Регуляторные исследования и экспертиза лекарственных средств (Feb 2018)
The development of the monographs for compoundED preparations for the state pharmacopoeia of Ukraine
Abstract
At present, there are certain topical issues related to the development of the standards for preparation and quality control of compounded medicines, the elaboration of quality assurance system for compounded preparations under the state policy implementation principles. One of the appropriate solutions is the introduction of general chapters and monographs to the State Pharmacopoeia. The structure of the Second Edition of the State Pharmacopoeia of Ukraine includes five general pharmacopoeia chapters for compounded preparations. The next work step is the development of the pharmacopoeia concept for the elaboration of pharmacopeia monographs for officinal prescriptions and their introduction to the national part of the pharmacopoeia. In order to fulfill the mentioned task, the approaches for assessing the quality of extemporaneous preparations should be approved, the quality control methods should be developed and validated, the validation of technological process should be performed, and the stability and the expiration dates should be examined. The algorithm and the stages of the elaboration of pharmacopeia monographs for compounded preparations are described in the article, the structure of monographs is proposed, the examples of monographs for intra pharmaceutical preparations and concentrated solutions are given.
