Due Diligence Audit By Pinky Bhatt-Prashant Kondragunta, ISS

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

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International Safety Systems, Inc.:

www.issehs.com 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

AGENDA:

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

EVOLUTION OF INDIAN PHARMA INDUSTRY:

EVOLUTION OF INDIAN PHARMA INDUSTRY

India – Major focus for Contract Manufacturing :

India – Major focus for Contract Manufacturing According to a study in 2013, India is: 4 th in the world in terms of production volumes 13 th 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

Contract Manufacturing Sites-EHS Status:

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

EHS Audits :

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

EHS Audits Conducted :

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

EHS Audits Conducted:

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

EHS Audits Conducted:

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

EHS Audit Objectives:

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

EHS Elements Covered:

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

EHS organization and staffing :

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

Air Emissions, Wastewater Management, Waste Management, Spill Prevention :

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

Risk Assessment and Controls:

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

General Safety and Controls:

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

Process Safety:

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

Life Safety and Emergency Response:

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

Evaluation Criteria:

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

Audit Process followed:

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

Most Common Observations-Environment :

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

Most Common Observations-Process safety and personal safety :

Most C ommon 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

Most Common Observations-Industrial Hygiene :

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

Outcome:

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

Lessons Learned:

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

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