Badan Pengawas Obat dan Makanan Republik Indonesia ...

Aneks 9 – Pembuatan Radiofarmakadiandalkan untuk menerapkan bagianCPOB yang relevan dan tidak mengidappenyakit atau berada dalam kondisiyang dapat memengaruhi integritasproduk. Tes kesehatan personilhendaklah dilakukan pada saatperekrutan dan kemudian secaraberkala. Perubahan status kesehatanpersonalia (misal dari hasil teshematologi) dapat mengakibatkanpersonalia tersebut dikeluarkansementara dari area di mana terdapatpaparan sinar radiasi.13. Jumlah personalia yang diperbolehkanberada di area bersih dan area aseptishendaklah dibatasi ketika prosessedang berjalan. Akses ke area inihendaklah dibatasi selama prosespersiapan radiofarmaka, kit ataukomponen penunjang steril. Sedapatmungkin inspeksi dan prosedurpengendalian hendaklah dilaksanakandari luar area.14. Saat bekerja, personalia dapat melewatiarea radioaktif dan nonradioaktif namunharus mengikuti peraturan keselamatantentang pengendalian radiasi(pengendalian fisika medis).15. Pelulusan bets untuk industriradiofarmaka hendaklah mendapatpersetujuan hanya dari KepalaPemastian Mutu yang berpengalamandalam bidang pembuatan radiofarmaka.Catatan: Pelulusan bets produk darifasilitas di luar industri radiofarmakamisal: rumah sakit diatur terpisah –Lihat: Paragraf Radiofarmasi RumahSakit Butir 156-183.16. Untuk memastikan keselamatan kerjadalam pembuatan radiofarmaka, parapersonalia hendaklah mendapatkanpelatihan mengenai CPOB, penangananyang aman terhadap bahan radioaktifdan prosedur keselamatan radiasi.Personalia wajib mengikuti pelatihanberkala agar dapat mengikutiperkembangan terbaru dalambidangnya.Annex 9 – Manufacture ofRadiopharmaceuticalsappropriate codes of practice and arenot subject to any disease or conditionthat could compromise the integrity ofthe product. Health checks on personnelshould be requested before employmentand periodically thereafter. Any changesin personal health status (e.g. inhaematology) may require thetemporary exclusion of the person fromfurther radiation exposure.13. Only the minimum number of personnelrequired should be present in clean andaseptic areas when work is in progress.Access to these areas should berestricted during the preparation ofradiopharmaceuticals, kits or sterile setups.Inspection and control proceduresshould be conducted from outside theseareas as far as possible.14. During the working day, personnel maypass between radioactive and nonradioactiveareas only if the safety rulesof radiation control (health physicscontrol) are respected.15. In a radiopharmaceutical industry, therelease of a batch should be approvedonly by the head of Quality Assurancewith appropriate experience in themanufacture of radiopharmaceuticals.Note: The release of a batch of productfrom a facility other than aradiopharmaceutical industry e.g. ahospital radiopharmacy, is regulatedseparately – See under ParagraphHospital Radiopharmacy Points 156-183.16. To ensure the safe manufacture ofradiopharmaceuticals, personnel shouldbe trained in GMP, the safe handling ofradioactive materials and radiationsafety procedures. They should also berequired to take periodic courses andreceive training to keep abreast of thelatest developments in their fields.Edisi 2009 - 52 - 2009 Edition