World experience of the monograph development for compounding preparations
The practice of compounding and quality control of compounding preparations are different all over the world. There is no common approach of quality assurance system creating for compounding preparations that leads to the existence of a number of risks and problems associated with their quality and safety. Based on the world experience, modern approaches of compounding preparation quality assurance are the implementation of good practices, pharmacopoeia concept formation, national formulary creation and development of monographs for extemporaneous preparations.
The aim of this article was a comparative analysis conduction of compounding preparation monographs which are given in pharmacopoeias and national formularies in different countries of the world.
The more detailed comparison was made for monographs structure of compounding preparation which are given in the British Pharmacopoeia, the US Pharmacopoeia, National formularies of France, Germany and Malaysia.
In the result of the analysis the most specific parts of compounding preparation monographs were identified, such as: composition, technology, common pharmacopoeial requirements, range of ingredients content, properties, tests, assay, expiration date, labeling, storage, and indications. Today in Ukraine questions of compounding preparation monographs creating remain under discussion.
It is necessary to consider establishing a National formulary in Ukraine, which would include all the features of technology and quality control of compounding preparations.
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