Athens Cork Willmington Geel Schaffhausen Tasmania 9. September 2008 Wirtschaftliche Landesversorgung 8
9 Cilag Site Overview PHARMA OPERATIONS SITE & INFRA- STRUCTURE CHEMICAL OPERATIONS 9. September 2008 Wirtschaftliche Landesversorgung 9
10 CILAG Schaffhausen Main Site 9. September 2008 Wirtschaftliche Landesversorgung 10
11 Incoming Warehouse CILAG SCHAFFHAUSEN OPERATIONS Chemical Product Handling Center Distribution Warehouse CILAG Schaffhausen Off-site Office Building Main Site ASP STERRAD Cassettes Manufacturing 9. September 2008 Wirtschaftliche Landesversorgung 11
12 BCP Background 2004: Johnson & Johnson created as a result of 9/11 and the Emergency Preparedness Task Force championed by Russ Deyo & 2005: All critical J&J manufacturing sites adopted program and developed a BC Plan. 2006: Lean BCP introduced reducing the amount of time and resources spent on plan development and conducting table-top exercises. BCP made optional at the discretion of operating company management. Distribution Centers and critical offices adopted program and developed a BC Plan. 9. September 2008 Wirtschaftliche Landesversorgung 12
13 Cilag BCP Concept Cilag has ONE CMT organization CMT core team meets monthly CMT Trainings sessions: June 2005 with Kantonalem Führungsstab June 2006 preparation for 70 Jahre Cilag event Planned 2009 with Blau-Licht Organisation SH Cilag has TWO Recovery Plans, one for ChOP, one for Pharma ChOP implemented a WW Recovery Plan J&J follow-up on BCP by so called Table-Top exercises Last TT Jan 2005 Next Q September 2008 Wirtschaftliche Landesversorgung 13
14 Recovery Action Plan and Workbook I Organization List of names, addresses and phone numbers Part Red Emergency Response Flow Chart Pre-prepared Scenarios Part Yellow Incident Management R&R and Flowcharts 0 2 hours after event within 6 hours within 12 hours within 24 hours within 48 hours Communication Crisis Plan (Logistics support, Human resources, Risk Management, Records Management, Regulatory Affairs) 9. September 2008 Wirtschaftliche Landesversorgung 14
15 Recovery Action Plan and Workbook II Part Green Recovery Flow Charts for within 1 2 days Review situation within 2 7 days Recovery strategy within 7 14 days Activate pre-established alternate capacity within 2 4 weeks Confirm Process / equipment compatibility within 4 8 weeks Start process transfer to alternate Sites within 2 3 months Support alternate Sites during Transfer within 3 6 months Complete full activation of alternate Capacity Within 6 18 months Manage Cilag re-construction Within months Trial production and validation 9. September 2008 Wirtschaftliche Landesversorgung 15
16 Recovery Action Plan and Workbook III Part Blue Alternate Capacity Critical Equipment Key Materials/Suppliers IM Contingency Plan Guidance and preparedness for influenza pandemic 9. September 2008 Wirtschaftliche Landesversorgung 16
17 Practical Solutions Back-up Utilities 1. Electro Two external 10 kv supply lines, separate Unterwerke One 1.8 MW un-interrupted power supply unit (fly-wheel) One 2.5 MW Diesel generator USV equipment 2. Gas as main energy supply Back-up lt. oil 9. September 2008 Wirtschaftliche Landesversorgung 17
18 Irgendwelche Fragen, die ich beantworten kann? 9. September 2008 Wirtschaftliche Landesversorgung 18
19 Organization Fire/Explosion Chemical Spills Accidents Security Issues Public Disturbances Authority Actions Product Alert Recall Emergency Response Team (ERT) OCT (Einsatzleitung); Incident Commander Deputy ERT Group-leaders CMT Core-Team Managing Director CMT Lead Chief Communication Crisis Management Team (CMT) Managing Director CMT Lead Chief Communication VP Human Resources GM Pharma Ops GM Chem Ops Head R & D CFO CIO 9. September 2008 Wirtschaftliche Landesversorgung 19
20 Emergency Response Flow Chart 9. September 2008 Wirtschaftliche Landesversorgung 20
21 R & R Incident Management 9. September 2008 Wirtschaftliche Landesversorgung 21
22 Recovery Flow-Chart 9. September 2008 Wirtschaftliche Landesversorgung 22
23 Alternate Capacity 9. September 2008 Wirtschaftliche Landesversorgung 23
24 Critical Equipment 9. September 2008 Wirtschaftliche Landesversorgung 24
25 Key Materials 9. September 2008 Wirtschaftliche Landesversorgung 25
26 Pandemic Plan 9. September 2008 Wirtschaftliche Landesversorgung 26
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