Ditemukan 184348 dokumen yang sesuai dengan query
Rifa Nadya Syahira
"Inspeksi diri merupakan salah satu prinsip CDOB untuk mengusulkan langkah-langkah perbaikan yang diperlukan. Laporan ini mengevaluasi pelaksanaan inspeksi diri terkait pengelolaan narkotika dan psikotropika di PT Kimia Farma Trading & Distribution (KFTD) Cabang Bogor selama Februari 2024 berdasarkan dokumen formulir inspeksi diri yakni FORM/LOG/QA/077. Inspeksi diri bertujuan untuk memastikan kepatuhan terhadap regulasi sesuai standar Cara Distribusi Obat yang Baik (CDOB) guna menjamin keamanan, khasiat, dan mutu obat. Metode yang digunakan meliputi observasi, wawancara, dan analisis dokumen serta SOP terkait pengadaan, penyimpanan, penyaluran, dan dokumentasi. Hasil evaluasi menunjukkan KFTD Bogor telah memenuhi standar yang ditetapkan Badan POM. Pengelolaan narkotika dan psikotropika dilakukan dengan langkah-langkah yang sistematis dan sesuai peraturan, termasuk pengendalian akses, pemisahan ruang penyimpanan, dan dokumentasi tertib. Namun, formulir inspeksi diri perlu diaudit terlebih dahulu serta diperlukan perbaikan seperti penerapan penyimpanan alfabetis untuk meningkatkan efisiensi pengelolaan. Kesimpulannya, inspeksi diri telah dilaksanakan dengan baik, dan hasilnya menunjukkan tingkat kepatuhan yang tinggi terhadap regulasi yang berlaku, memberikan jaminan pengelolaan yang aman dan bertanggung jawab atas narkotika dan psikotropika di PT Kimia Farma Trading & Distribution (KFTD) Cabang Bogor.
Self-inspection is a key principle of Good Distribution Practices (GDP) to propose necessary improvement measures. This report evaluates the implementation of self-inspection concerning the management of narcotics and psychotropics at PT Kimia Farma Trading & Distribution (KFTD) Bogor Branch in February 2024, based on the self-inspection document FORM/LOG/QA/077. The self-inspection aims to ensure compliance with regulations aligned with GDP standards to guarantee the safety, efficacy, and quality of medicines. Methods included observations, interviews, and analysis of documents and Standard Operating Procedures (SOPs) related to procurement, storage, distribution, and documentation. The evaluation revealed that KFTD Bogor meets the standards set by the National Agency of Drug and Food Control (BPOM). The management of narcotics and psychotropics is conducted systematically and adheres to regulations, including access control, segregated storage, and orderly documentation. However, the self-inspection form requires prior auditing, and improvements such as implementing alphabetical storage are suggested to enhance management efficiency. In conclusion, the self-inspection was effectively executed, demonstrating a high level of regulatory compliance and ensuring safe and accountable management of narcotics and psychotropics at PT Kimia Farma Trading & Distribution (KFTD) Bogor Branch. "
Depok: Fakultas Farmasi Universitas Indonesia, 2024
PR-pdf
UI - Tugas Akhir Universitas Indonesia Library
Ria Artha Rani
Pharmaceutical disributor is one of the parties distributing pharmaceutical products including Cold Chain Products (CCP). Kimia Farma Trading & Distribution (KFTD) Jakarta 3 Branch is one of the PBFs that distributes CCP to various health care facilities. Therefore, KFTD Jakarta 3 must have a distribution procedure that can guarantee the stability of the distributed CCP. In order to ensure the ability of the distribution process to maintain product stability, it is necessary to validate the CCP distribution process from KFTD Jakarta 3."
Depok: Fakultas Farmasi Universitas Indonesia, 2022
PR-pdf
UI - Tugas Akhir Universitas Indonesia Library