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What is the Scale-Up Process in Pharma Manufacturing? The scale‑up process is the structured progression of increasing batch production—from laboratory or bench scale, through pilot scale, up to commercial manufacturing—while maintaining consistent formulation attributes and product quality. Its aim is a seamless transition from development to commercial supply. Why is Scale-Up Critical in Pharma? Scale‑up is essential to: Meet clinical […]
What Is an SDS (Safety Data Sheet)? A Safety Data Sheet (SDS) is a standardized document that provides critical safety, hazard, and handling information about a chemical substance or mixture. In pharmaceuticals, it applies to APIs, intermediates, excipients, and solvents used in R&D and manufacturing. SDS documents follow the GHS (Globally Harmonized System) 16-section format. Why Is an SDS Important in Pharma?
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What is Software as a Medical Device (SaMD)? Software as a Medical Device (SaMD) refers to standalone software designed for medical purposes, such as diagnosis, prevention, monitoring, or treatment of disease that operates without being embedded in hardware. Defined by the International Medical Device Regulators Forum (IMDRF), SaMD includes digital tools like AI diagnostic software, clinical decision support systems, and remote monitoring apps.
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What is a Swiss Free Sale Certificate (SFSC)? A Swiss Free Sale Certificate (SFSC) is an official export document issued by Swissmedic, Switzerland’s regulatory authority for therapeutic products. It confirms that a pharmaceutical, medical device, or cosmetic product is legally marketed and freely available in the Swiss market. This certificate assures foreign authorities that the
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