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Due Diligence Audits

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Title: Due Diligence Audits


1
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 Internationa
l Safety Systems, Inc. (ISS), India
2
AGENDA
  • Pharmaceutical growth in India
  • EHS status at Contract Manufacturing sites
  • EHS audit objectives and methods
  • Observations
  • Outcomes
  • Lessons Learned

3
EVOLUTION OF INDIAN PHARMA INDUSTRY
4
India Major focus for Contract Manufacturing
  • According to a study in 2013, India is
  • 4th in the world in terms of production volumes
  • 13th 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

5
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

6
EHS Audits
  • Due Diligence audits for
  • Potential suppliers
  • With QA/QC Team
  • EHS Assessments for
  • Existing Suppliers
  • API Manufacturing sites
  • Formulation sites
  • Vaccine plant

7
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)

8
EHS Audits Conducted
  • Germany
  • Leverkusen
  • Dessau-Wörlitz
  • Ireland
  • Arklow
  • France
  • Calais
  • Spain
  • Barcelona
  • Ukrain
  • Hungary (Budapest)

9
EHS Audits Conducted
  • USA
  • Rancho Cordova, CA
  • North Bend, LA
  • Hickok, KS
  • Canada
  • Hamilton
  • Brazil (two sites)

10
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

11
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

12
EHS organization and staffing
  • EHS Staffing and Competencies
  • Health, Safety, Environment Policy
  • Safety committees
  • Accidents reporting and investigation
  • Training matrices and training conducted

13
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

14
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

15
General Safety and Controls
  • Job Safety Analysis
  • Permit Systems
  • Fall Protection
  • Machine Guarding
  • Electrical safety and energy isolation procedures
  • Housekeeping

16
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

17
Life Safety and Emergency Response
  • Means of egress
  • Fire Protection Systems and Alarms
  • Written Plans
  • Evacuation Procedures

18
Evaluation Criteria
  • Parent company specific guidelines
  • Local regulations
  • National and international standards
  • Best Practices in pharmaceutical industries

19
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

20
Most Common Observations-Environment
  • Regulatory
  • Environment Consent Requirements (quantity of
    waste generated, disposed off)
  • Non-regulatory
  • Determining presence of API in Waste

21
Most Common 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

22
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

23
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

24
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

25
Thank You Questions??
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