Developing Sustainable EHS Programs at
Pharmaceutical Companies in Emerging
Economies – India Experience
Pharma Forum, 2010
AIHCE, Denver, May 26, 2010
Maharshi Mehta, CSP, CIH
Toral Mehta, CIH
International Safety Systems, Inc
USA-India-China-Mexico-Brazil
www.issehs.com
www.issehs.com
1-1
Agenda

Part 1:
–
–
–
–
–

Introduction and background
Challenges in EHS
Approaches Adopted
Institutions
Regulatory Framework
Part 2:
–
–
–
–
www.issehs.com
Case Studies
Supply Chain Site
Pharma Corporation with manufacturing site
Third Party Contract Manufacturers (TCM)
2
Basis for Presentation


EHS capacity building in pharma companies in
Emerging Economies
Lessons learned from:
– Conducting IH Process Safety Assessments at Pharma
companies, supply chain and contract manufacturing sites
– Conducting > 5000 API Surrogate monitoring
– Assisting in exposure control and program implementation
– Developing Pharma Company specific training modules and
conducting training for companies and Third Party
Manufacturers (TPM).
– Most importantly, from Corporate EHS leaders and EHS work
conducted globally
3
www.issehs.com
Introduction







India ranks third in terms of manufacturing pharma
products by volume
World’s largest producer of bulk drugs
Worth $13B market
~ 10% annual growth
Supply chain, third party manufacturing increasing
rapidly
Outsourcing expected to exceed $53B in 2010
Share of generic in US from Indian companies expected
to grow at 6% in 2011 from 2% in 2006
http://www.slideshare.net/workosaur/indian-pharma-industry-presentation010709?from=share_email
www.issehs.com
4
Clusters of Pharma Companies
Baddi,
Chandigarh
Ahmedabad,
Baroda,
Ankleshwar
Mumbai,
Aurngabad
Nasik
www.issehs.com
Hyderabad
5
Goa
Infrastructure




Pharma Manufacturing
Over 450
colleges/departments offering
degree and other education
programs in pharmaceutical
science
More than 50,000 students
graduates/year
Manufacturing equipment,
containment technologies
R&D centers , laboratories
www.issehs.com





EHS
Two colleges offering
Master in Industrial
Hygiene Program
150 Industrial Hygienists
for all companies
5 CIHs
Safety professionals or
occupational physicians
practicing IH
No Accredited Lab for
6
API/Surrogate
Challenges



Limited Resources – IH professionals
QA in exposure assessment data
Financial constrains
– Price Controls
– Competition




Manufacturing and outsourcing is increasing rapidly and
corporate EHS and other resources are decreasing
Trained corporate EHS professionals are unable to copup with demand for assistance
Distance, time difference
Limited sensitivity of site professionals to potent
compounds
www.issehs.com
7
Approaches: Corporate and
Regional EHS






Commendable efforts
Audits
Regional training programs and meetings
Strong contract manufacturing programs
Emphasis on selection of credible, competent
and cost-effective EHS service providers
Providing limited financial support
8
www.issehs.com
Approaches

Education Programs in Industrial Hygiene
– University Level
– Pharma specific training modules

Managing cost effectively
– Cost effective consulting
– Exposure assessment strategy – three samples
/HEG/API , never 1 sample
– Analytical cost discounts
– Return on investment (e.g., savings from loss of API)
– Not loosing focus on QA
www.issehs.com
9
Approaches


Empowering region and manufacturing sites in EHS
Training
– At the foundation of sustainable EHS program
– Site specific, anecdotal , workshop at the site
– One corporation spends closed to $1B in all training

Qualitative Risk assessment and Control Banding
– If exposure is obvious, why do monitoring?
– Exposure control and then monitoring


Surrogate Monitoring
7/24 support
10
www.issehs.com
Approaches – Supply Chain



Corporate requirement for supplier to demonstrate
exposure is below OEL through surrogate monitoring
Corporate Audit
Local services provider to do hand-holding for some
time
–
–
–
–


On site training on process safety and IH
Limited exposure assessment
Periodic supervision
7/24 support
Limit number of suppliers based on EHS performance
Shutting down operation when risk is imminent- provide
limited assistance in reducing risk
www.issehs.com
11
Case Study 1
Third Party Manufacturer (TPM)
12
www.issehs.com
Case Study 1: Background







Supplier of Bulk drug to Pharma Corporation
Formaldehyde and other solvents used
Open vessels, no inerting, high process safety risk
Open formaldehyde handling
Compressed air used for barrel transfer of chemicals
EHS expertise not available at site
Local workforce with limited knowledge on process
safety and occupational hygiene
13
www.issehs.com
Case Study 1: Approaches
Adopted Corporate EHS professional conducted on



site review
Shut down the operation with high process
safety and health risk
TPM contacted us
Detailed review and exposure assessment
conducted, provided process and exposure
controls
–
–
–
–

Enclosed vessel
Inerting specifications
Grounding bonding, intrinsically safe lighting
LEV, PAPRs
Re-evaluation of TPM site and facility
started within 3 months with significantly 14
reduced risk
Case Study 1: Training





In consultation with Corporate EHS staff conducted training
for all suppliers and TPMs
Risk specific manual developed
Conducted 3-day workshop on basics of process safety,
personal safety and industrial hygiene for all CMs and
suppliers
About 40 professionals from all TPM sites attended
Ongoing support to TPMs
15
www.issehs.com
Case Study 2
Corporation with Manufacturing in
India
16
www.issehs.com
Case Study 2: Background





High potent compound formulations
Effective containment for the most part
Limited Training
Previous exposure monitoring not
conducted
Half face APR or mask used
17
www.issehs.com
Case Study 2: Approaches
Adopted






Detailed Qualitative Exposure
Assessment
Base line – limited Quantitative
exposure assessment
Exposures identified
7/24 support
Participation in monthly meeting
Recommendations:
– Improve containment efficiencies
– Work with equipment supplier
– Additional exposure controls, e.g., LEV
for compression machine part cleaning
– PAPRs in place of APRs
– Employee work practices
18
Case Study 2: Approaches

Exposure Assessment
– CIH and IH conducted periodical exposure assessments to
identify continual improvements
– More than 400 API samples collected over a period of 4 years to
identify continual improvements
– American Industrial Hygiene Association (AIHA) accredited
laboratory in the USA analyzed samples
– The facility demonstrated continual improvements

Training
–
–
–
–
www.issehs.com
Developed training manual with seven chapters
Specific for APIs used and risk identified
Corporate EHS reviewed manual and provided input
Conducted on site training with workshops
19
Case Study 3
Domestic Pharmaceutical Company
20
www.issehs.com
Case Study 3: Background




Supplier is one of the largest drug manufacturers
Pharma Corporation selected the supplier
Also, required the supplier to conduct surrogate
monitoring and demonstrate that exposure will be
controlled when their drugs are made
Objectives
– Containment validation
– Identify cross contamination
– FDA risk assessment
21
www.issehs.com
Case Study 3: Approaches Adopted

Surrogate monitoring
–
–
–
–
–

ISPE protocol followed
Site specific protocol developed
Lactose used
More than 350 air and swab samples collected
Containment validation and cross contamination studies performed
simultaneously
Recommendations:
– Improved containment
– Engineering controls (LEV)
22
www.issehs.com
Organizations and Institutions

Organizations of Pharmaceutical Producers of India
(OPPI)
– http://www.indiaoppi.com/
– Key collaborator in EHS
– We have offered two Workshops on Industrial Hygiene and
Safety



Indian Pharmaceutical Manufacturers Association
National Institute of Pharmaceutical Education and
Research in India (4 locations)
National Pharmaceutical Pricing Authority fixing and
controlling prices of drugs
23
www.issehs.com
Health and Safety Regulations

Director General Factory Advise and Service Labor
Institute (equivalent of NIOSH, HSE)
– http://dgfasli.nic.in/welcome.html

Indian Factories Act 1948 and subsequent amendments
– http://dgfasli.nic.in/statutes5.htm
– Schedule 2 on Permissible exposure limits


State Rules
Drugs and Pharmaceutical Industries covered under List
of Industries Involving Hazardous Processes
24
www.issehs.com
Conclusions







Empower through effective training at regional and site
levels
Adopt cost effective approaches
Focus on qualitative exposure assessment
Focus on exposure controls
Have strong control at design stage and surrogate
monitoring program
Containment validation pre-requisite for TPMs
Remain connected directly or through service provider
25
www.issehs.com