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    Persyaratan Pemeriksaan Sarana Oleh Bpom

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    julian npwp
    This document outlines the requirements and inspection of facilities by the Indonesian Food and Drug Authority for warehouses storing imported traditional medicines or health supplements. It lists the required administrative documents, standard operating procedures and forms, as well as mandatory facilities and tools that must be present in the warehouse, with translations between Bahasa Indonesia and English. Administrative documents include layout drawings, location maps, notarial deeds, taxpayer IDs, and business licenses. Standard operating procedures cover employee hygiene, cleaning, receiving/storage, procurement/distribution, quality control, temperature monitoring, recalls, complaints, returns, and pest management. Mandatory facilities are thermohygrometers, plastic pallets, receiving/sending areas, rejection areas, mousetraps,

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    Persyaratan Pemeriksaan Sarana Oleh Bpom

    Uploaded by

    julian npwp
    19 views2 pages
    This document outlines the requirements and inspection of facilities by the Indonesian Food and Drug Authority for warehouses storing imported traditional medicines or health supplements. It lists the required administrative documents, standard operating procedures and forms, as well as mandatory facilities and tools that must be present in the warehouse, with translations between Bahasa Indonesia and English. Administrative documents include layout drawings, location maps, notarial deeds, taxpayer IDs, and business licenses. Standard operating procedures cover employee hygiene, cleaning, receiving/storage, procurement/distribution, quality control, temperature monitoring, recalls, complaints, returns, and pest management. Mandatory facilities are thermohygrometers, plastic pallets, receiving/sending areas, rejection areas, mousetraps,

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    PERSYARATAN PEMERIKSAAN SARANA OLEH BPOM

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    This document outlines the requirements and inspection of facilities by the Indonesian Food and Drug Authority for warehouses storing imported traditional medicines or health supplements. It lists the required administrative documents, standard operating procedures and forms, as well as mandatory facilities and tools that must be present in the warehouse, with translations between Bahasa Indonesia and English. Administrative documents include layout drawings, location maps, notarial deeds, taxpayer IDs, and business licenses. Standard operating procedures cover employee hygiene, cleaning, receiving/storage, procurement/distribution, quality control, temperature monitoring, recalls, complaints, returns, and pest management. Mandatory facilities are thermohygrometers, plastic pallets, receiving/sending areas, rejection areas, mousetraps,

    Copyright:

    © All Rights Reserved
    Download as DOCX, PDF, TXT or read online from Scribd
    Download as docx, pdf, or txt
    19 views2 pages

    Persyaratan Pemeriksaan Sarana Oleh Bpom

    Uploaded by

    julian npwp
    This document outlines the requirements and inspection of facilities by the Indonesian Food and Drug Authority for warehouses storing imported traditional medicines or health supplements. It lists the required administrative documents, standard operating procedures and forms, as well as mandatory facilities and tools that must be present in the warehouse, with translations between Bahasa Indonesia and English. Administrative documents include layout drawings, location maps, notarial deeds, taxpayer IDs, and business licenses. Standard operating procedures cover employee hygiene, cleaning, receiving/storage, procurement/distribution, quality control, temperature monitoring, recalls, complaints, returns, and pest management. Mandatory facilities are thermohygrometers, plastic pallets, receiving/sending areas, rejection areas, mousetraps,

    Copyright:

    © All Rights Reserved
    Download as DOCX, PDF, TXT or read online from Scribd
    Download as docx, pdf, or txt
    of 2

    PERSYARATAN PEMERIKSAAN SARANA OLEH BALAI POM

    GUDANG OBAT TRADISIONAL IMPOR / SUPLEMEN KESEHATAN


    REQUIREMENTS AND INSPECTION OF FACILITIES BY THE INDONESIAN FOOD AND DRUG AUTHORITY –
    WAREHOUSE FOR IMPORTED TRADITIONAL MEDICINES / HEALTH SUPPLEMENT

    DOKUMEN ADMINISTRASI ( ADMINISTRATIVE DOCUMENT)


    No. Bahasa Indonesia No. In English
    1. Lay out gudang dan kantor ( diatas tengah 1. Building and Office layout (Address and
    ditulis nama perusahaan dan alamat Company name should be center above)
    perusahaan ) dan dibawah ujung kanan and on the lower right corner should be
    tertulis Mengetahui Pimpinan dan dibawah Head of Company and on the lower left
    ujung kiri tertulis Tim Pemeriksa. corner The inspection Team
    ( konsultan )
    2 Peta lokasi ( seperti peta lokasi undangan 2. Location map (for example wedding
    pernikahan , jangan dari google map ) ceremony map. Google map is not allowed)
    ( konsultan )
    3. Akte Notaris 3. Notarial Deed
    4. NPWP ( No Pokok Wajib Pajak ) 4. Company taxpayer identification number
    Perusahaan
    5. NIB ( Nomor Izin Berusaha ) tercantum 5. Business Identification Number
    KBLI 46492 Perdagangan Besar Farmasi KBLI 46492
    ( Suplemen Kesehatan / Obat Tradisional )
    6. GMP tidak perlu dilegalisir 6. Good Manufacturing Practice does not need
    to be legalized kbri
    7. Surat Penunjukkan dari produsen 7. Letter of Appointment from produsen

    8. CFS/CPP Legalisir KBRI 8. Certificate of Free Sale / Certficate of


    Atau list rencana produk yang akan Pharmaceutical Product Legalized KBRI
    diimpor, kops surat ttd direktur cap
    perusahaan

    STANDAR OPERASIONAL PROSEDUR DAN FORMULIR (STANDARD OPERATING PROCEDURES AND


    FORMS) ( All SOP Konsultan )
    No. Bahasa Indonesia No. In English
    1. SOP Hygiene Karyawan 1. Standard Operating Procedure of
    Employees hygiene
    2. SOP Pembersihan Ruangan 2. Standard Operating Procedure of Space
    Cleaning
    3. SOP Penerimaan dan Penyimpanan Barang 3. Standard Operating Procedure of Receipt
    and Storage
    4. SOP Pengadaan dan Pendistribusian Barang 4. Standard Operating Procedure of
    Procurement and Distribution
    5. SOP Pengawasan Mutu Barang 5. Standard Operating Procedure of Quality
    Control
    6. SOP Monitoring Suhu 6. Standard Operating Procedure of
    Temperature Monitoring
    7. SOP Recall 7. Standard Operating Procedure of Recall
    8. SOP Penanganan Keluhan 8. Standard Operating Procedure of Complaint
    Handling
    9. SOP Penanganan Produk Kembalian 9. Standard Operating Procedure of Handling
    of Returned product
    10. SOP Penanganan Hama 10. Standard Operating Procedure of Pest
    Management
    11. Formulir Kebersihan Ruangan 11. Rooms Hygiene form
    12. Formulir Monitoring Suhu 12. Temperature Monitoring form
    13. Kartu Stok 13. Stock Card
    ALAT / FASILITAS YANG HARUS ADA DIGUDANG ( MANDATORY FACILITY / TOOLS IN THE
    WAREHOUSE)
    No. Bahasa Indonesia No. In English
    1. Thermohygrometer ( sudah dikalibrasi ) 1. Thermohygrometer (calibrated)
    2. Palet plastik 2. Plastic pallets
    3. Area Penerimaan dan Area Pengiriman 3. Receiving and sending areas
    4. Area Reject berupa kerangkeng besi / 4. Rejection Area (with iron cage)
    lemari terkunci
    5. Perangkap tikus 5. Mousetrap
    6. Catch Flyer 6. Flytrap
    7. Tempat Sampah Tertutup 7. Closed trash can
    8. APAR ( Alat Pemadam Api Ringan ) 8. Fire Extinguisher
    9. Tulisan ( konsultan ) 9. Warning board
    - dilarang merokok - No Smoking
    - makan dan minum diarea gudang . - No Food and Beverages in
    warehouse
    - Cucilah tangan sebelum dan sesudah - Wash your hands before and after
    bekerja working

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