Romanian Society of Pharmaceutical Sciences
 

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RISK ASSESSMENT FOR COMPOUNDING OINTMENTS QUALITY BY ISHIKAWA DIAGRAM CONSTRUCTION

LESIA SAVCHENKO 1*, YURI PIDPRUZHNYKOV 2, LIUDAS IVANAUSKAS 3, AUDRIUS
LUKOŠIUS 4, VICTORIYA GEORGIYANTS 5

1Department of Quality, Standardization and Certification of Medicines, Institute of Pharmacy Professionals Qualification
Improvement, National University of Pharmacy, 17 Zahysnynykiv Ukrainy Square, 61001, Kharkiv, Ukraine
2 Department of Quality Management, National University of Pharmacy, 4 Valentynivska Street, 61000, Kharkiv, Ukraine
3 Department of Analytical and Toxicological Chemistry, Lithuanian University of Health Sciences, 9 A. Mickevičiaus Street, 44307, Kaunas, Lithuania
4 Department of Pharmacognosy, Lithuanian University of Health Sciences, 9 A. Mickevičiaus Street, 44307, Kaunas,
Lithuania
5 Department of Pharmaceutical Chemistry, National University of Pharmacy, 4 Valentynivska Street, 61000, Kharkiv, Ukraine

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To date compounding medicines don’t need to pass the state registration process in any country. In order to ensure their quality, the introduction of a pharmaceutical quality system with risk assessment process is recommended in most countries worldwide. This research identifies the risks for quality of compounding ointments by Ishikawa diagram construction. Six major categories of risks (personnel; active pharmaceutical ingredients (API) and excipients; equipment and facilities; preparation technology; stability; quality control) were defined. Factors recommended to be monitored and specific risk factors for this dosage form quality were also identified. Their compliance and control will allow pharmacies to produce constantly ointments with appropriate quality and to prevent harm to the patient from administration of dosage forms with a lower quality. The similarity of the regulatory framework requirements for the preparation and quality control of the compounding ointments allows using the obtained results to ensure their quality in different countries.