This document summarizes lessons learned from conducting environmental, health, and safety audits at pharmaceutical contract manufacturing sites in India. The audits assessed compliance with regulations and industry best practices. Common observations included a lack of nitrogen inerting validation, inadequate exposure assessments, and reliance on respiratory protection without robust programs. Sites were receptive to findings and addressed some issues immediately. The audits increased awareness of important issues like industrial hygiene and process safety. Conducting thorough on-site assessments and receiving feedback before reporting were valuable lessons learned.
Exposure Risk Assessment Challenges : Occupational Hygiene in the Pharmaceutical and Chemical Industries, AIHA 2013, Asia Pacific OH Conference, Singapore
5 Predictions for the Medical Device Industry in 2018 (and how you can prepare)Greenlight Guru
What should the medical device industry expect in 2018?
Great question.
From ISO 13485 being revised in 2016, the EU MDR / IVDR being revised in 2017, and the MDSAP program going live in 2017, regulatory changes have been rampant and significant for medical device professionals.
This presentation covers:
- Why you should expect it to be harder for devices to get to market and stay there in the EU
- How to avoid the mad dash to update ISO 13485 certification before the deadline
- Where the latest revision of ISO 14971 is and when to expect the next update
- About Health Canada and their MDSAP deadline
- Why companies are shifting from being compliance-focused to quality-focused
Watch the presentation, commentated by Greenlight Guru's founder Jon Speer, here: https://www.greenlight.guru/webinar/2018-medical-device-industry-predictions
How to Prepare for the New EU In Vitro Diagnostics RegulationsGreenlight Guru
Agreement was reached on the eagerly awaited new EU In Vitro Diagnostic Regulations (IVDR) earlier this year.
The IVDR will significantly change the way IVDs bear the CE mark, and it will include a completely new risk-based classification system.
Now 80% of all IVDs will need to be certified by a notified body under the IVDR where as before, only 20% needed to under the IVD Directive.
The new IVDR is expected to be formally published in late 2016 or early 2017, and there will be a five-year transition period to be compliant.
Many forward thinking IVD companies are already developing their plans for compliance now to gain strategic advantages over their competitors.
This presentation includes:
-Why the European regulations are changing
-What does the new regulation mean for IVD manufactures
-How to classify your IVD using the new risk-based classification system
-How to evaluate your existing clinical evidence to know if new studies will be needed to support your CE mark
-An overview of all the most significant changes brought by the IVDR
-What IVD manufactures can do to start preparing now
Watch the presentation here: https://www.greenlight.guru/webinar/eu-in-vitro-diagnostic-regulations-ivdr
Everyday Lessons from Extraordinary Circumstances.
The business decisions we make often have unforeseen, far-reaching effects wholly unrelated to its original intent.
Computational Modeling & Simulation in Orthopedics: Tools to Comply in an Ev...April Bright
Computational Modeling & Simulation has the ability to revolutionize the orthopedic device industry by reducing and in some instances eliminating the need for benchtop testing and clinical trials. Dr. Afshari shared his experience in establishing the credibility of computational models for product design and development purposes, and highlighted was that modeling fits with the regulatory and standards framework.
Systems-Based Leadership Approach (SBLA) to Human Error in Pharmaceutical Man...Ashley Turner
Human error in the pharmaceutical industry results in costly rework, lost product, and lost time to more drastic consequences that increase the risk to patients, consumers, employees, and operations. Human error reduction methods and risk management techniques are highly sought after and utilized to optimize operations, increase profits, and minimize safety hazards. This presentation distinguishes human error reduction from a person-centered and a systems-based approach in the pharmaceutical industry. The research constructs a theoretical framework of a novel approach from literature research and information gained through interviews with subject matter experts. Furthermore, the research focuses on managerial implications with this new approach and emphasizes the importance of leadership’s involvement through the Bhopal Disaster, which was the world’s worst industrial accident.
Exposure Risk Assessment Challenges : Occupational Hygiene in the Pharmaceutical and Chemical Industries, AIHA 2013, Asia Pacific OH Conference, Singapore
5 Predictions for the Medical Device Industry in 2018 (and how you can prepare)Greenlight Guru
What should the medical device industry expect in 2018?
Great question.
From ISO 13485 being revised in 2016, the EU MDR / IVDR being revised in 2017, and the MDSAP program going live in 2017, regulatory changes have been rampant and significant for medical device professionals.
This presentation covers:
- Why you should expect it to be harder for devices to get to market and stay there in the EU
- How to avoid the mad dash to update ISO 13485 certification before the deadline
- Where the latest revision of ISO 14971 is and when to expect the next update
- About Health Canada and their MDSAP deadline
- Why companies are shifting from being compliance-focused to quality-focused
Watch the presentation, commentated by Greenlight Guru's founder Jon Speer, here: https://www.greenlight.guru/webinar/2018-medical-device-industry-predictions
How to Prepare for the New EU In Vitro Diagnostics RegulationsGreenlight Guru
Agreement was reached on the eagerly awaited new EU In Vitro Diagnostic Regulations (IVDR) earlier this year.
The IVDR will significantly change the way IVDs bear the CE mark, and it will include a completely new risk-based classification system.
Now 80% of all IVDs will need to be certified by a notified body under the IVDR where as before, only 20% needed to under the IVD Directive.
The new IVDR is expected to be formally published in late 2016 or early 2017, and there will be a five-year transition period to be compliant.
Many forward thinking IVD companies are already developing their plans for compliance now to gain strategic advantages over their competitors.
This presentation includes:
-Why the European regulations are changing
-What does the new regulation mean for IVD manufactures
-How to classify your IVD using the new risk-based classification system
-How to evaluate your existing clinical evidence to know if new studies will be needed to support your CE mark
-An overview of all the most significant changes brought by the IVDR
-What IVD manufactures can do to start preparing now
Watch the presentation here: https://www.greenlight.guru/webinar/eu-in-vitro-diagnostic-regulations-ivdr
Everyday Lessons from Extraordinary Circumstances.
The business decisions we make often have unforeseen, far-reaching effects wholly unrelated to its original intent.
Computational Modeling & Simulation in Orthopedics: Tools to Comply in an Ev...April Bright
Computational Modeling & Simulation has the ability to revolutionize the orthopedic device industry by reducing and in some instances eliminating the need for benchtop testing and clinical trials. Dr. Afshari shared his experience in establishing the credibility of computational models for product design and development purposes, and highlighted was that modeling fits with the regulatory and standards framework.
Systems-Based Leadership Approach (SBLA) to Human Error in Pharmaceutical Man...Ashley Turner
Human error in the pharmaceutical industry results in costly rework, lost product, and lost time to more drastic consequences that increase the risk to patients, consumers, employees, and operations. Human error reduction methods and risk management techniques are highly sought after and utilized to optimize operations, increase profits, and minimize safety hazards. This presentation distinguishes human error reduction from a person-centered and a systems-based approach in the pharmaceutical industry. The research constructs a theoretical framework of a novel approach from literature research and information gained through interviews with subject matter experts. Furthermore, the research focuses on managerial implications with this new approach and emphasizes the importance of leadership’s involvement through the Bhopal Disaster, which was the world’s worst industrial accident.
A real-world introduction to PSM’s 14 Elements360factors
A number of recent incidents in various parts of the world have highlighted the increasing importance of effective Process Safety Management (PSM). This webinar presents a high-level overview of OSHA’s PSM requirements as well as real-world examples of how companies handle compliance.
Objectives
• Describe some of the major catastrophes which led to the formulation of PSM regulations.
• Introduce the 14 Elements of PSM.
• Present examples of various implementation approaches.
Range of management consultancy services provided by Matrix Management Systems for the following topics:
Management Systems
Policies
Risk Management
Regulatory Requirements, Standards and Compliance
Objectives and Targets
Strategies, Plans and Programmes
Organisation and People
Communications
Operational Control
Project Management
Data and Document Management
Management of Contractors
Management of Change (MoC)
Emergency Response
Monitoring, Analysis and Reporting
Incidents, Non-Conformances and Actions
Assurance and Audit
Performance Reviews and improvement
Knowledge management
Safety and environmental Case
I am looking for stable job with long term relation ship. I am ready to relocate within Gujarat. At present, I ERP manager in one of the EOU Gujarat based company. I am able to coordinate the ERP related activities. I can evaluate the ERP product and implementation partner considering various factors like multi company, multi location, multi currency, company's processes, turnover, strength etc.
This presentation by Morris Kleiner (University of Minnesota), was made during the discussion “Competition and Regulation in Professions and Occupations” held at the Working Party No. 2 on Competition and Regulation on 10 June 2024. More papers and presentations on the topic can be found out at oe.cd/crps.
This presentation was uploaded with the author’s consent.
Acorn Recovery: Restore IT infra within minutesIP ServerOne
Introducing Acorn Recovery as a Service, a simple, fast, and secure managed disaster recovery (DRaaS) by IP ServerOne. A DR solution that helps restore your IT infra within minutes.
0x01 - Newton's Third Law: Static vs. Dynamic AbusersOWASP Beja
f you offer a service on the web, odds are that someone will abuse it. Be it an API, a SaaS, a PaaS, or even a static website, someone somewhere will try to figure out a way to use it to their own needs. In this talk we'll compare measures that are effective against static attackers and how to battle a dynamic attacker who adapts to your counter-measures.
About the Speaker
===============
Diogo Sousa, Engineering Manager @ Canonical
An opinionated individual with an interest in cryptography and its intersection with secure software development.
Have you ever wondered how search works while visiting an e-commerce site, internal website, or searching through other types of online resources? Look no further than this informative session on the ways that taxonomies help end-users navigate the internet! Hear from taxonomists and other information professionals who have first-hand experience creating and working with taxonomies that aid in navigation, search, and discovery across a range of disciplines.
Sharpen existing tools or get a new toolbox? Contemporary cluster initiatives...Orkestra
UIIN Conference, Madrid, 27-29 May 2024
James Wilson, Orkestra and Deusto Business School
Emily Wise, Lund University
Madeline Smith, The Glasgow School of Art
Sharpen existing tools or get a new toolbox? Contemporary cluster initiatives...
Due Diligence Audits
1. www.issehs.com
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
International 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
www.issehs.com
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
www.issehs.com
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
www.issehs.com
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
www.issehs.com
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)
www.issehs.com
8. EHS Audits Conducted
Germany
– Leverkusen
– Dessau-Wörlitz
Ireland
– Arklow
France
– Calais
Spain
– Barcelona
Ukrain
Hungary (Budapest)
www.issehs.com
9. EHS Audits Conducted
USA
– Rancho Cordova, CA
– North Bend, LA
– Hickok, KS
Canada
– Hamilton
Brazil (two sites)
www.issehs.com
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
www.issehs.com
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
www.issehs.com
12. EHS organization and staffing
EHS Staffing and Competencies
Health, Safety, Environment Policy
Safety committees
Accidents reporting and investigation
Training matrices and training conducted
www.issehs.com
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
www.issehs.com
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
www.issehs.com
15. General Safety and Controls
Job Safety Analysis
Permit Systems
Fall Protection
Machine Guarding
Electrical safety and energy isolation procedures
Housekeeping
www.issehs.com
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
www.issehs.com
17. Life Safety and Emergency
Response
Means of egress
Fire Protection Systems and Alarms
Written Plans
Evacuation Procedures
www.issehs.com
18. Evaluation Criteria
Parent company specific guidelines
Local regulations
National and international standards
Best Practices in pharmaceutical industries
www.issehs.com
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
www.issehs.com
20. Most Common Observations-
Environment
Regulatory
– Environment Consent Requirements (quantity
of waste generated, disposed off)
Non-regulatory
– Determining presence of API in Waste
www.issehs.com
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
www.issehs.com
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
www.issehs.com
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
www.issehs.com
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
www.issehs.com
India has over 550 manufacturing sites registered with the US Food and Drug Administration, of which 323 are USFDA approved, as on March 2013, says the Indian Commerce Ministry, citing Pharmaceuticals Export Promotion Council of India (Pharmexcil) data. And there are 350 manufacturing sites endorsed by the European Union for their Good Manufacturing Practices in India, as on April 2013, it added.
The EHS Assessments (audits) are mostly conducted along with the QA/QC teams for potential suppliers. The assessments were also carried out for existing suppliers for APIs and formulations including vaccine mfg. plants. Formulations include tablets (coated, uncoated), capsules, liquid orals, ointments, gels