This document summarizes the key requirements of the OSHA Hazard Communication Standard, including requirements for chemical manufacturers to classify hazards, and for employers to label containers, maintain safety data sheets, and provide training to employees. It also lists several hazardous chemicals commonly found in sterile processing departments, along with their primary hazards and exposure limits according to OSHA, ACGIH and NIOSH.
Current Good Manufacturing Practices in Food IndustryPECB
Good manufacturing practice (GMP) is a system for ensuring that products are consistently produced and controlled according to the quality standards. There are many risks: unexpected contamination of products, causing damage to health or even death; incorrect labels on container, etc. This webinar will guide you through all of the requirements, steps you need to take going from concepts to implementation of appropriate measures.
Main points covered:
• Current good manufacturing practice (CGMP) requirements
• A Quality Management System for medical devices Required By FDA (Food & Drug Association) USA
• From Concepts to implementation
Presenter:
This webinar was presented by PECB Certified Trainer, who is also a senior consultant, trainer and coach in Occupational Health and Safety, Mr. Raza Shah.
Link of the recorded session published on YouTube: https://youtu.be/9ZTtnAQn3HQ
This presentation consists of information related to Schedule M, a topic under #Drug_and_Cosmetics_Act. This presentation could be beneficial for the sake of the seminar in #Pharmaceutical_Jurisprudence for pharmacy students.
Current Good Manufacturing Practices in Food IndustryPECB
Good manufacturing practice (GMP) is a system for ensuring that products are consistently produced and controlled according to the quality standards. There are many risks: unexpected contamination of products, causing damage to health or even death; incorrect labels on container, etc. This webinar will guide you through all of the requirements, steps you need to take going from concepts to implementation of appropriate measures.
Main points covered:
• Current good manufacturing practice (CGMP) requirements
• A Quality Management System for medical devices Required By FDA (Food & Drug Association) USA
• From Concepts to implementation
Presenter:
This webinar was presented by PECB Certified Trainer, who is also a senior consultant, trainer and coach in Occupational Health and Safety, Mr. Raza Shah.
Link of the recorded session published on YouTube: https://youtu.be/9ZTtnAQn3HQ
This presentation consists of information related to Schedule M, a topic under #Drug_and_Cosmetics_Act. This presentation could be beneficial for the sake of the seminar in #Pharmaceutical_Jurisprudence for pharmacy students.
Schedule M is good manufacturing practices and requirements of premises, plants and equipment for pharmaceutical products.
Schedule M is a part of drugs and cosmetics act, 1940.
Schedule M- І:Requirements of factory premises for manufacture of homoeopathic preparations.
Schedule M- ІІ: :Requirements of factory premises for manufacture of cosmetics.
Schedule M- ІІІ: :Requirements of factory premises for manufacture of medical devices.
Good Manufacturing Practice (GMP) | Arrelic InsightsArrelic
Good manufacturing practice (GMP) is that part of quality assurance which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the marketing authorization. GMP is aimed primarily at diminishing the risks inherent in any pharmaceutical production, which may broadly be categorized in two groups: cross contamination/mix-ups and false labeling. Above all, manufacturers must not place patients at risk due to inadequate safety, quality or efficacy; for this reason, risk assessment has come to play an important role in WHO quality assurance guidelines.
Cosmetic products animal testing in the EU - legislationTadej Feregotto
This presentation explains the rules and legislation regarding animal testing of cosmetic products in the EU and its development over the last few years.
Quality of drugs is basically responsibility of manufacturers & GMP guidelines are a means to assure very quality.
Draft of GMP regulations was prepared in 1975 which could be finalized & implemented in 1988, in form of amended schedule M.
It embraces Rule 71,74,76 & 78 under D & C Rules 1945.
To achieve objectives of GMP, licensee shall comply with requirements of GMP as laid down in Schedule M.
Part I deals with GMP relating to factory premises, & Part II deals with plant & equipment for manufacture of drugs.
Master of Good Manufacturing Practice - Course Detailsutspharmacy
Staff who hold postgraduate degrees in Good Manufacturing Practice (GMP) are essential for many pharmaceutical, biologic, medical device and food manufacturing companies.
This presentation provides an overview of the Master of Good Manufacturing Practice offered at the University of Technology, Sydney (UTS) in Australia. For more information visit www.gmp.uts.edu.au
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.
Schedule M is good manufacturing practices and requirements of premises, plants and equipment for pharmaceutical products.
Schedule M is a part of drugs and cosmetics act, 1940.
Schedule M- І:Requirements of factory premises for manufacture of homoeopathic preparations.
Schedule M- ІІ: :Requirements of factory premises for manufacture of cosmetics.
Schedule M- ІІІ: :Requirements of factory premises for manufacture of medical devices.
Good Manufacturing Practice (GMP) | Arrelic InsightsArrelic
Good manufacturing practice (GMP) is that part of quality assurance which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the marketing authorization. GMP is aimed primarily at diminishing the risks inherent in any pharmaceutical production, which may broadly be categorized in two groups: cross contamination/mix-ups and false labeling. Above all, manufacturers must not place patients at risk due to inadequate safety, quality or efficacy; for this reason, risk assessment has come to play an important role in WHO quality assurance guidelines.
Cosmetic products animal testing in the EU - legislationTadej Feregotto
This presentation explains the rules and legislation regarding animal testing of cosmetic products in the EU and its development over the last few years.
Quality of drugs is basically responsibility of manufacturers & GMP guidelines are a means to assure very quality.
Draft of GMP regulations was prepared in 1975 which could be finalized & implemented in 1988, in form of amended schedule M.
It embraces Rule 71,74,76 & 78 under D & C Rules 1945.
To achieve objectives of GMP, licensee shall comply with requirements of GMP as laid down in Schedule M.
Part I deals with GMP relating to factory premises, & Part II deals with plant & equipment for manufacture of drugs.
Master of Good Manufacturing Practice - Course Detailsutspharmacy
Staff who hold postgraduate degrees in Good Manufacturing Practice (GMP) are essential for many pharmaceutical, biologic, medical device and food manufacturing companies.
This presentation provides an overview of the Master of Good Manufacturing Practice offered at the University of Technology, Sydney (UTS) in Australia. For more information visit www.gmp.uts.edu.au
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 presentation addresses the key changes to the Hazard Communication standard and associated inspection procedures, including hazard classification, labeling and safety data sheets. It also provides guidelines for updating your written hazard communication program.
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.
Finding Chemical Exposures & Negotiating Fixes v2zq
Finding Chemical Exposures & Negotiating Fixes - Resources for Healthy Children www.scribd.com/doc/254613619 - For more information, Please see Organic Edible Schoolyards & Gardening with Children www.scribd.com/doc/254613963 - Gardening with Volcanic Rock Dust www.scribd.com/doc/254613846 - Double Food Production from your School Garden with Organic Tech www.scribd.com/doc/254613765 - Free School Gardening Art Posters www.scribd.com/doc/254613694 - Increase Food Production with Companion Planting in your School Garden www.scribd.com/doc/254609890 - Healthy Foods Dramatically Improves Student Academic Success www.scribd.com/doc/254613619 - City Chickens for your Organic School Garden www.scribd.com/doc/254613553 - Huerto Ecológico, Tecnologías Sostenibles, Agricultura Organica www.scribd.com/doc/254613494 - Simple Square Foot Gardening for Schools - Teacher Guide www.scribd.com/doc/254613410 - Free Organic Gardening Publications www.scribd.com/doc/254609890 ~
SM-102-A-0.02 Hazard Communication in the SPD Poster January 2016
1. January 2016 ChemDAQ Inc 300 Business Center Drive • Pittsburgh, PA • 15205, 1-800-245-3310 ext. 530 Doc. No. SM-102-A-0.02
www.chemdaq.com, www.chemdaq.com/blog/
Hazard Communication Training in the SPD/CSSD/CSD
Hazard Communication Standard1
Legal Background
1970 Occupational Health & Safety Act created the Occupational Safety and
Health Administration (OSHA) and empowered OSHA to create and enforce
workplace safety standards.
29 CFR 1910.1200 Hazard Communication Standard
• Requires chemical manufacturers or importers to classify the hazards of
chemicals which they produce or import
• Employers must provide information to their employees about the
hazardous chemicals to which they are exposed, by means of a hazard
communication program, labels and other forms of warning, safety data
sheets, and information and training. [b(1)]
Standard Includes the following requirements:
• Assess hazards
• Labels and markings
o Include Product identifier, hazard statements, pictogram,
precautionary statements, name & address of manufacturer or
responsible party. [f(1)]
o The chemical manufacturer, importer, or distributor shall ensure
that each container of hazardous chemicals leaving the workplace
is labeled, tagged, or marked.[f(1)]
o Labels not required for portable containers for immediate use [f(8)]
o Labels shall be in English and optionally also in other languages if
spoken by workers
• Safety Data Sheets (SDSs)
o Maintain for all chemicals in the workplace and accessible to
workers [g(8)]
o Sections include: Identification, Hazard Identification,
Composition, First Aid Measures, Fire fighting Measures,
Accidental Release Measures, Handling & Storage, Exposure
Controls & Personal Protection, Physical & Chemical Properties,
Stability and Reactivity, Toxicology, Ecological Information,
Disposal, Transportation, Regulations, Other Information including
date of last revision. [g(2)]
o Suppliers will provide with first shipment and shipments after SDS
revision [g(6)]
• Training
o Employers shall provide employees with effective information and
training on hazardous chemicals in their work area at the time of
their initial assignment, and whenever a new chemical hazard the
employees have not previously been trained about is introduced
into their work area. [h(1)]
o Training shall include: [h(3)]
Requirements of this standard
Operations using hazardous chemicals,
Location of written plan, SDSs and chemical list,
Methods and observations that may be used to detect the
presence or release of a hazardous chemical in the work area
(such as monitoring conducted by the employer, continuous
monitoring devices, visual appearance or odor of hazardous
chemicals when being released, etc.);
The physical, health, simple asphyxiation, combustible dust,
and pyrophoric gas hazards, as well as hazards not otherwise
classified, of the chemicals in the work area
The measures employees can take to protect themselves from
these hazards, including specific procedures the employer has
implemented to protect employees from exposure to hazardous
chemicals, such as appropriate work practices, emergency
procedures, and personal protective equipment to be used;
and,
Details of the hazard communication program developed by
the employer, including an explanation of the labels received
on shipped containers and the workplace labeling system used
by their employer; the safety data sheet, including the order of
information and how employees can obtain and use the
appropriate hazard information.
o If multiple employers, then must ensure that all employees
potentially exposed to chemicals are trained [(2)]
• Written plan [e(1)]
o List of chemicals on site
o The methods the employer will use to inform employees of the
hazards of non-routine tasks
• Chemical Inventory
• Trade secrets – information can be kept as trade secrets so long as
safety information is not withheld and composition is made available in
case of emergency. [i]
[x] refers to sections in the standard.
1
Full text available from
http://www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=standa
rds&p_id=10099
Pictograms
Standard pictograms indicating chemical hazards have been developed under the
Globally Harmonized System of Classification and Labeling of Chemicals
(GHS);2
some of which are shown below. OSHA has adopted the GHS and
updated the Hazard Communication Standard in 2012.
Hazardous Chemical Compounds Commonly Found in Sterile
Processing Departments Used for Sterilization and High Level
Disinfection
RTECS Description
Compound
Primary
Irritant
Strong
Oxidizer
Tumorigen
Mutagen
Reproductive
Effects
Hormonal
Effects
Carcinogen
Ethylene Oxide √ √ √ √ √
Hydrogen
Peroxide
√ √ √ √ √ Animals (ACGIH)
Glutaraldehyde √
Ozone √ √
Peracetic Acid √ √ √ See Hydrogen
peroxide
Registry of the Toxic Effects of Chemical Substances (NIOSH)
Exposure Limits (8 Hr TWA ppm, except as stated otherwise)a
Compound
OSHA
PELb
(8
HrTWA)
(ppm)
ACGIH
(ppm)
NIOSH
IDLHb
()
Other
Ethylene Oxide 1.0, 5
STELd
1.0 800
Hydrogen
Peroxide
1.0 1.0 75 HI & WA State 3 ppm
STEL
Glutaraldehyde C 0.05 C
0.2
UK WEL 0.05 ppm 8Hr
& STELf
Ozone 0.1 0.05 –
0.2e
5.0
Peracetic Acid 0.4
STEL
0.17, EPA AEGL 1
(10 min–8Hr TWA)
a) C = Ceiling, STEL = short term exposure limit, IDLH = immediately dangerous to life and health
b) 29 CFR 1910.1000, Tbl. Z-1, http://www.cdc.gov/niosh/idlh/intridl4.html
c) http://www.cdc.gov/niosh/idlh/intridl4.html
d) EtO STEL also known as excursion limit (29 CFR 1910.1047(c)(2)
e) TLV varies from 0.05 ppm heavy work (Hrs) to 0.1 light work, 8 Hr TWA; 0.2 ppm for < 2 hrs
f) UK Workplace Exposure Limits, EH40/2005 (2nd
Ed, 2011).
2
Further information about the GHS is available from
http://www.osha.gov/dsg/hazcom/ghs.html