Significance of Safety specification
Safety specification is a crucial document that details identified and potential risks associated with a medicinal product, along with any missing information. It serves as a standard to ensure the safety and effectiveness of pharmaceuticals over their shelf life, helping to mitigate risks and inform stakeholders about the product's safety profile. This documentation is essential for maintaining high safety standards in the pharmaceutical industry.
Synonyms: Safety standards, Safety requirements, Safety guidelines, Safety protocols, Guideline, Standard, Requirement, Regulation.
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The concept of Safety specification in scientific sources
Safety specification is a crucial document detailing identified and potential risks, as well as gaps in information about a medicinal product, while ensuring adherence to standards that guarantee the safety and effectiveness of pharmaceuticals over time.
From: Journal of Ayurveda and Holistic Medicine
(1) Established standards that ensure the safety and effectiveness of pharmaceuticals throughout their shelf life.[1]
From: World Journal of Pharmaceutical Research
(1) Safety specification is a document that outlines important identified risks, potential risks, and missing information regarding a medicinal product.[2]