A proactive approach, coupled with properly planned and implemented safety and risk management systems can help you comply with local, state and federal PSM regulations, as well as minimize loss of life, environmental impact, equipment damage, citations and litigation.
ioMosaic pioneered many of the current risk assessment techniques for processes that handle hazardous chemicals.
Our experts support every aspect to ensure that your facility runs safely and efficiently.
Expertise to help you minimize your exposure to fire, injury, property damage, and litigation.
Integrating best practices with cost-effective solutions to address program deficiencies.
Helping manage risk with facility siting studies, assessments and recommendations.
Senior knowledgeable engineers facilitate PHAs or DHAs in nearly all sectors of the process and processing industries.
Decades of experience leading incident investigations for process industry companies.
We prepare expert opinion reports and provide expert testimony for process incident cases.
Experienced engineers who have performed LOPAs on a wide range of facilities and terminals.
Our experts are at the forefront of pipeline Process Safety Management proficiency.
Proven track record of performing QRAs for facilities, pipelines and transportation routes.
Well versed in assisting global companies with their sustainability reporting communications.
Decades of experience mitigating hazards for the chemical and pharmaceutical industries.
A global specialty chemicals company that is known for manufacturing ingredients used in pharmaceuticals, personal care products, nutrition, agriculture, and sectors impacted by green technologies, needed an in-depth evaluation of its chlorine handling operations against specific standards. Read the case study and learn the advantages of working with ioMosaic.
If your facility uses, stores, manufactures, handles, or moves flammable or highly hazardous chemicals on site above the threshold quantity (TQ), OSHA does require PSM implementation. Learn the facts about process safety management.
Today, the process industries need to be certain that their stakeholders have confidence in how they manage the environmental, health, security, and safety implications of industrial activities. Read this white paper for a systematic, risk-based approach to safe design that can help to eliminate hazards that pose high risks from the process and help mitigate.
Many companies who are regulated by current Good Manufacturing Practices (or cGMP) are discovering that they are also required to comply with process safety management regulations such as PSM in the U.S. or Seveso or COMAH in Europe. And chemical and petrochemical companies who have been regulated for years under PSM are now starting to produce pharmaceutical products that are regulated under cGMP. While cGMP and PSM regulate different hazards, the management systems that are needed to comply with each regulation are often the same. This paper will address the elements of the U.S. PSM regulation and compare those requirements to the US cGMP regulations to show how the same management systems can be used to simultaneously comply with both regulations.
Process safety regulations protect people, assets, and the environment by managing hazards associated with the release of hazardous chemicals and other energy sources. Current Good Manufacturing Practices (or cGMP) regulations protect people and animals from the adulteration of food and drugs that makes the product impure, unsafe, or unwholesome. 21 US Code 342 & 351 define adulterated food and drugs in detail. While the goals of the two regulations are different, they both contain similar requirements that can utilize the same management systems to comply with both regulations simultaneously. This paper will compare the key elements from the U.S. Process Safety Management (PSM) requirements from 29 CFR 1910.119 with the International Conference on Harmonization (ICH) Q7 which is cGMP for Active Pharmaceutical Ingredients (APIs). The cGMP requirements for food, dietary supplements, drugs, and excipients have similar requirements, but the related references will not be detailed in this paper. For more information on these topics, please reference 21 CFR 110 for cGMP for human food; 21 CFR 111 for cGMP for dietary supplements; 29 CFR 210 for drugs; 21 CFR 211 for finished pharmaceuticals; and the International Pharmaceutical Excipient Council (IPEC) for cGMP excipient guidelines.
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