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Due Diligence Audit By Pinky Bhat & Prashant K. , ISS

Due Diligence Audits at Pharmaceutical contract Manufacturing Sites in India - Lessons Learned

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Due Diligence Audit By Pinky Bhat & Prashant K. , ISS

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  1. International Safety Systems, Inc. Due Diligence Audits at Pharmaceutical contract Manufacturing Sites in India - Lessons Learned Prasanth.K, Deputy Project Manager, India Pinky Bhatt, Project Manager, Asia-Pacific International Safety Systems, Inc. (ISS), India www.issehs.com

  2. AGENDA • Pharmaceutical growth in India • EHS status at Contract Manufacturing sites • EHS audit objectives and methods • Observations • Outcomes • Lessons Learned www.issehs.com

  3. EVOLUTION OF INDIAN PHARMA INDUSTRY

  4. India – Major focus for Contract Manufacturing According to a study in 2013, India is: • 4th in the world in terms of production volumes • 13th in domestic consumption • Over 55% exports of India are to highly regulated markets • Largest exporter of formulations in terms of volume with 14 % market share www.issehs.com

  5. Contract Manufacturing Sites-EHS Status • Expert in manufacturing APIs and Formulations • Limited EHS resources • Competent professionals with competency in IH and Process safety • Understanding of IH significance especially for high potent compounds • Trained mentors such CIHs • Willingness to learn and change • Safety and environmental compliance is little better – IH Process Safety needs significant improvements www.issehs.com

  6. EHS Audits • Due Diligence audits for • Potential suppliers • With QA/QC Team • EHS Assessments for • Existing Suppliers • API Manufacturing sites • Formulation sites • Vaccine plant www.issehs.com

  7. EHS Audits Conducted • India: • Tarapur, Hyderabad, Goa, Mumbai, Visakhapatanam, Ahmedabad, Solapur, Cuddalore, Chennai, Renukoot, more cities • China (Two sites) • Thailand (One site) • Malaysia (One site) • Indonesia (One site) • Egypt (One site) www.issehs.com

  8. EHS Audits Conducted • Germany • Leverkusen • Dessau-Wörlitz • Ireland • Arklow • France • Calais • Spain • Barcelona • Ukrain • Hungary (Budapest) www.issehs.com

  9. EHS Audits Conducted • USA • Rancho Cordova, CA • North Bend, LA • Hickok, KS • Canada • Hamilton • Brazil (two sites) www.issehs.com

  10. EHS Audit Objectives • Evaluate compliance status with local health safety and environmental regulations • Evaluate site status with Pharmaceutical Supply Chain Initiative, http://pharmaceuticalsupplychain.org/ • Evaluate site status on generally accepted industry practices for EHS www.issehs.com

  11. EHS Elements Covered • EHS organization and staffing, Employee EHS training • Air Emissions, Wastewater Management, Waste Management, Spill Prevention • Hazard Assessment, Risk Assessment and Industrial Hygiene Program • Process Safety Management • Emergency Response and Planning • Personal Protective equipment -Written programs, Cleaning and decontamination, Gowning de-gowning www.issehs.com

  12. EHS organization and staffing • EHS Staffing and Competencies • Health, Safety, Environment Policy • Safety committees • Accidents reporting and investigation • Training matrices and training conducted www.issehs.com

  13. Air Emissions, Wastewater Management, Waste Management, Spill Prevention • License to operate • Permits • Pollution control • Waste water treatment, Water discharge, sampling, sludge solid handling • Liquid and solid waste handling • Used container, packing material handling and disposal • Hazardous waste handling and disposal www.issehs.com

  14. Risk Assessment and Controls • Hazard Communication, Chemical Inventory, Labeling, MSDS • Risk Assessment procedures, Follow up • Qualitative and quantitative exposure assessment • Potent compound handling /Particulate containment • Hierarchy of exposure control measures and validation • Equipment and personnel entry and exit • Local Exhaust Ventilation and Preventive Maintenance www.issehs.com

  15. General Safety and Controls • Job Safety Analysis • Permit Systems • Fall Protection • Machine Guarding • Electrical safety and energy isolation procedures • Housekeeping www.issehs.com

  16. Process Safety • Storage, handling and transportation of flammable and reactive chemicals • Storage tanks • Pressure vessels • Safety valves • Control of ignition sources (e.g., static electricity) in flammable area • Inerting, validation of inerting • Compressed gases, boiler and pressure vessels controls www.issehs.com

  17. Life Safety and Emergency Response • Means of egress • Fire Protection Systems and Alarms • Written Plans • Evacuation Procedures www.issehs.com

  18. Evaluation Criteria • Parent company specific guidelines • Local regulations • National and international standards • Best Practices in pharmaceutical industries www.issehs.com

  19. Audit Process followed • Planning • EHS Questionnaire • Site visit (3 to 5 days) • Opening meeting /introduction • Walkthrough • Detailed site visit • Stake-holders meeting (maintenance, Engineering, Physician) • Documents review • Closing conference Draft and final report www.issehs.com

  20. Most Common Observations-Environment • Regulatory • Environment Consent Requirements (quantity of waste generated, disposed off) • Non-regulatory • Determining presence of API in Waste www.issehs.com

  21. Most Common Observations-Process safety and personal safety • Process Safety • Nitrogen inerting not done at all or not validated • Grounding/Bonding and static electricity control measures • Flammable tank/container storage (Dike capacity, flame arrestor) • Personal Safety • Energy Isolation procedures • Fall Protection www.issehs.com

  22. Most Common Observations-Industrial Hygiene • Qualitative Exposure Assessment • Reliable, reproducible and representative quantitative exposure assessment for APIs and solvent • Hierarchy of Controls (RPE reliance) • Robust RPE program • Gowning de-gowning, airlock rooms • Potential contamination of Green Zones www.issehs.com

  23. Outcome • Sites receptive and supportive • Some of the observations addressed immediately • After audits, QLEA and QNEA were conducted with reliable methods • Containment validation conducted as required from parent company • Significant increase in awareness for IH and Process Safety • Basic training conducted www.issehs.com

  24. Lessons Learned • Auditing – especially based on site visit to determine effectiveness of compliance – is powerful tool in ensuring EHS compliance status and reducing EHS risk • Spend more at site at every corner and less in looking at records • Closing meeting – to receive feedback before report goes out is critical • Stay away from commenting audit conclusions such as “show stoppers” until all aspects are considered www.issehs.com

  25. Thank You Questions??

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