Stability Data vs. USP 36 <1079> Good Storage and Distribution Practices for for Drug Products
In our application notes and articles about environmental management in pharmaceutical, biotechnology, and medical device applications we usually stay at the level of principles because every scenario is different. Guidance documents are written broadly for just this reason: the needs of each product and the parameters of each environment will, more than all other factors, determine how you will apply regulations and guidance.
Having said that, along with providing monitoring and validationsystems, we enjoy delving a little deeper into some of the issues that come up in the applications of our customers.In this article we discuss considerations for understanding the USP 36 “General Notices and Requirements” which represents the basic “assumptions, definitions, and default conditions” for interpreting and applying the United States Pharmacopeia (USP) and theNational Formulary in industry applications.
CASE STUDY:
One of our US-based customer stores finished sterile injectables in a controlled room-temperature warehouse. The products are manufactured to USP requirements and product packaging requires room temperature or less than 25°C. The alarm limits for the warehouse are 15°C to 25°C. They do not calculate MKT for continuous temperature monitoring probes.
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Source: Vaisala
