Journal of Drug Design and Medicinal Chemistry 2016; 2(6): 74-78 http://www.sciencepublishinggroup.com/j/jddmc doi: 10.11648/j.jddmc.20160206.13 ISSN: 2472-355X (Print); ISSN: 2472-3576 (Online) Validation of Soothing Compounding Mixture Technological Process Preparation Lesia Savchenko 1, * , Victoriya Georgiyants 2 1 Department of Quality, Standardization and Certification of Medicines, Institute of Pharmacy Professionals Qualification Improvement, National University of Pharmacy, Kharkiv, Ukraine 2 Department of Pharmaceutical Chemistry, National University of Pharmacy, Kharkiv, Ukraine Email address: savchenkolesia@gmail.com (L. Savchenko) * Corresponding author To cite this article: Lesia Savchenko, Victoriya Georgiyants. Validation of Soothing Compounding Mixture Technological Process Preparation. Journal of Drug Design and Medicinal Chemistry. Vol. 2, No. 6, 2016, pp. 74-79. doi: 10.11648/j.jddmc.20160206.13 Received: October 31, 2016; Accepted: November 26, 2016; Published: January 11, 2017 Abstract: Validation of soothing compounding mixturetechnological process preparation in accordance with the requirements of the quality system organization was done. It is preparingserially in many pharmacies of Ukraine. Obtained results indicate conformity of the finished medicine quality with the regulatory framework requirements of Ukraine in regard to the content of all mixture components. Keywords: Technological Process Validation, Compounding Preparation, Soothing Mixture 1. Introduction There was decreasing of compounding preparations (CP) volume and number of compounding pharmacies until recent times in Ukraine. Large pharmacies which manufacturing a variety of dosage forms (DF) for stock and by individual prescriptions are appearing nowadays. Therefore, more often problem of approaches to their quality monitoring is discussing. The harmonization of national legislation of Ukraine with international and European standards is observingnow. Adaptation of legislation forensuring medicines quality in accordance with the Guidelines adopted in the European Union [1] takes place as a part of this process. In particular, this applies to the State Pharmacopoeia of Ukraine (SPhU) and a range of quality Guidelines [1]. The Pharmacopoeial Centre of Ukraine was granted observer status in the European Directorate for the Quality of Medicines in 1998, which was changed on full membership in 2013. Articles of the SPhU completely had harmonized with the European Pharmacopoeia (EP), but also contain national parts that have advisory and informational purposes. In addition, SPhU contains articles that EP is not content. It is also applying to the section "Medicinal products prepared in pharmacies" [2] which was entered into the second edition of the SPhU. It contains six general articles which are regulating the quality of compounding non-sterile medicines, powders, ointments and suppositories. In accordance with the requirements ofthe SPhUarticle "Non- sterile compounding medicines" their production technology should ensure compliance with general articles about DF and existing regulations. Preparation of drugs for stock should be done by the previously developed technological instructions with indicating of necessary equipment, preparationstandards, quality control methods, quantitative indicators with acceptable limits, labeling, conditions of storage and shelf life. In addition, a quality requirement to the CP common article «Medicines» of the SPhU contains [3]. It stated that during their preparation is necessary to conduct a risk assessment that would identify criticalnessof various parameters impact on the medicines quality (e.g., the quality of active substances and excipients, preparation process mode, stability of medicine) and a negative impact on patients' health. This statement was introduced to the second edition of SPhU for the first time. Attention to the CP quality also the adoption of Good Pharmacy Practice basic standards, developed by International Pharmaceutical Federation and World Health Organizationemphasizes [4]. Itclaims the quality standards of