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Environment Safety in the Pharma Industry 

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Environment Safety in the Pharma Industry 

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"The rationale for excluding process water was possible skewing of E factors (thus rendering meaningful process comparison difficult), and the fact that water use would not constitute a significant environmental impact in most cases."

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“Green chemistry” refers to the promotion of safe, sustainable, and waste-minimizing chemical processes."

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"lower E factors have been shown to be indicative of reduced manufacturing costs,18,28 reflecting lower process materials inputs and outputs; reduced costs from hazardous and toxic waste disposal, improved manufacturing capacity utilization, and reduced energy demand"

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"lower E factors have been shown to be indicative of reduced manufacturing costs,18,28 reflecting lower process materials inputs and outputs; reduced costs from hazardous and toxic waste disposal, improved manufacturing capacity utilization, and reduced energy demand"

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"Any change to the synthesis process for an Active Pharmaceutical Ingredient (API) of a drug becomes increasingly challenging as the drug progresses through development, because there are increasing regulatory requirements at each phase, and process changes closer to the end of the manufacturing process have a larger potential impact on API quality."

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"We infer that at least 50% of the overall process waste is outsourced as part of the procured raw materials, since waste generation during early steps is amplified through yield losses of late synthesis steps as result of higher input requirements. "

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The cultural shift towards green chemistry has accelerated in recent years, as reflected by numerous review articles and books, and more focused research towards sustainable feedstock for pharmaceutical firms."

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"This outcome leads to higher environmental and economic costs for the firm, and a less favorable environmental impact than might be achieved under a different set of constraints."

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Environmental Regulations in the Pharma Industry

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Environmental Regulations in the Pharma Industry

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"The GAL will not only facilitate SMART green chemistry goal-driven process R&D within the industry through incorporation of ideality-adjusted process complexity and allow for better goal alignment of process R&D with operations, but it will also establish a reference standard that can be used by governments to initiate green-chemistry-based regulations and incentives."

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"Any change to the synthesis process for an Active Pharmaceutical Ingredient (API) of a drug becomes increasingly challenging as the drug progresses through development, because there are increasing regulatory requirements at each phase, and process changes closer to the end of the manufacturing process have a larger potential impact on API quality."

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"any fundamental change in technology, site, or manufacturing process (including any modification of the API synthesis that may affect its impurity profile) requires submission of a supplement and approval by FDA prior to distribution of the drug."