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Sustainable EHS program at Pharma supply chain

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Sustainable EHS program at Pharma supply chain

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Sustainable EHS program at Pharma supply chain

  1. 1. RT 229 Global Supply Chain and Social Responsibility-Lessons Learned Developing Sustainable EHS Programs for Pharmaceutical Industry Supply Chain in India and China Maharshi Mehta, CSP, CIH, International Safety Systems, Inc. maharshi.mehta@issehs.com USA-India-China-Mexico-Brazil www.issehs.com
  2. 2. Agenda  Background  Challenges  Approaches Adopted  Lessons Learned  Future  Conclusions
  3. 3. Background  In One study, China and India ranked two most desirable outsourcing countries among Pharmaceutical corporations  More than 200 contract manufacturers (CM) in India  One Pharmaceutical corporation plans to have 30% of their products made by third party  Driving Force: – Low-cost of production and a pool of scientific talents – Price Control “Worldwide revenue for contract manufacturing..pharmaceutical industry estimated at $100 billion in 2004..expected to rise at an average annual growth rate of 10.8% to $168 billion in 2009”
  4. 4. Challenges  CM Concerns: – In-house EHS competency not available – Difficult to implement EHS mandates from parent company – Cost of doing business  Parent Company concerns: – Liability arising out of “holding their hands” – Public image if something goes wrong – Lack of resources – Product interruptions in case of fire or explosions
  5. 5. Approaches  Parents companies conducting EHS audits at CMs  Providing CMs with corporate guidelines  Requiring CMs to comply with local regulations and corporate guidelines  Removing CMs who are grossly violating EHS standards
  6. 6. Approaches – Case Study  Parent company identified major concerns at a CM for process safety and industrial hygiene – Formaldehyde and solvents handled in open blenders  Stopped the process  Locally available consultant (CIH/CSP) assisted CM in risk assessment and controls  Consultants validated controls  Risk reduced, process started
  7. 7. Approaches – Case Study  Under contract with parent company, a qualified locally available consultants conducted EHS audit at 18 CMs  Identified EHS risks  Conducted exposure process safety risk assessments  Based on the findings of assessments, prepared training manual on basic EHS  Conducted train the trainer training for CM representatives  Assisted CMs in EHS with 7/24 helpline from locally available EHS consultants
  8. 8. Approaches-Containment Validation  Parent company requirement from API supplier: – Before supplying API, conduct exposure containment study – Demonstrate API exposure will be below OEL – Then only supply material  Consultant conducted containment validation study  Identified exposures  Recommended controls  Controls are being implemented
  9. 9. Lessons  Providing corporate EHS mandates to CMs and conducting audits alone would not reduce risk at CMs  Sustainable approaches – Empowering CMs by providing basic training on EHS – Training has to be based on potential risk present at CMs – Limited assistance in risk assessment and control – 7/24 helpline – Periodic review – Local availability of reliable consultants – Requiring API suppler to conduct containment validation  Concerns for parent company liability in “holding hands” is reduced if independent and qualified consultants are involved
  10. 10. Future  Ensuring EHS at CMs will continued to be a challenging task  Increasingly parent companies will have to adopt innovative approaches in reducing occupational risks at CMs  Parent companies will have to have local availability of company EHS staff and EHS service providers
  11. 11. Conclusions  To reduce occupational health risk at CMs, requiring CMs to demonstrate exposures below OEL is the best option  Audits from parent company, empowering CMs in EHS and providing limited EHS assistance would reduce the risk at CMs

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