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GMP Inspection by BPOM Indonesia at PT Kalbio Global Medika

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On 10-12 Aug 2022, PT. Kalbio Global Medika (KGM) was inspected for Good Manufacturing Practices (GMP) by The National Agency of Drug and Food Control (NA-DFC) of Indonesia (BPOM Indonesia). This inspection was performed to fulfill Indonesian NA-DFC (BPOM Indonesia) program to have deep understanding in compliance of GMP regulations of pharmaceutical industries in Indonesia.

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The scope of GMP inspection was Erythropoietin manufacturing facility, Efepoetin alfa manufacturing facility, and Non-betalactam small volume injection manufacturing facility. During inspection, there were onsite facility tour, including but not limited to warehouse, utility area, QC area, production area, and other supporting area, documentations review, discussions.