Risk Assessment for Compounding Ointments Quality by Ishikawa Diagram Construction

Abstract

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. RezumatPână în prezent, medicamentele magistrale nu se supun înregistrării în nici o țară. De aceea se recomandă introducerea unui sistem de asigurare a calității și a unui proces de evaluare a riscurilor. Prezentul studiu identifică riscurile pentru calitatea unguentelor preparate în farmacie, cu ajutorul diagramei Ishikawa. Au fost definite șase categorii majore de riscuri (personal; ingrediente farmaceutice active și excipienți; echipamente și instalații; tehnologia de preparare; stabilitate; control al calității). Au fost identificați factorii ce se recomandă a fi monitorizați, alături de factorii de risc specifici, pentru această formă farmaceutică. Conformitatea și controlul acestora vor permite farmaciilor să producă în mod constant unguente cu o calitate adecvată, care să prevină posibilele reacții în urma administrării unei forme dozate cu o calitate necorespunzătoare. Similitudinea cerințelor autorităților de reglementare pentru prepararea și controlul calității unguentelor permite utilizarea rezultatelor obținute în acest studiu pentru a asigura calitatea acestora în diferite țări.

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