Chemical hazards present major occupational health and safety risks in the pharmaceutical industry and can harm workers through skin contact, inhalation, ingestion, or injection. Common chemical hazards include neurotoxins, carcinogens, corrosives, and flammables. Proper management of chemical exposure involves guidelines for safety labeling, personal protective equipment, emergency response procedures, and monitoring exposure limits.
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Air Based Hazard, M.Pharm, Sem 2,Bhumi Suratiya, Pharmaceutical Quality Assurance. Source of air based hazard, types of air based hazard, air circulation maintenance for sterile and non sterile area . Application of air circulation, HEPA filter, clean area classification.
Air Based Hazards, M.pharm, sem 2,Bhumi Suratiya,.pptxBhumiSuratiya
Air Based Hazard, M.Pharm, Sem 2,Bhumi Suratiya, Pharmaceutical Quality Assurance. Source of air based hazard, types of air based hazard, air circulation maintenance for sterile and non sterile area . Application of air circulation, HEPA filter, clean area classification.
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TOPIC ~ Critical Hazard Management System
What Is Hazards ?
Why Management ?
The most common hazards
How to prevent workplace from Hazards
Identification of Hazards
Risk Assessment
Controlling risk and Hazards
Risk / Hazard monitoring
References.
Role of quality system and audits in pharmamaceuticalganpat420
Introduction
cGMP Regulations
Quality Assurance Function
Quality Systems Approach
Management Responsibilities
Resources
Manufacturing Operations
Evaluation Activities
Transitioning to Quality Systems Approach
Audit Checklist for Drug Industry
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By regulation, appropriate practice, and common sense, quality assurance (QA) is a critical function in the pharmaceutical manufacturing environment. The need for an independent unit to audit and comment on the appropriate application of standard operating procedures, master batch records, procedures approved in product applications, and the proper functioning of the quality control (QC) unit is paramount.
This helps assure that products are manufactured reliably, with adherence to approved specifications, and that current good manufacturing practices (cGMP) are maintained in conformance to regulation, both in the facility in general and the microenvironment of each product ’s manufacturing sequence.
This presentation describes outlines and discusses the regulations
applicable to the QA function and unit, structure, function and
application of the unit in the pharmaceutical manufacturing
environment. In addition, it discusses additional quality – related
responsibilities that may result when manufactures move toward a
quality system approach to quality that incorporates current quality
system models to further improve quality and harmonize with inter-
national quality requirements.
chemical Based Hazard, M.Pharm, Sem 2, Bhumi Suratiya, my presentation contains Regulation for chemical hazard,
Management of over-Exposure to chemicals ,
TLV concept.
As the audit proceeds, there might arise some situations where the facts indicate there is a failure, either partially or wholly, of the quality management system, such a situation is called nonconformity/ deficiencies”.
To cater a green environment of manufacturing industries, reponsible persons or designee, higher management, owners should go through it and implement as required as their scope for safety, health, profitable business to global customer response.
Critical Hazard Management System (CHMS)AnkitVasoya5
TOPIC ~ Critical Hazard Management System
What Is Hazards ?
Why Management ?
The most common hazards
How to prevent workplace from Hazards
Identification of Hazards
Risk Assessment
Controlling risk and Hazards
Risk / Hazard monitoring
References.
Role of quality system and audits in pharmamaceuticalganpat420
Introduction
cGMP Regulations
Quality Assurance Function
Quality Systems Approach
Management Responsibilities
Resources
Manufacturing Operations
Evaluation Activities
Transitioning to Quality Systems Approach
Audit Checklist for Drug Industry
Role of quality systems and audits in pharmaceutical manufacturing environmentMalay Pandya
By regulation, appropriate practice, and common sense, quality assurance (QA) is a critical function in the pharmaceutical manufacturing environment. The need for an independent unit to audit and comment on the appropriate application of standard operating procedures, master batch records, procedures approved in product applications, and the proper functioning of the quality control (QC) unit is paramount.
This helps assure that products are manufactured reliably, with adherence to approved specifications, and that current good manufacturing practices (cGMP) are maintained in conformance to regulation, both in the facility in general and the microenvironment of each product ’s manufacturing sequence.
This presentation describes outlines and discusses the regulations
applicable to the QA function and unit, structure, function and
application of the unit in the pharmaceutical manufacturing
environment. In addition, it discusses additional quality – related
responsibilities that may result when manufactures move toward a
quality system approach to quality that incorporates current quality
system models to further improve quality and harmonize with inter-
national quality requirements.
chemical Based Hazard, M.Pharm, Sem 2, Bhumi Suratiya, my presentation contains Regulation for chemical hazard,
Management of over-Exposure to chemicals ,
TLV concept.
As the audit proceeds, there might arise some situations where the facts indicate there is a failure, either partially or wholly, of the quality management system, such a situation is called nonconformity/ deficiencies”.
To cater a green environment of manufacturing industries, reponsible persons or designee, higher management, owners should go through it and implement as required as their scope for safety, health, profitable business to global customer response.
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https://www.natlenvtrainers.com | In this presentation, National Environmental Trainers takes a look at the far-reaching impacts that chemical exposures can have on various industries, and what can be done to ensure optimum levels of safety.
The following presentation discussess the changes to the OSHA HAZCOM standard to comply with the GHS rules. As of 1 Dec 13, all business should have completed the training to inform the workforce of the changes to product labels and containers as well as information provided on Safety Data Sheets. If you need help with your GHS policy, program, or procedures, contact us by telephone in the US at 1+ 7322215687 or by email at windsgroup@aol.com.
This slide is prepared based on fact data worldwide and also who . and it helps to course study for bachelor of pharmacy and health undergraduates degree subjects.
Dental occupational hazards & Safety Practices in Dental SettingsGhada Elmasuri
This ppt describes the biological, chemical, environmental, physical, and psychological workplace hazards that may apply to dentistry with specific standards to protect such exposure.
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Macroeconomics- Movie Location
This will be used as part of your Personal Professional Portfolio once graded.
Objective:
Prepare a presentation or a paper using research, basic comparative analysis, data organization and application of economic information. You will make an informed assessment of an economic climate outside of the United States to accomplish an entertainment industry objective.
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Artificial Intelligence (AI) technologies such as Generative AI, Image Generators and Large Language Models have had a dramatic impact on teaching, learning and assessment over the past 18 months. The most immediate threat AI posed was to Academic Integrity with Higher Education Institutes (HEIs) focusing their efforts on combating the use of GenAI in assessment. Guidelines were developed for staff and students, policies put in place too. Innovative educators have forged paths in the use of Generative AI for teaching, learning and assessments leading to pockets of transformation springing up across HEIs, often with little or no top-down guidance, support or direction.
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Management of over-Exposure to chemicals and TLV concept
1. Guided By :
Mrs. Preeti Bobade
ASSISTANT PROFESSOR
PHARMACEUTICAL
QUALITY ASSURANCE
Prepared By :
Mr. Swaraj M. Lohar
MQA08
PHARMACEUTICAL
QUALITY ASSURANCE
R.C.PATEL INSTITUTE OF PHARMACEUTICAL EDUCATION AND RESEARCH, SHIRPUR
19-07-2023 1
2. INTRODUCTION
TYPES OF HAZARDS
EFFECTS & DIFFERENT WAYS TO CAUSE
CHEMICAL HAZARDS
GUIDELINES FOR CHEMICAL SAFETY
MANAGEMENT OF OVER EXPOSURE TO
CHEMICALS
TLV CONCEPT
REFERENCES
19-07-2023 2
CONTENTS
3. Chemical hazards are a major Occupational Health and Safety (OHS) issues in Pharma industry.
Management of chemical hazards requires the combined efforts of OHS specialists, including generalist OHS
professionals, occupational hygienists, and occupational health practitioners.
Chemical hazards produce by chemical synthesis or manufacturing, processing, transportation and that effect on
the human and environmental condition.
A chemical hazard is a type of occupational hazard caused by exposure to chemicals in the workplace.
Hazardous chemicals include: neurotoxins, immune agents, dermatologic agents, carcinogens, reproductive
toxins, asthma genes, pneumoconiotic agents, and sensitizers.
19-07-2023 3
INTRODUCTION
4. Chemical hazards are toxic, corrosive, irritant, carcinogenic, flammable, and mutagenic.
According to workplace hazardous materials information, chemical hazards are classified as:
CLASSES DESCRIPTION
A • Compressed gas
• Dissolved gas or liquefied gas
B • Flammable gases
• Flammable and combustible liquids
• Flammable solid
• Flammable aerosols
• Reactive flammable material
C • Oxidizing materials- oxidizer and organic peroxide
• Oxidizer: Chlorates, nitric oxide, peroxides, permanganates, perchlorates, nitrites, nitrates, and
easily oxidize metal powder
• Organic peroxide: Tetra hydro furan, diethyl ether, dioxane, and methyl isobutyl ether.
D • Poisonous and infectious materials. e.g.: Cyanides, tea salts, and asbestos
E • Corrosive materials. e.g.: Inorganic acids and bases, hydrogen fluoride
F • Dangerous reactive materials. e.g.: Ethylene dioxide, organic azides, Na, Li, Ca
• Pyrophosphoric materials. e.g.: White phosphorous, diethyl aluminium chloride, and lithium
19-07-2023 4
TYPES OF CHEMICAL
HAZARDS
6. 19-07-2023
EFFECTS OF CHEMICAL EXPOSURE TO HUMAN BODY:
• Skin burn
• Ache
• Anthrax
• Ulcer in hand, nose, etc.
• Cancer
• Irritation on windpipe
6
EFFECTS & DIFFERENT WAYS TO CAUSE
CHEMICAL HAZARDS
Chemical Hazards Can Enter and
Harm the Body by Four Main Routes:
7. 19-07-2023 7
Safety & Health Guidelines for the Chemical Industry by OSHA
Follow WHS act 2011:
The WHS regulations include specific duties for a person conducting a business or undertaking to manage
the risks to health and safety associated with using, handling, generating, and storing hazardous chemicals at
a workplace.
The duties include:
• Correct labeling of containers
• Pipework, using warning placards
• Outer warning placards and displaying of safety signs
GUIDELINES FOR CHEMICAL SAFETY
8. 19-07-2023 8
I. Removal From Exposure
• Immediate removal of the person from the display site is the first step
• If a disabled victim is to be rescued; the rescue workers must protect themselves
from contaminated atmosphere first
• Respirators and rescue lines are compulsory first aid
MANAGEMENT OF OVER EXPOSURE TO
CHEMICALS
10. 19-07-2023 10
II. RESUSCITATION
• Resuscitation means restoring the life of someone apparently dead (collapsed or
shocked).
• If the victim is apneic, resuscitation should start as soon as it is removed from the area.
• Sustainable care must be provided as with any other medical emergency.
11. 19-07-2023 11
III. DECONTAMINATION
• A victim whose skin or clothing has been contaminated requires immediate removal
of clothing and shoes.
• Then, a vigorous shower with soap and water is recommended, including attention to
nails and scalp.
12. 19-07-2023 12
IV. SYMPTOMATIC TREATMENT
• Acute overexposure can cause a series of signs and symptoms that require general
medical support, regardless of the specific agent. Examples include convulsive seizure
control, bronchospasm treatment, dehydration, and arrhythmias.
Bronchospasm treatment Symptoms of dehydration
Convulsive seizure control
13. 19-07-2023 13
The Threshold limit value (TLV) is defined as ‘The concentration in air that may be
breathed in without harmful effects for five consecutive 8 hour working days’.
American Conference of Government Industrial Hygienists has established
Threshold Limit Value (TLV) concept.
Not a regulatory requirement but a recommended guideline.
ACGIH has 677 chemicals with TLVs.
TLVs are published annually in a booklet containing exposure guidelines for many
commonly used substances.
TLV CONCEPT
14. 19-07-2023 14
• The workers should not be exposed to the substances more than these limits.
• TLVs are only guidelines and are not intended as absolute boundaries between safe
and dangerous concentrations.
• Every occupational health professional should have a copy of the current TLVs.
• TLV of some pollutants in the environment:
Pollutants Threshold Limit Value (ppm)
CO2 500
CO 50
NO 25
NO2
5
SO2 5
15. 19-07-2023 15
Average
exposure on the
basis of 8h/day,
40h/week work
schedule
Maximum
concentration a
person can
exposed for a
period of 15
minutes
The airborne
concentration
substance
which may not
be exceeded
16. 19-07-2023 16
Case Study
In Amravati: Six workers died in a poisonous gas leak at a private steel mill rolling
unit in Anantpuram district.
Carbon monoxide is the main gas used for reheating process and its leak caused the
mishap.
19-07-2023 16
17. 19-07-2023 17
1. Bhusnure, O.G., Dongare, R.B., Gholve, S.B. and Giram, P.S., 2018. Chemical hazards and safety
management in pharmaceutical industry. Journal of Pharmacy Research, 12(3), pp.357-369.
2. Threshold Limit Value - an overview | ScienceDirect Topics
3. https://www.sciencedirect.com/topics/engineering/threshold-limit-value
4. Agarwal, P.R.I.N.C.Y., Goyal, A. and Vaishnav, R., 2018. Chemical hazards in pharmaceutical
industry: An overview. Asian J. Pharm. Clin. Res, 11, pp.27-35.
REFERENCES
