RADYOFARMASÖTİKLERİN KALİTE GÜVENCESİ VE KALİTE KONTROLÜ: GENEL BİR BAKIŞ

Amaç: Radyofarmasi, radyofarmasötik adı verilen, teşhis ve tedavi amaçlı kullanılan, farmasötik ve radyoaktif özellikleri bir arada taşıyan farmasötik formları inceleyen, geliştiren, kalite kontrollerini yapan, dağıtımı ve uygulaması ile uğraşan özel bir eczacılık alanıdır. Radyofarmasötikleri diğer konvansiyonel ilaçlardan ayıran en önemli fark; radyofarmasötiklerin radyonüklid içermesidir. Radyofarmasötikler insanlara uygulandığı için steril, pirojensiz, izotonik, izohidrik olmalı ve geleneksel ilaç için gerekli tüm kalite kontrol testlerine tabi olmalıdır. Ayrıca içerdikleri radyonüklid nedeniyle ek kalite kontrol testlerinin uygulanması da gereklidir. Bu derlemede radyofarmasötiklere uygulanan kalite kontrol testleri, hastane radyofarmasi laboratuvar tipleri ve İyi Radyofarmasi Uygulamaları (GRP) ele alınacaktır. Sonuç ve Tartışma: Radyofarmasötikler, farmakopelerin ilgili bölümlerinde belirtilen standartlara uygun olarak hazırlanmalıdır. Her radyofarmasötik serisi için farmakopelerde belirtilen testler ve kayıtlar tutulmalıdır. Radyofarmasötiklerin üretimi ve hazırlanması, steril preparatlar için İyi Üretim Uygulamaları ve radyoaktif ürünler için GRP uyarınca yapılmalıdır. Ancak kalite kontrol testlerini geçen radyofarmasötikler, doz kalibratörlerinde doz ölçümleri yapıldıktan sonra hastalara verilebilir. Böylece hastanın güvenliği ve faydası maksimize edilirken risk minimuma indirilir. Yarı ömrü kısa olan bazı radyofarmasötikler kalite kontrol testleri tamamlanmadan kullanılmaktadır. Bu durumda kalite güvence sisteminin etkinliği ve devamlılığı uygun aralıklarla test edilmelidir. Hastane radyofarmasi laboratuvarları tarafından yapılan işlemlere göre uluslararası standartlar Seviye IA/B, Seviye IIA/B ve Seviye IIIA/B/C olarak belirlenmişitr. Radyofarmasötiklerin kalite güvencesi, GRP kapsamında yeterli sayıda eğitimli personel, kalibre ve kontrolleri yapılmış cihazlar, uygun maddeler ve her aşamada belirlenen testlerin yapıldığı ve sonuçların doğru ve düzenli olarak kayıt altına alındığı bir çalışma düzeni ile sağlanır.

Anahtar Kelimeler:

İyi radyofarmasi uygulamaları, radyofarmasötikler, radyofarmasi laboratuvarı, kalite güvencesi, kalite kontrol

QUALITY ASSURANCE AND QUALITY CONTROL OF RADIOPHARMACEUTICALS: AN OVERVIEW

Objective: Radiopharmacy is a special field of pharmacy that examines, develops, conducts quality controls, deals with distribution and application of pharmaceutical forms called radiopharmaceuticals that are used for diagnostic and therapeutic purposes, carrying pharmaceutical and radioactive properties together. Radiopharmaceuticals contain radionuclides. This is the most important difference that distinguishes radiopharmaceuticals from other conventional drugs. Since radiopharmaceuticals are administered to humans, they must be sterile, pyrogen-free, isotonic, isohydric, and subject to all quality control tests required for conventional drug. Also, additional quality control tests are required due to radionuclide they contain. In this review, quality control tests applied to radiopharmaceuticals, hospital radiopharmacy laboratory types and Good Radiopharmacy Practices (GRP) will be discussed. Result and Discussion: Radiopharmaceuticals should be prepared in accordance with standards specified in relevant sections of pharmacopoeias. For each series of radiopharmaceuticals, tests prescribed in the pharmacopoeias and records must be kept. Production and preparation of radiopharmaceuticals should be carried out in accordance with Good Manufacturing Practices for sterile preparations and GRP for radioactive products. However, radiopharmaceuticals that pass quality control tests can be administered to patients after dose measurements are made in dose calibrators. Thus, the patient's safety and benefit are maximized, while the risk is minimized. Some radiopharmaceuticals with a short half-life are used before quality control tests are completed. In this case, the effectiveness and continuation of the quality assurance system should be tested at appropriate intervals. According to procedures performed by hospital radiopharmacy laboratories, international standards are determined as Level IA/B, Level IIA/B and Level IIIA/B/C. Quality assurance of radiopharmaceuticals is provided by a sufficient number of trained personnel within the scope of GRP, devices that have been calibrated and controlled, appropriate substances and a working order in which tests determined at each stage are made and results are recorded accurately and regularly.

Keywords:

Good radiopharmacy practices, radiopharmaceuticals, radiopharmacy lab, quality assurance, quality control,

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