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Current good manufacturing practices establish uniform standards to ensure quality throughout the manufacturing, packaging, labeling, and holding of OTC medicines and dietary supplement products.

The purpose of stability testing is to provide evidence on how the quality of a drug product varies with time under the influence of a variety of environmental factors, such as temperature, humidity, and light, shelf life for the drug product and recommended storage conditions.

Industry Self-Regulation for Dietary Supplements

This document serves as a guideline for the preparation by suppliers and appropriate use by their customers of a Certificate of Analysis (COA) for Dietary Supplement Components.

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