Langkah-Langkah Strategis Apoteker Penanggung Jawab dalam Persiapan Operasional Gudang Baru Pedagang Besar Farmasi (PBF) pada PT Ceria Jaya Farma Berdasarkan Standar CDOB

PT Ceria Jaya Farma has recently expanded its logistics capacity by adding a new pharmaceutical warehouse. As an authorized distribution facility, the new warehouse must strictly comply with legal and technical standards defined by Good Distribution Practice (GDP / CDOB). The Responsible Pharmacist (APJ) plays a critical role as the quality assurance leader to ensure that all infrastructure and systems are operational. This case study article aims to delineate comprehensive and systematic steps required by the APJ prior to warehouse commercial operation. These encompass 6 primary dimensions: evaluation of building and facility conformance, qualification and thermal temperature mapping, establishment of a quality system through Standard Operating Procedures (SOPs), organization of documentation and data recording systems, personnel competency reinforcement, and a final pre-operational self-audit. The methodology involves a contextual analysis of the Indonesian FDA (Badan POM RI) regulations and their practical deployment within PT Ceria Jaya Farma's corporate operations. The analysis indicates that fulfilling these 6 technical steps effectively mitigates the risk of product degradation during distribution, while ensuring a successful regulatory inspection for the official issuance of the GDP certificate addendum.