Kata Kunci :
Apoteker, PT. Kalbe Farma, Tbk., CPOB, Pemastian Mutu, Product Quality Review (PQR)
Industri farmasi adalah badan usaha yang memiliki izin dari Menteri Kesehatan untuk melakukan kegiatan pembuatan obat atau bahan obat. Dalam menjamin ketersediaan produk obat di masyarakat, industri farmasi harus mampu menyediakan obat yang berkualitas bagi masyarakat. Obat berkualitas mencakup 3 aspek yaitu khasiat (efficacy), keamanan (safety), dan kenyamanan (acceptability) dalam dosis yang digunakan sesuai tujuan penggunaannya. Untuk memastikan produk obat memenuhi ketiga aspek tersebut, maka terdapat peraturan yang perlu diterapkan di industri farmasi, yaitu ketentuan Cara Pembuatan Obat yang Baik (CPOB). Salah satu aspek yang terdapat dalam CPOB yaitu personalia. Terdapat tiga personil kunci yang berperan penting dalam penerapan prinsip CPOB di industri farmasi yaitu kepala bagian produksi, pengawasan mutu dan manajemen mutu (pemastian mutu). Ketiga personil tersebut hendaklah seorang apoteker yang terdaftar dan terkualifikasi. Praktik Kerja Profesi Apoteker (PKPA) selama 2 bulan dilaksanakan di departemen pemastian mutu, di bagian Product Quality Review (PQR). Bagian PQR bertanggungjawab dalam menyusun sistem untuk melaksanakan dan memeriksa mutu produk dengan melihat trend kualitas produk tahunan (mencakpup kapabilitas, ketangguhan proses dan formula, spesifikasi/parameter produk, stabilita dan waktu kadaluarsa, ada komplain/tidak, bahan awal, bahan pengemas, kualifikasi peralatan dan sarana, dsb) sehingga dapat menjadi acuan untuk langkah-langkah selanjutnya (misal: perbaikan formula, parameter proses, dll).
Pharmacy services is one of the efforts in realizing health for the community that is realized by qualified personnel. Pharmacists are workers who carry out Pharmaceutical Work, consisting of Pharmacists and Pharmaceutical Technical Personnel who have expertise and authority in carrying out pharmaceutical work. Pharmacy is a pharmacy service facility where pharmacy work is carried out by pharmacists, which is one of the pharmacist's professional fields in carrying out their professional duties and responsibilities. Pharmacy services carried out by a pharmacist at the pharmacy, namely management of pharmaceutical preparations, medical devices, and consumable medical materials and clinical pharmacy services. To be able to carry out these tasks, the pharmacist needs to get education and training directly. Pharmacist Professional Work Practice (PKPA) was held for 1 month at Apotek Kimia Farma No. 494, Depok aims to understand the duties and responsibilities of pharmacists in the management of pharmacies, practice pharmacy services, have insight, knowledge, skills, and practical experience to practice pharmacy at the pharmacy, and have a real picture of the problems of pharmaceutical practices and learn strategies and activities that can be done in order to develop pharmaceutical practices.
Pharmaceutical Wholesalers are companies in the form of legal entities that have permits for the procurement, storage, distribution of drugs and / or medicinal materials in large quantities in accordance with statutory provisions. PBF in carrying out the procurement, storage and distribution of drugs and / or medicinal ingredients must implement the Technical Guidelines for Good Distribution Practice (GDP). Good Distribution Practice (GDP) is a method of distribution or distribution of drugs and / or medicinal ingredients aimed at ensuring quality along the distribution channels according to the requirements and purposes of their use. Pharmacists as the person in charge of PBF must meet the qualifications and competencies in accordance with the laws and regulations and have knowledge and have taken GDP training. Pharmacist Professional Work Practices carried out at PT. Kimia Farma Trading & Distribution Bandung for 2 weeks with the aim of increasing knowledge and skills in conducting pharmaceutical practices at PBF and knowing the roles and functions of Pharmacists in pharmaceutical work, especially in pharmaceutical services at PBF.