Compliant Manufacturing

Transcription

1 September 11 th 2014 Compliant Manufacturing Hospira journey to the electronic batch record and device traceability

2 Global Leadership Position #1 in Generic Injectables #2 in Devices Market Value: $9B Market Value: $2B Hospira Fresenius Hikma Pfizer Novartis Sagent Sanofi Baxter Other 2% 2% 3% 4% 25% 8% 12% 34% Hospira 11% 5% 4% 1% 16% 9% 25% Hospira 29% Hospira CareFusion Baxter B. Braun Smiths Fresenius Terumo Other 10% Global Generic Injectable Market (Units)* Global Devices (MMS) (Units) 2 SIP: Market share represents the unit market of genericized products in which Hospira participates for the U.S., EU5, Australia, Japan, South Korea and Canada. IMS NSP (U.S.) data as of Jan 29, 2013, IMS MIDAS (ex-u.s.) data as of Feb 27, 2013, Share figure represents rolling four quarter data (Q112- Q412). Data excludes the retail channel in the U.S.and other markets. Market value is for Hospira s served available market. IMS Geographies: U.S., Canada, Australia, EMEA (France, Italy, Spain, UK, Turkey, Saudi Arabia), LATAM (Argentina, Brazil, Colombia, Chile, Mexico, Peru), Asia (China, Taiwan, Hong Kong). Devices: LVP, Ambulatory, PCA. Includes devices Hospira sells. Source: MDI, Dec. 2012; inmedica: The World Market for Infusion Pumps and Accessories (2011); inetand Hospira internal analysis.

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7 Some things I hope you will take away What is it that s unique and will make a major impact for Hospira Why has it taken a while (and cost a lot ) How this investment will drive value after the project How do we transform regulations in competitive advantage (ie can you fall in love with a label?) Lessons learned 7

8 Simplified process flow: producing and delivering high quality drugs and devices while meeting compliance requirements is a challenge Planners Service Center DEVICE MANUFACTURING PLANT DRUG MANUFACTURING PLANT Distribution Centers CUSTOMERS

9 Hospira journey to an electronic batch record for the device consumables business: the business drivers Better and More Efficient Compliance Eliminate Paper where possible Reduce mistakes / errors Real time entry no transcribing Mistake proof data entry Reduce batch audit cycle time Ability to change easily with changes in the business Flexible master data, minimal IT involvement Effective and complete training for local users and IT Make sustainable for new employees Make Local IT effective first level support Improved Reporting System level reporting / less off-line calculations

10 12.2% 10.9% 9.5% Manual Batch record Distribution of Error Typologies Occurrence of different Error Typology in typical Paper Based Executed Batch Record (% of Error Typology) 30.0% 28,1% 25.0% 20.0% 15.0% 10.0% 7.2% 6.7% 5.9% 5.6% 5.3% 5.0% 2.2% 2.0% 2.0% 0.9% 0.5% 0.3% 0.2% 0.2% 0.1% 0.0% Missing BOM Holding time Calculation error Wrong Attachment numbering Incomplete record Wrong Data Recorded Wrong Reconciliation Missing Date Attachment not filled-in Attachment not verified Missing Attachment Attachment not correctly referenced Missing checkbox Anomalous sequence of BR fulfillment Missing data Over-writing/Bad GMP Correction Not clear writing Missing Signature Wrong BR fulfillment

11 Before / After A Dramatic Transformation 11

12 The Challenge Documents to Data 12

13 Hospira A Company of Documents GMP Documentation Process Specifications Test Specifications Material Specifications Stability Specifications Labeling Specifications Standard Operating Procedures Challenges Different formats across sites No relation to Data Paper based processes Shift in paradigm to data Specs, SOP s, Forms 13

14 Documents to Master Data Mapping GMP Documentation Process Specifications Test Specifications Material Specifications Stability Specifications Labeling Specifications BOM Specifications Master Data Master Recipe Operations Master Recipe BOM Material Master Inspection Plans Specs, SOP s, Forms 14

15 What is an Electronic Batch Record (EBR)? Equipment Log Hold Times BOM X-Steps Master Recipe Quality Data Material Movements Environmental Log Weigh & Dispense Batch Exceptions Maintenance Log Parameters Log QM Results Log Analyze/Enable Batch Execution 15

16 Plant Feedback Achievements Data Entry and Processing Documentation errors per batch have been reduced to almost zero due to the structure of data for entry. Quality results recording for in-process inspections time has been reduced by approx. 20%. Printing paper has been reduced between 70 to 90%. Only a few docs are printed when needed, previously ALL DOCS were printed. Line assistants and clerks are available to spend more time on manufacturing activities. Previously, they entered the inspection setup for each lot, which is now master data (one time set-up). 16

17 Plant Feedback Achievements Batch Release Process The time to audit a batch record it is taking approximately 30% less time should increase as comfort/proficiency with the system grows. Manufacturing Quality review has gone from 30 min down to 10 min per batch. Batch final release time has decreased significantly by eliminating duplicated reviews. 17

18 What did we get out of this: product traceability Step 1: visualize the batch history. How did we make that batch, where did we ship it. Step 2: drill down into the supply chain Step 3: drill down into the manufacturing process. 18

19 Can you fall in love with a label?

20 Things to consider Project Lessons Learned Begin execution of business simulations runs much earlier in the project lifecycle Include security roles in testing as early as possible Increase co-location time of functional and business resources Earlier and better integration of training team SOP authoring is a risk to the project timeline Master data management in the business centralized vs distributed Identify and backfilling local subject matter experts is not enough 20

21 Thanks Vice President of IT

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