www.issehs.com Developing Sustainable EHS Developing Sustainable EHS Programs at Pharmaceutical Programs at Pharmaceutical Companies in Emerging Economies – Companies in Emerging Economies – India Experience India Experience Maharshi Mehta, CSP, CIH Maharshi Mehta, CSP, CIH Toral Mehta, CIH Toral Mehta, CIH International Safety Systems, Inc International Safety Systems, Inc USA-India-China-Mexico-Brazil USA-India-China-Mexico-Brazil www.issehs.com www.issehs.com 1- 1-1 Pharma Forum, 2010 Pharma Forum, 2010 AIHCE, Denver, May 26, 2010 AIHCE, Denver, May 26, 2010
Transcript
www.issehs.com
Developing Sustainable EHS Programs at Developing Sustainable EHS Programs at Pharmaceutical Companies in Emerging Pharmaceutical Companies in Emerging Economies – India ExperienceEconomies – India Experience
Maharshi Mehta, CSP, CIHMaharshi Mehta, CSP, CIH
Toral Mehta, CIHToral Mehta, CIH
International Safety Systems, IncInternational Safety Systems, Inc
AIHCE, Denver, May 26, 2010AIHCE, Denver, May 26, 2010
www.issehs.com
AgendaAgenda
Part 1:Part 1:– Introduction and backgroundIntroduction and background– Challenges in EHSChallenges in EHS– Approaches AdoptedApproaches Adopted– InstitutionsInstitutions– Regulatory FrameworkRegulatory Framework
Part 2:Part 2:– Case StudiesCase Studies– Supply Chain SiteSupply Chain Site– Pharma Corporation with manufacturing sitePharma Corporation with manufacturing site– Third Party Contract Manufacturers (TCM) Third Party Contract Manufacturers (TCM)
22
www.issehs.com
Basis for PresentationBasis for Presentation
EHS capacity building in pharma companies in Emerging EHS capacity building in pharma companies in Emerging EconomiesEconomies
Lessons learned from: Lessons learned from: – Conducting IH Process Safety Assessments at Pharma companies, Conducting IH Process Safety Assessments at Pharma companies,
supply chain and contract manufacturing sitessupply chain and contract manufacturing sites– Conducting > 5000 API Surrogate monitoringConducting > 5000 API Surrogate monitoring– Assisting in exposure control and program implementationAssisting in exposure control and program implementation– Developing Pharma Company specific training modules and Developing Pharma Company specific training modules and
conducting training for companies and Third Party Manufacturers conducting training for companies and Third Party Manufacturers (TPM). (TPM).
– Most importantly, from Corporate EHS leaders and EHS work Most importantly, from Corporate EHS leaders and EHS work conducted globallyconducted globally
33
www.issehs.com
IntroductionIntroduction
India ranks third in terms of manufacturing pharma products India ranks third in terms of manufacturing pharma products by volumeby volume
World’s largest producer of bulk drugsWorld’s largest producer of bulk drugs Worth $13B marketWorth $13B market ~ 10% annual growth~ 10% annual growth Supply chain, third party manufacturing increasing rapidlySupply chain, third party manufacturing increasing rapidly Outsourcing expected to exceed $53B in 2010Outsourcing expected to exceed $53B in 2010 Share of generic in US from Indian companies expected to Share of generic in US from Indian companies expected to
grow at 6% in 2011 from 2% in 2006grow at 6% in 2011 from 2% in 2006http://www.slideshare.net/workosaur/indian-pharma-industry-presentation-010709?http://www.slideshare.net/workosaur/indian-pharma-industry-presentation-010709?
from=share_emailfrom=share_email
44
www.issehs.com
Clusters of Pharma CompaniesClusters of Pharma Companies
55
Ahmedabad, Baroda, Ankleshwar
Hyderabad
Baddi, Chandigarh
Mumbai, Aurngabad Nasik
Goa
www.issehs.com
InfrastructureInfrastructure
Over 450 Over 450 colleges/departments offering colleges/departments offering degree and other education degree and other education programs in pharmaceutical programs in pharmaceutical sciencescience
More than 50,000 students More than 50,000 students graduates/yeargraduates/year
Two colleges offering Two colleges offering Master in Industrial Master in Industrial Hygiene ProgramHygiene Program
150 Industrial Hygienists 150 Industrial Hygienists for all companiesfor all companies
5 CIHs5 CIHs Safety professionals or Safety professionals or
occupational physicians occupational physicians practicing IHpracticing IH
No Accredited Lab for No Accredited Lab for API/SurrogateAPI/Surrogate 66
Pharma Manufacturing EHS
www.issehs.com
ChallengesChallenges
Limited Resources – IH professionalsLimited Resources – IH professionals QA in exposure assessment data QA in exposure assessment data Financial constrainsFinancial constrains
Manufacturing and outsourcing is increasing rapidly and Manufacturing and outsourcing is increasing rapidly and corporate EHS and other resources are decreasingcorporate EHS and other resources are decreasing
Trained corporate EHS professionals are unable to cop-up Trained corporate EHS professionals are unable to cop-up with demand for assistancewith demand for assistance
Distance, time differenceDistance, time difference Limited sensitivity of site professionals to potent compounds Limited sensitivity of site professionals to potent compounds
77
www.issehs.com
Approaches: Corporate and Approaches: Corporate and Regional EHS Regional EHS
Commendable effortsCommendable efforts AuditsAudits Regional training programs and meetingsRegional training programs and meetings Strong contract manufacturing programsStrong contract manufacturing programs Emphasis on selection of credible, competent Emphasis on selection of credible, competent
and cost-effective EHS service providersand cost-effective EHS service providers Providing limited financial supportProviding limited financial support
88
www.issehs.com
ApproachesApproaches
Education Programs in Industrial HygieneEducation Programs in Industrial Hygiene– University LevelUniversity Level– Pharma specific training modulesPharma specific training modules
never 1 samplenever 1 sample– Analytical cost discountsAnalytical cost discounts– Return on investment (e.g., savings from loss of API)Return on investment (e.g., savings from loss of API)– Not loosing focus on QANot loosing focus on QA
99
www.issehs.com
ApproachesApproaches
Empowering region and manufacturing sites in EHSEmpowering region and manufacturing sites in EHS TrainingTraining
– At the foundation of sustainable EHS programAt the foundation of sustainable EHS program
– Site specific, anecdotal , workshop at the siteSite specific, anecdotal , workshop at the site
– One corporation spends closed to $1B in all trainingOne corporation spends closed to $1B in all training
Qualitative Risk assessment and Control BandingQualitative Risk assessment and Control Banding– If exposure is obvious, why do monitoring?If exposure is obvious, why do monitoring?
– Exposure control and then monitoringExposure control and then monitoring
Surrogate MonitoringSurrogate Monitoring 7/24 support 7/24 support
Corporate requirement for supplier to demonstrate exposure is Corporate requirement for supplier to demonstrate exposure is below OEL through surrogate monitoringbelow OEL through surrogate monitoring
Corporate AuditCorporate Audit Local services provider to do hand-holding for some timeLocal services provider to do hand-holding for some time
– On site training on process safety and IHOn site training on process safety and IH
Limit number of suppliers based on EHS performance Limit number of suppliers based on EHS performance Shutting down operation when risk is imminent- provide Shutting down operation when risk is imminent- provide
limited assistance in reducing risklimited assistance in reducing risk
1111
www.issehs.com
Case Study 1 Case Study 1
Third Party Manufacturer (TPM)Third Party Manufacturer (TPM)
1212
www.issehs.com
Case Study 1: BackgroundCase Study 1: Background
Supplier of Bulk drug to Pharma CorporationSupplier of Bulk drug to Pharma Corporation Formaldehyde and other solvents usedFormaldehyde and other solvents used Open vessels, no inerting, high process safety riskOpen vessels, no inerting, high process safety risk Open formaldehyde handlingOpen formaldehyde handling Compressed air used for barrel transfer of chemicalsCompressed air used for barrel transfer of chemicals EHS expertise not available at site EHS expertise not available at site Local workforce with limited knowledge on process Local workforce with limited knowledge on process
safety and occupational hygienesafety and occupational hygiene
1313
Case Study 1: Approaches Case Study 1: Approaches AdoptedAdopted Corporate EHS professional conducted on-site Corporate EHS professional conducted on-site
reviewreview Shut down the operation with high process safety Shut down the operation with high process safety
and health riskand health risk TPM contacted usTPM contacted us Detailed review and exposure assessment Detailed review and exposure assessment
conducted, provided process and exposure controlsconducted, provided process and exposure controls– Enclosed vesselEnclosed vessel– Inerting specificationsInerting specifications– Grounding bonding, intrinsically safe lightingGrounding bonding, intrinsically safe lighting– LEV, PAPRsLEV, PAPRs
Re-evaluation of TPM site and facility started within Re-evaluation of TPM site and facility started within 3 months with significantly reduced risk3 months with significantly reduced risk
1414
www.issehs.com
Case Study 1: Training Case Study 1: Training
In consultation with Corporate EHS staff conducted training In consultation with Corporate EHS staff conducted training for all suppliers and TPMsfor all suppliers and TPMs
Risk specific manual developedRisk specific manual developed Conducted 3-day workshop on basics of process safety, Conducted 3-day workshop on basics of process safety,
personal safety and industrial hygiene for all CMs and personal safety and industrial hygiene for all CMs and supplierssuppliers
About 40 professionals from all TPM sites attendedAbout 40 professionals from all TPM sites attended Ongoing support to TPMsOngoing support to TPMs
1515
www.issehs.com
Case Study 2 Case Study 2
Corporation with Manufacturing in IndiaCorporation with Manufacturing in India
1616
www.issehs.com
Case Study 2: BackgroundCase Study 2: Background
High potent compound formulationsHigh potent compound formulations Effective containment for the most partEffective containment for the most part Limited TrainingLimited Training Previous exposure monitoring not Previous exposure monitoring not
conducted conducted Half face APR or mask usedHalf face APR or mask used
1717
Case Study 2: Approaches Case Study 2: Approaches AdoptedAdopted
Detailed Qualitative Exposure Assessment Detailed Qualitative Exposure Assessment Base line – limited Quantitative exposure Base line – limited Quantitative exposure
assessmentassessment Exposures identifiedExposures identified 7/24 support7/24 support Participation in monthly meetingParticipation in monthly meeting Recommendations:Recommendations:
– Work with equipment supplierWork with equipment supplier
– Additional exposure controls, e.g., LEV for Additional exposure controls, e.g., LEV for compression machine part cleaning compression machine part cleaning
– PAPRs in place of APRs PAPRs in place of APRs
– Employee work practices Employee work practices
1818
www.issehs.com
Case Study 2: Approaches Case Study 2: Approaches
Exposure AssessmentExposure Assessment– CIH and IH conducted periodical exposure assessments to identify CIH and IH conducted periodical exposure assessments to identify
continual improvementscontinual improvements– More than 400 API samples collected over a period of 4 years to identify More than 400 API samples collected over a period of 4 years to identify
continual improvements continual improvements – American Industrial Hygiene Association (AIHA) accredited laboratory American Industrial Hygiene Association (AIHA) accredited laboratory
in the USA analyzed samples in the USA analyzed samples – The facility demonstrated continual improvementsThe facility demonstrated continual improvements
TrainingTraining– Developed training manual with seven chaptersDeveloped training manual with seven chapters– Specific for APIs used and risk identifiedSpecific for APIs used and risk identified– Corporate EHS reviewed manual and provided inputCorporate EHS reviewed manual and provided input– Conducted on site training with workshopsConducted on site training with workshops
1919
www.issehs.com
Case Study 3 Case Study 3
Domestic Pharmaceutical CompanyDomestic Pharmaceutical Company
2020
www.issehs.com
Case Study 3: Background Case Study 3: Background
Supplier is one of the largest drug manufacturers Supplier is one of the largest drug manufacturers Pharma Corporation selected the supplierPharma Corporation selected the supplier Also, required the supplier to conduct surrogate Also, required the supplier to conduct surrogate
monitoring and demonstrate that exposure will be monitoring and demonstrate that exposure will be controlled when their drugs are madecontrolled when their drugs are made
Case Study 3: Approaches AdoptedCase Study 3: Approaches Adopted
Surrogate monitoringSurrogate monitoring– ISPE protocol followedISPE protocol followed
– Site specific protocol developedSite specific protocol developed
– Lactose usedLactose used
– More than 350 air and swab samples collectedMore than 350 air and swab samples collected
– Containment validation and cross contamination studies performed Containment validation and cross contamination studies performed simultaneouslysimultaneously
Organizations and InstitutionsOrganizations and Institutions
Organizations of Pharmaceutical Producers of India Organizations of Pharmaceutical Producers of India (OPPI) (OPPI) – http://www.indiaoppi.com/http://www.indiaoppi.com/– Key collaborator in EHSKey collaborator in EHS– We have offered two Workshops on Industrial Hygiene and SafetyWe have offered two Workshops on Industrial Hygiene and Safety
Indian Pharmaceutical Manufacturers AssociationIndian Pharmaceutical Manufacturers Association National Institute of Pharmaceutical Education and National Institute of Pharmaceutical Education and
Research in India (4 locations)Research in India (4 locations) National Pharmaceutical Pricing Authority fixing and National Pharmaceutical Pricing Authority fixing and
controlling prices of drugscontrolling prices of drugs
2323
www.issehs.com
Health and Safety Regulations Health and Safety Regulations
Director General Factory Advise and Service Labor Director General Factory Advise and Service Labor Institute (equivalent of NIOSH, HSE)Institute (equivalent of NIOSH, HSE)– http://dgfasli.nic.in/welcome.htmlhttp://dgfasli.nic.in/welcome.html
Indian Factories Act 1948 and subsequent amendmentsIndian Factories Act 1948 and subsequent amendments– http://dgfasli.nic.in/statutes5.htm
– Schedule 2 on Permissible exposure limitsSchedule 2 on Permissible exposure limits
State RulesState Rules Drugs and Pharmaceutical Industries covered under List Drugs and Pharmaceutical Industries covered under List
of Industries Involving Hazardous Processesof Industries Involving Hazardous Processes
2424
www.issehs.com
ConclusionsConclusions
Empower through effective training at regional and site Empower through effective training at regional and site levelslevels
Adopt cost effective approachesAdopt cost effective approaches Focus on qualitative exposure assessmentFocus on qualitative exposure assessment Focus on exposure controlsFocus on exposure controls Have strong control at design stage and surrogate Have strong control at design stage and surrogate
monitoring programmonitoring program Containment validation pre-requisite for TPMsContainment validation pre-requisite for TPMs Remain connected directly or through service providerRemain connected directly or through service provider
