www.issehs.com EHS Auditing in Pharmaceutical Supply Chain – Lessons Learned Pharma Forum 2016 AIHCE, Baltimore May 25 Prasanth K. CIH Pinky Bhatt, CIH Maharshi Mehta, CSP, CIH International Safety Systems, Inc. Washingtonville, New York
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EHS Auditing in Pharmaceutical
Supply Chain – Lessons Learned
Pharma Forum 2016
AIHCE, Baltimore May 25
Prasanth K. CIH
Pinky Bhatt, CIH
Maharshi Mehta, CSP, CIH
International Safety Systems, Inc.
Washingtonville, New York
Agenda
Scope
Audits conducted
Locations
Lessons learned
Audit trends and ISS perspective in India and
China
Audit trends and paradigm shift globally
PSCI Interventions
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Scope
Regulatory Compliance
– Environmental
– Process Safety
– Occupational Safety
– Industrial Hygiene
Additional Pharmaceutical Supply Chain
Initiatives (PSCI) principles
– Social responsibility
– Forced labour
– Wages/overtime
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PSCI
Group of leading multinational pharmaceutical
companies for promoting supply chain
management and healthy business conditions.
Vision – Better, Social, Environment and
economic outcome from communities in supply
chain.
Significant contribution
– Educational materials
– Capacity building
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Projects: Pharmaceutical Supplier
Site EHS and PSCI Audits
49 sites
– 10 sites of one pharma corporation in 2001
– 39 sites of another two pharma corporation between
2011 and 2015
Two, three-day training workshops for suppliers
– 2001 – most rewarding experience
– 2015 – in Mumbai
Cohosted PSCI training and presenting on PSM, Safety
and regulations
24/7 support
Post audit assistance visits at 10 sites
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Our auditing approach
Strong business ethics and integrity
Less in office and more on site
Comprehensive
Two level of reviews
Firm and flexible
Listen and verify
Cost effective
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Pharma Supply Chain Audits 2011-
2015: 85 % from Emerging economies
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Trends-Lessons Learned
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Observations - Total: 578
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Regulatory
Safety/Process Safety
– Energy Isolation
– Permits are not present for excavation
– Flammable Liquid Storage License
Industrial Hygiene
– Exposure Assessment
Environment
– Permit
– Annual returns on environmental compliance not
filed/filed after due date
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Non regulatory Observations:
Total 375+
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PSM/Fire Protection
No flame arrestor breather valves on flammable liquid
storage tank vents, Vent closed with plastic bag
Inerting not done – or not validated
None or inefficient static electricity protection
No fire protection
Water pressure less than 7 Bar
HDPE pipe as fire hydrant
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PSM
Manual charging of 16 kg sodium azide in reactor
containing solvents
Rotameter not available – operator presence needed for
N2 purging of reactor
Toluene dispensing into 5 L HDPE container and manual
charging
All wooden doors at API plant entrance/exit
Fire water house connected to municipal water supply –
ware house – No sprinkler
Normal forklift in flammable liquid handling area
NaOH and Solvent storage tanks in same dyke
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Environmental
Permit specified parameters not monitored (incorrect
location)
Permit specified parameters exceeding limit
(Sludge/Used oil/Ambient Noise)
Water used as scrubbing media for VOC
Waste sent to unauthorized vendor/ No records of ETP
sludge disposal
No determination on quantity of API in solid and
treated waste water discharge
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IH
No or minimal hazard communication
No risk assessments or written program
Reliability of exposure monitoring data
No exposure controls or hierarchy of controls
not followed
OEB 4 API exposure potential
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IH
Reusable gown and no disposable Tyvek with OEB
4 compound
Latex gloves with skin sensitizer
Same room for gowning and de-gowning.
No respiratory protection program
– Selection
– Storage
– Use
– Decontamination
General medical surveillance and not substance
specific
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Potential impact
Loss of life, impact on health
Community impact
Supplier and parent company image-reputation
risk
Supply interruption
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Lessons Learned
Environment/Social: Better
Safety – Good
PSM/IH – serious concerns
Knowledge gap-strong desire to learn and
improve
Low hanging fruits and then refining
Cost a major concern
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Capacity Building
First supplier training for a pharma
corporation
– Conducted in 2001
– 70 participants
– Basics of EHS – easy to understand
– Workshop – list of observations and
recommendations
Three-day workshop in 2015
– ISS and Corporate faculties
– Based on high priority audit
findings
Webinars
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PSCI – ISS – training workshop
for Supply Chain sites in India
175 participants
Two papers presented on
Fundamentals of Process
Safety Management
Environmental Law
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Contribution from Corporate
and Plant IHs
Interact with auditors and identify priority
observations
Provide support on high priority items
– IH and PSM
Assist in capacity building
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Acknowledgement
Pinky for compiling all reports, preparing excel
file of observations and listing high priority
observations
Lili who supported Pinky
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