ABSTRAK
Dalam rangka menjamin kualitas produk obat, industri farmasi harus menerapkan CaraPembuatan Obat yang Baik (CPOB). CPOB merupakan pedoman yang memiliki tujuanuntuk memastikan agar mutu obat yang dihasilkan sesuai persyaratan dan tujuanpenggunaannya. Apoteker memiliki peran dalam memastikan mutu, keamanan, dankhasiat obat berdasarkan pedoman CPOB. Oleh karena itu, calon apoteker melakukanPraktek Kerja Profesi Apoteker (PKPA) agar mengeri peranan, tugas dan tanggung jawabapoteker di Industri Farmasi, memiliki wawasan, pengetahuan, keterampilan, danpengalaman praktis untuk melakukan pekerjaan kefarmasian di Industri Farmasi,memahami penerapan GMP (CPOB) di Industri Farmasi. PKPA dilaksanakan diPT.Bayer Indonesia Cimanggis, Depok. Berdasarkan hasil PKPA di PT. Bayer IndonesiaCimanggis, dapat disimpulkan apoteker di Industri Farmasi memiliki tugas dan tanggungjawab untuk memastikan mutu, keamanan, dan khasiat obat berdasarkan pedoman CPOB,mahasiswa mendapatkan tambahan wawasan dan pengetahuan diantaranya meliputipenerapan data integrity, sistem dokumentasi, pemastian mutu, manajemen supplier,country quality, studi stabilitas, pengelolaan warehouse, pengelolaan limbah, changemanagement, engineering dalam industri farmasi, dan manajemen rantai distribusi.Penerapan aspek pedoman CPOB PT. Bayer Indonesia dideskripsikan dalam bentukStandar Prosedur Operasional agar segala kegiatan yang dilakukan oleh setiap personilsesuai standar pedoman CPOB.
ABSTRACT
In order to guarantee the quality of pharmaceutical products, the pharmaceutical industrymust implement a Good Manufacturing Practices. GMP is a guideline that aims to ensurethat the quality of the drugs produced is according to the requirements and objectives oftheir use. GMP covers all aspects of production and quality control. Pharmacists have arole in ensuring the quality, safety and efficacy of drugs based on GMP guidelines.Therefore, pharmacist students carry out Apothecary Profession Internship (PKPA) inorder to understand the role, duties and responsibilities of pharmacists in thePharmaceutical Industry, have insight, knowledge, skills, and practical experience to dopharmaceutical work in the Pharmaceutical Industry, understand the application of GMPin the Pharmaceutical Industry. PKPA is carried out at PT.Bayer Indonesia Cimanggis,Depok. Based on the results of PKPA at PT. Bayer Indonesia Cimanggis, it can beconcluded that pharmacists in the Pharmaceutical Industry have duties andresponsibilities to ensure the quality, safety and efficacy of drugs based on GMPguidelines, students get additional insights and knowledge including data integrity,documentation systems, quality assurance, supplier management, country quality,stability studies, warehouse management, waste management, change management,engineering in the pharmaceutical industry, and distribution chain management.Application of aspects of GMP guidelines PT. Bayer Indonesia is described in the formof Standard Operating Procedure so that all activities carried out by each personnel are inaccordance with GMP guideline standards. |
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