pharma forum 2016 ehs audits lessons learnt by prashanth k

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EHS Auditing in Pharmaceutical EHS Auditing in Pharmaceutical Supply Chain – Lessons LearnedSupply Chain – Lessons Learned

Pharma Forum 2016AIHCE, Baltimore May 25

Prasanth K. CIHPinky Bhatt, CIHMaharshi Mehta, CSP, CIHInternational Safety Systems, Inc. Washingtonville, New York

AgendaAgenda

Scope Audits conducted Locations Lessons learned Audit trends and ISS perspective in India and

China Audit trends and paradigm shift globally PSCI Interventions


ScopeScope

Regulatory ComplianceRegulatory Compliance– EnvironmentalEnvironmental– Process SafetyProcess Safety– Occupational Safety Occupational Safety – Industrial HygieneIndustrial Hygiene

Additional Pharmaceutical Supply Chain Initiatives Additional Pharmaceutical Supply Chain Initiatives (PSCI) principles(PSCI) principles– Social responsibilitySocial responsibility– Forced labourForced labour– Wages/overtime Wages/overtime


PSCI PSCI

Group of leading multinational pharmaceutical Group of leading multinational pharmaceutical companies for promoting supply chain companies for promoting supply chain management and healthy business conditions.management and healthy business conditions.

Vision – Better, Social, Environment and Vision – Better, Social, Environment and economic outcome from communities in supply economic outcome from communities in supply chain.chain.

Significant contribution Significant contribution – Educational materialsEducational materials– Capacity building Capacity building


Projects: Pharmaceutical Supplier Projects: Pharmaceutical Supplier Site EHS and PSCI AuditsSite EHS and PSCI Audits

49 sites 49 sites – 10 sites of one pharma corporation in 200110 sites of one pharma corporation in 2001– 39 sites of another two pharma corporation between 2011 and 39 sites of another two pharma corporation between 2011 and

20152015 Two, three-day training workshops for suppliersTwo, three-day training workshops for suppliers

– 2001 – most rewarding experience 2001 – most rewarding experience – 2015 – in Mumbai 2015 – in Mumbai

Cohosted PSCI training and presenting on PSM, Safety and regulationsCohosted PSCI training and presenting on PSM, Safety and regulations 24/7 support24/7 support Post audit assistance visits at 10 sites Post audit assistance visits at 10 sites


Our auditing approachOur auditing approach

Strong business ethics and integrity Strong business ethics and integrity Less in office and more on siteLess in office and more on site ComprehensiveComprehensive Two level of reviewsTwo level of reviews Firm and flexibleFirm and flexible Listen and verify Listen and verify Cost effectiveCost effective


Pharma Supply Chain Audits 2011-Pharma Supply Chain Audits 2011-2015:2015: 85 % from Emerging economies85 % from Emerging economies


Trends-Lessons LearnedTrends-Lessons Learned


Observations - Total: 578Observations - Total: 578


Regulatory Regulatory Safety/Process Safety Safety/Process Safety

– Energy IsolationEnergy Isolation– Permits are not present for excavationPermits are not present for excavation– Flammable Liquid Storage LicenseFlammable Liquid Storage License

Industrial HygieneIndustrial Hygiene– Exposure Assessment Exposure Assessment

Environment Environment – Permit Permit – Annual returns on environmental compliance not filed/filed Annual returns on environmental compliance not filed/filed

after due dateafter due date


Non regulatory Observations: Non regulatory Observations: Total 375+ Total 375+


PSM/Fire ProtectionPSM/Fire Protection

No flame arrestor breather valves on flammable liquid No flame arrestor breather valves on flammable liquid storage tank vents, Vent closed with plastic bagstorage tank vents, Vent closed with plastic bag

Inerting not done – or not validatedInerting not done – or not validated None or inefficient static electricity protection None or inefficient static electricity protection No fire protection No fire protection Water pressure less than 7 BarWater pressure less than 7 Bar HDPE pipe as fire hydrant HDPE pipe as fire hydrant


PSMPSM

Manual charging of 16 kg sodium azide in reactor containing Manual charging of 16 kg sodium azide in reactor containing solventssolvents

Rotameter not available – operator presence needed for N2 Rotameter not available – operator presence needed for N2 purging of reactor purging of reactor

Toluene dispensing into 5 L HDPE container and manual Toluene dispensing into 5 L HDPE container and manual chargingcharging

All wooden doors at API plant entrance/exitAll wooden doors at API plant entrance/exit Fire water house connected to municipal water supply – ware Fire water house connected to municipal water supply – ware

house – No sprinklerhouse – No sprinkler Normal forklift in flammable liquid handling area Normal forklift in flammable liquid handling area NaOH and Solvent storage tanks in same dykeNaOH and Solvent storage tanks in same dyke


EnvironmentalEnvironmental

Permit specified parameters not monitored (incorrect Permit specified parameters not monitored (incorrect location)location)

Permit specified parameters exceeding limit Permit specified parameters exceeding limit (Sludge/Used oil/Ambient Noise)(Sludge/Used oil/Ambient Noise)

Water used as scrubbing media for VOCWater used as scrubbing media for VOC Waste sent to unauthorized vendor/ No records of ETP Waste sent to unauthorized vendor/ No records of ETP

sludge disposalsludge disposal No determination on quantity of API in solid and treated No determination on quantity of API in solid and treated

waste water dischargewaste water discharge


IHIH

No or minimal hazard communicationNo or minimal hazard communication No risk assessments or written programNo risk assessments or written program Reliability of exposure monitoring dataReliability of exposure monitoring data No exposure controls or hierarchy of controls No exposure controls or hierarchy of controls

not followed not followed OEB 4 API exposure potential OEB 4 API exposure potential


IHIH Reusable gown and no disposable Tyvek with OEB 4 Reusable gown and no disposable Tyvek with OEB 4

compoundcompound Latex gloves with skin sensitizer Latex gloves with skin sensitizer Same room for gowning and de-gowning.Same room for gowning and de-gowning. No respiratory protection programNo respiratory protection program

– SelectionSelection– StorageStorage– UseUse– DecontaminationDecontamination

General medical surveillance and not substance specificGeneral medical surveillance and not substance specific


Potential impact Potential impact

Loss of life, impact on health Loss of life, impact on health Community impactCommunity impact Supplier and parent company image-reputation Supplier and parent company image-reputation

riskrisk Supply interruptionSupply interruption


Lessons LearnedLessons Learned

Environment/Social: BetterEnvironment/Social: Better Safety – Good Safety – Good PSM/IH – serious concernsPSM/IH – serious concerns Knowledge gap-strong desire to learn and Knowledge gap-strong desire to learn and

improve improve Low hanging fruits and then refiningLow hanging fruits and then refining Cost a major concern Cost a major concern


Capacity Building Capacity Building First supplier training for a pharma First supplier training for a pharma

corporation corporation – Conducted in 2001Conducted in 2001– 70 participants 70 participants – Basics of EHS – easy to understandBasics of EHS – easy to understand– Workshop – list of observations and Workshop – list of observations and

recommendations recommendations Three-day workshop in 2015Three-day workshop in 2015

– ISS and Corporate facultiesISS and Corporate faculties– Based on high priority audit findingsBased on high priority audit findings

Webinars Webinars


PSCI – ISS – training workshop PSCI – ISS – training workshop for Supply Chain sites in India for Supply Chain sites in India

175 participants175 participants

Two papers presented on

Fundamentals of Process Safety Management

Environmental Law


Contribution from Corporate Contribution from Corporate and Plant IHsand Plant IHs Interact with auditors and identify priority Interact with auditors and identify priority

observationsobservations Provide support on high priority items Provide support on high priority items

– IH and PSMIH and PSM Assist in capacity building Assist in capacity building


Acknowledgement Acknowledgement

Pinky for compiling all reports, preparing excel Pinky for compiling all reports, preparing excel file of observations and listing high priority file of observations and listing high priority observationsobservations

Lili who supported Pinky Lili who supported Pinky


pharma forum 2016 ehs audits lessons learnt by prashanth k

Presentations & Public Speaking