EHS in Pharmaceutical Manufacturing Lecture 1

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Questions and Answers

What is one of the primary aims of the course PHEN 504?

To produce new pharmaceuticals

To assess environmental risks in pharmaceuticals (correct)

To study consumer behavior in pharma

To reduce manufacturing costs

Why is EHS considered important in pharmaceutical manufacturing?

It ensures product safety and prevents contamination (correct)

It enhances brand reputation

It increases product marketing

It minimizes worker salaries

Which of the following is a key element of EHS Management Systems?

Cost reduction methods

Compliance with regulations (correct)

Marketing strategies

Employee productivity

What is one of the learning outcomes expected from the course?

Understanding of key regulations in EHS Signup and view all the answers

What is a significant consequence of failing to implement EHS in pharmaceuticals?

Higher product recall rates Signup and view all the answers

Which of the following best practices is emphasized for EHS in pharmaceutical manufacturing?

Environmental risk assessments Signup and view all the answers

Which type of assessment is essential for identifying potential environmental impacts in pharmaceuticals?

Environmental risk assessment Signup and view all the answers

What is the future outlook for EHS in the pharmaceutical industry?

Increased regulation and focus on sustainability Signup and view all the answers

What does EHS primarily focus on within organizations?

Identifying and assessing risks, and ensuring compliance Signup and view all the answers

Which regulatory agency is responsible for ensuring drug safety?

Food and Drug Administration (FDA) Signup and view all the answers

Why is EHS considered important in the pharmaceutical industry?

It prevents accidents and promotes sustainable practices. Signup and view all the answers

Which aspect is NOT typically included in EHS practices?

Assessing market demand Signup and view all the answers

What is a key focus of the Environmental Protection Agency (EPA)?

Minimizing air, water, and soil contamination Signup and view all the answers

Which of the following represents a significant consideration in worker health and safety within pharma?

Chemical and biological hazard identification Signup and view all the answers

Which of these is a purpose of implementing Good Manufacturing Practices (GMP) in relation to EHS?

Ensuring safety and minimizing environmental impact Signup and view all the answers

What is the primary concern of the World Health Organization (WHO) in relation to pharmaceuticals?

Harmonizing international pharmaceutical practices Signup and view all the answers

What does EHS stand for in the context of pharmaceutical manufacturing?

Environment, Health, and Safety Signup and view all the answers

What is the primary goal of EHS in pharmaceutical manufacturing?

Minimizing workplace hazards Signup and view all the answers

Which of the following is a focus area covered in Week 8 of the course?

Occupational Health and Safety Risk Assessment Signup and view all the answers

What does CAPA stand for in the context of preventing contamination?

Corrective and Preventive Actions Signup and view all the answers

What health risk was associated with the drug phenylpropanolamine (PPA)?

Increased risk of bleeding in the brain Signup and view all the answers

Which percentage of the total student assessment is allocated to the final exam?

40% Signup and view all the answers

What role do key regulatory agencies play in EHS?

They establish guidelines and regulations for safety practices. Signup and view all the answers

What is a primary goal of Continuous Improvement (CI) in EHS practices?

To reduce contamination incidents over time Signup and view all the answers

What is the primary role of the Egyptian Environmental Affairs Agency (EEAA)?

Preparation of environmental prevention studies Signup and view all the answers

In the context of EHS, why is the link between environmental protection and public health significant?

It helps prevent future health crises. Signup and view all the answers

Which medication was recalled due to EHS issues related to health risks?

Sibutramine (Meridia) Signup and view all the answers

Which committee was the individual a Deputy Chairman of from 2015 to 2016?

Higher Education Reform Experts committee (HEREs) Signup and view all the answers

What is one of the key functions of environmental health and safety (EHS) in pharmaceuticals?

To investigate contamination sources and manage risks Signup and view all the answers

Which topic is NOT covered in the first half of the course?

Regulatory Compliance and Auditing Signup and view all the answers

What is the duration of office hours for the course instructor?

Thursday 11:00 am - 1:00 pm Signup and view all the answers

Which of the following roles did the individual hold from 2008 to 2013?

Director of Industrial Environmental Impact Assessment Department Signup and view all the answers

Which agency certified the individual as an auditor for Occupational Safety and Health Standards?

Occupational Safety and Health Administration (OSHA) Signup and view all the answers

When did the individual become a member of the JICA Alumin Association?

2007 Signup and view all the answers

In what capacity did the individual serve at Beni-Suef University (BSU)?

Associate Professor and consultant for EIA Signup and view all the answers

What was one of the roles the individual held from 2006 to 2008?

Deputy Manager of Solid Waste Department Signup and view all the answers

Which project was the individual involved in under the GEF-WB?

Sustainable Persistent Organic Pollutants Management Project Signup and view all the answers

Study Notes

### Course Details

This course covers the importance of Environmental, Health, and Safety (EHS) in pharmaceutical manufacturing.
The course spans 12 weeks, with one lecture per week.
The course is assessed through a final exam, midterm exam, quizzes, projects, and assignments each contributing to a percentage of the overall grade.
The instructor is Dr. Asmaa Hamouda, and Eng. Donia serves as the Teaching Assistant (TA).

Lecture 1 Objectives
Understand the importance of EHS in pharmaceutical manufacturing.
Learn about key regulatory agencies involved in pharmaceutical EHS.
Explore the relationship between environmental protection, worker safety, and public health.

What is EHS?

EHS stands for Environmental, Health, and Safety.
EHS aims to protect human health and safety by minimizing hazards in the workplace, environment, and communities.
EHS professionals work to prevent accidents, injuries, and illnesses, as well as address environmental concerns like pollution and waste management.
EHS encompasses various aspects including identifying and assessing risks, implementing safety measures and protocols, ensuring compliance with regulations, and promoting a culture of safety.

Why is EHS Important in Pharma?

Ensures compliance with legal and regulatory standards.
Prevents accidents, injuries, and environmental damage, promoting a safe working environment.
Promotes sustainable and ethical manufacturing practices.

Key Regulations in EHS

Major regulatory agencies include:
- OSHA: Occupational Safety and Health Administration (focuses on occupational safety and hazardous materials).
- EPA: Environmental Protection Agency (focuses on environmental protection and pollution control).
- FDA: Food and Drug Administration (ensures drug safety, contamination control, and GMP compliance).
- WHO: World Health Organization (provides international guidelines and harmonization).
Regulatory agencies significantly impact pharmaceutical manufacturing practices.
EHS plays a crucial role in Good Manufacturing Practices (GMP) compliance.

Environmental Protection in Pharma

Pharmaceutical manufacturing strives to minimize contamination of air, water, and soil.
Proper waste management is essential for environmental protection.
Clean technologies and sound environmental policies are critical.

Worker Health and Safety

Protecting worker health is paramount in pharmaceutical settings.
Hazard identification is crucial, including chemical, biological, and ergonomic risks.
Safety protocols are vital, such as personal protective equipment (PPE), air quality controls, and ergonomic equipment.

Role of EHS in Preventing Contamination and Ensuring Product Safety

EHS plays a significant role in preventing contamination and ensuring product safety.
EHS helps to ensure the quality, effectiveness, and safety of pharmaceutical products.
EHS principles are crucial in preventing product recalls due to contamination or safety issues.

Examples of Drug Recalls due to EHS Issues

Drug recalls can occur due to safety concerns, including contamination or side effects.
Phenylpropanolamine (PPA), used in some decongestants and weight loss medications, was recalled in 2000 due to its association with increased hemorrhagic stroke risk.
Sibutramine (Meridia), a weight loss drug, was recalled from the United States due to concerns about its cardiovascular risks.

Instructor Profile

Dr. Asmaa Hamouda, Associate Professor of Chemical and Environmental Engineering at Beni-Suef University (BSU), has extensive experience in various aspects of EHS management.
Dr. Hamouda holds a Ph.D. in Integrated Hazardous Waste Management, focusing on PCBs, as well as degrees in Environmental Planning and Industrial Wastewater Treatment.
Dr. Hamouda has worked as an environmental consultant and held leadership roles in the Egyptian Environmental Affairs Agency (EEAA).
Dr. Hamouda has been involved in various professional organizations and committees related to EHS and sustainability.
Her expertise includes environmental impact assessment (EIA), pollution control, and waste management.

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Description

This quiz focuses on the first lecture of the Environmental, Health, and Safety (EHS) course in pharmaceutical manufacturing. It covers the significance of EHS, key regulatory agencies, and the relationship between environmental protection, worker safety, and public health. Test your understanding of the foundational concepts introduced in this course.