Sunayana Nidadavolu

The Importance of Chemistry, Manufacturing, and Controls (CMC) Regulatory Documentation in Pharmaceuticals

Sunayana Nidadavolu10 months ago10 months ago04 mins

The Importance of Chemistry, Manufacturing, and Controls (CMC) Regulatory Documentation in Pharmaceuticals Chemistry, Manufacturing, and Controls (CMC) regulatory documentation is a critical component in the pharmaceutical and biological product development process. It ensures that these products meet the necessary standards for quality, safety, and efficacy. Below are some key components that make up CMC documentation:…

Drug scheduling

Sunayana Nidadavolu10 months ago10 months ago03 mins

Drug scheduling – a classification system used by regulatory authorities to control the availability of medicines to the public based on their safety risk and potential for abuse. Medicines and chemicals are categorized into different schedules, each with specific rules regarding their sale, purchase, storage, and disposal. The scheduling system helps ensure public health and…

Extractables and Leachables

Sunayana Nidadavolu10 months ago10 months ago03 mins

Extractables and leachables are critical considerations in the development and quality control of injectable drug products. Extractables are chemical compounds that can be extracted from packaging materials, container closures, or delivery systems when exposed to solvents under exaggerated conditions (e.g., high temperatures, aggressive solvents). Leachables are chemical compounds that migrate into the drug product under…

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