9/24/2023 0 Comments Usp 37 pdf![]() ![]() ![]() Figure 1 documents present-day routes and the associated risks. A Pharmacopeial preparation may follow several potential routes from the original manufacturer to the patient. ![]() This calibration should be based on NIST or international standards (see Monitoring Devices—Time, Temperature, and Humidity 1118 ). All equipment used for recording, monitoring, and maintaining temperatures and humidity conditions should be calibrated on a regular basis. The section Preservation, Packaging, Storage, and Labeling under General Notices and Requirements provides definitions for storage conditions. There is no change to any applicable requirements under Current Good Manufacturing Practices, approved labeling, state laws governing pharmacies, the USP General Notices and Requirements, or monographs. It describes procedures to maintain proper storage environments for individual articles and to ensure a preparation's integrity, including its appearance, until it reaches the user. This general information chapter is intended to provide general guidance concerning storing, distributing, and shipping of Pharmacopeial preparations. ![]()
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