Relevant issues of indicating drugs storage conditions in normative documentation and drug package design
Abstract
The article highlights the issues related to indication of drug storage conditions. It describes the approaches to indicating temperature requirements and to interpretation of the term «dry place». The article also provides the recommendations on setting the storage conditions for sterile drugs after dilution. It was concluded that the harmonization and standardization of the definitions related to storage conditions, as well as indication of the required warnings on packages, eventually help to ensure the quality, proper therapeutic effect and safety of the product during the shelf life.
Keywords
условия хранения,
сухое место,
упаковка,
маркировка,
storage conditions,
dry place,
package,
labelling
About the Authors
I. A. Prokopov
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation
Russian Federation
E. L. Kovaleva
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation
Russian Federation
L. I. Mit’Kina
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation
Russian Federation
A. V. Pichugin
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation
Russian Federation
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Review
For citations:
Prokopov I.A., Kovaleva E.L., Mit’Kina L.I., Pichugin A.V. Relevant issues of indicating drugs storage conditions in normative documentation and drug package design. The Bulletin of the Scientific Centre for Expert Evaluation of Medicinal Products. 2016;(3):26-30. (In Russ.)
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