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ABSTRAKDalam rangka menjamin kualitas produk obat, industri farmasi harus menerapkan Cara
Pembuatan Obat yang Baik (CPOB). CPOB merupakan pedoman yang memiliki tujuan
untuk memastikan agar mutu obat yang dihasilkan sesuai persyaratan dan tujuan
penggunaannya. Apoteker memiliki peran dalam memastikan mutu, keamanan, dan
khasiat obat berdasarkan pedoman CPOB. Oleh karena itu, calon apoteker melakukan
Praktek Kerja Profesi Apoteker (PKPA) agar mengeri peranan, tugas dan tanggung jawab
apoteker di Industri Farmasi, memiliki wawasan, pengetahuan, keterampilan, dan
pengalaman praktis untuk melakukan pekerjaan kefarmasian di Industri Farmasi,
memahami penerapan GMP (CPOB) di Industri Farmasi. PKPA dilaksanakan di
PT.Bayer Indonesia Cimanggis, Depok. Berdasarkan hasil PKPA di PT. Bayer Indonesia
Cimanggis, dapat disimpulkan apoteker di Industri Farmasi memiliki tugas dan tanggung
jawab untuk memastikan mutu, keamanan, dan khasiat obat berdasarkan pedoman CPOB,
mahasiswa mendapatkan tambahan wawasan dan pengetahuan diantaranya meliputi
penerapan data integrity, sistem dokumentasi, pemastian mutu, manajemen supplier,
country quality, studi stabilitas, pengelolaan warehouse, pengelolaan limbah, change
management, engineering dalam industri farmasi, dan manajemen rantai distribusi.
Penerapan aspek pedoman CPOB PT. Bayer Indonesia dideskripsikan dalam bentuk
Standar Prosedur Operasional agar segala kegiatan yang dilakukan oleh setiap personil
sesuai standar pedoman CPOB.
ABSTRACTIn order to guarantee the quality of pharmaceutical products, the pharmaceutical industry
must implement a Good Manufacturing Practices. GMP is a guideline that aims to ensure
that the quality of the drugs produced is according to the requirements and objectives of
their use. GMP covers all aspects of production and quality control. Pharmacists have a
role in ensuring the quality, safety and efficacy of drugs based on GMP guidelines.
Therefore, pharmacist students carry out Apothecary Profession Internship (PKPA) in
order to understand the role, duties and responsibilities of pharmacists in the
Pharmaceutical Industry, have insight, knowledge, skills, and practical experience to do
pharmaceutical work in the Pharmaceutical Industry, understand the application of GMP
in 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 be
concluded that pharmacists in the Pharmaceutical Industry have duties and
responsibilities to ensure the quality, safety and efficacy of drugs based on GMP
guidelines, 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 form
of Standard Operating Procedure so that all activities carried out by each personnel are in
accordance with GMP guideline standards."
