CHAPTER IX DOCUMENTATION
E. OPERATIONS
E.7. Distribution
12.31 The distribution must pay attention to the steps of receiving order, packaging, and shipment.
12.32 Receiving order
a. At the time of receiving order, the distribution facility’s responsible person must examine the following matters:
1) purchase order with special format that has been defined and separate from other pharmaceutical products;
2) authenticity of purchase order, not in the form of facsimile, photocopy, scanned of printed document, or email;
3) the accuracy of purchase order, which include:
a) name and address of the responsible person from customer;
b) name, address and phone number of the distribution facility;
c) nama narkotika, psikotropika, atau prekursor farmasi, jenis dan kekuatan sediaan, isi kemasan dan jumlah dalam bentuk angka dan huruf;
d) nomor surat pesanan;
e) nama, alamat, dan izin sarana pemesan;
f) tanggal surat pesanan.
4) Keabsahan surat pesanan, meliputi:
a) tanda tangan dan nama jelas penanggung jawab;
b) nomor Surat Izin Praktek
Apoteker (SIPA) penanggung jawab;
c) stempel fasilitas distribusi atau sarana pelayanan kefarmasian.
b. Penanggung jawab fasilitas distribusi harus memperhatikan kewajaran jumlah dan frekuensi pesanan serta hal-hal lain yang berpotensi terjadinya diversi.
c. Pesanan yang ditolak atau yang tidak dapat dilayani harus segera
c) name, type and dosage, packaging content and quantity of narcotics, psychotropics, or pharmaceutical
precursors in the form of numbers and letters;
d) purchase order number;
e) name, address, and license of the customer.
f) date of purchase order.
4) validity of purchase order, which include:
a) signature and clear name of the responsible person;
b) number of Pharmacist Practice License (SIPA) of the responsible pharmacist;
c) stamp of the distribution facilities or the pharmaceutical service facilities.
b. The responsible person of the distribution facilities must pay attention to the reasonable quantity and frequency of order, as well as other matters which may lead to potential diversion.
c. Rejected order or one that cannot be accommodated must
diberitahukan kepada pemesan dengan menerbitkan Surat Penolakan Pesanan paling lama 7 (tujuh) hari kerja.
d. Surat pesanan narkotika, psikotropika, atau prekursor farmasi yang dapat dilayani, disahkan oleh penanggung jawab fasilitas distribusi dengan membubuhkan tanda tangan atau paraf atau sistem lain yang dapat dipertanggungjawabkan.
12.33 Pengemasan
a. Pengemasan untuk tujuan
pengiriman narkotika, psikotropika, atau prekursor
farmasi harus dilaksanakan setelah menerima surat pesanan.
b. Setiap pengeluaran narkotika, psikotropika, atau prekursor farmasi untuk dilakukan pengemasan harus dicatat dalam kartu stok dan disahkan dengan paraf Kepala Gudang.
c. Sebelum dilakukan pengemasan narkotika, psikotropika, atau prekursor farmasi yang akan dikirim harus dilakukan pemeriksaan terhadap:
immediately be notified to the customer by issuing a Rejection Order no later than 7 (seven) working days.
d. Purchase order of narcotics, psychotropics, or pharmaceutical precursors that can be served is validated by the responsible person of the distribution facilities by attaching signature or initials or other system that can be accounted.
12.33 Packaging
a. Packaging for shipment of narcotics, psychotropics, or pharmaceutical precursors must be done after there is a Purchasing Order.
b. Any quantity of narcotics, psychotropics, or pharmaceutical precursors that are taken out for packaging must be recorded in the stock card and endorsed by the initials of the Head of Warehouse.
c. Prior to the packaging of narcotics, psychotropics, or pharmaceutical precursors to be delivered, an examination must be done for the following matters:
1) kebenaran nama narkotika, psikotropika, atau prekursor farmasi, jenis dan kekuatan sediaan, isi kemasan dan jumlah;
2) nomor bets, tanggal kedaluwarsa, dan nama industri farmasi;
3) kondisi kemasan termasuk penandaan dan segel dari narkotika, psikotropika, atau prekursor farmasi;
4) kelengkapan dan keabsahan dokumen serta kebenaran tujuan pengiriman.
d. Kepala gudang dan penanggung jawab fasilitas distribusi harus memastikan bahwa pengemasan terhadap narkotika, psikotropika atau prekursor farmasi yang akan dikirim telah dilakukan sesuai butir c yang dibuktikan dengan telah ditandatanganinya faktur penjualan dan/atau Surat Pengiriman Barang.
e. Pengemasan harus dilakukan sedemikian rupa untuk menghindari terjadinya pencurian/ penyalahgunaan selama proses pengiriman.
1) accuracy of name, type and dosage, packaging content and quantity of narcotics,
psychotropics, or pharmaceutical precursors;
2) batch number, expiry date, and name of the pharmaceutical industries;
3) packaging conditions including labeling and seal of
the narcotics, psychotropics, or pharmaceutical precursor;
4) completeness and validity of documents and accuracy of the delivery destination.
d. The Head of Warehouse and the responsible person of the distribution facilities must ensure that the packaging of narcotics, psychotropics, or pharmaceutical precursors for delivery has complied with point c, evidenced by retaining the signed sales invoice and/or shipment Documents.
e. The packaging must be provided securely to avoid theft/ abuse during the shipping process.
12.34 Pengiriman
a. Setiap pengiriman narkotika, psikotropika, atau prekursor farmasi harus disertai dan dilengkapi dengan dokumen
pengiriman narkotika, psikotropika, atau prekursor
farmasi yang sah, antara lain salinan surat pesanan, surat jalan dan/atau surat pengantar/
pengiriman barang dan/atau faktur penjualan yang dikeluarkan oleh fasilitas distribusi yang ditandatangani oleh kepala gudang dan penanggungjawab fasilitas distribusi.
b. Setiap pengiriman Narkotika, Psikotropika, dan Prekursor Farmasi dalam bentuk bahan obat harus disertai dan dilengkapi dengan dokumen sebagaimana disebut pada huruf a) juga disertai dan dilengkapi dengan fotokopi Surat Persetujuan Impor (SPI) dan fotokopi Certificate of Analysis (CoA).
c. Dokumen pengiriman harus terpisah dari dokumen lain.
d. Fasilitas distribusi wajib bertanggung jawab terhadap
12.34 Delivery
a. Each shipment of narcotics, psychotropics, or pharmaceutical precursors must be attached with and equipped by valid shipment documents of narcotics, psychotropics, or pharmaceutical precursors, such as copy of purchase order, delivery note/delivery order and/or sales invoices issued by the distribution facilities, signed by the head of warehouse and the responsible person of the distribution facilities.
b. Each delivery of Narcotics,
Psychotropics, and Pharmaceutical Precursors as
pharmaceutical starting materials must be attached by
and completed with documents as referred to in letter a) also attached by and completed with a photocopy of Import Approval Letter (SPI) and a copy of Certificate of Analysis (CoA).
c. Shipment document must be separated from other documents.
d. Distribution facilities must be responsible for shipment of
pengiriman narkotika, psikotropika, atau prekursor farmasi sampai diterima di tempat pemesan oleh penanggung jawab sarana atau penanggung jawab produksi, dibuktikan dengan telah ditandatanganinya surat pengantar/ pengiriman barang
(nama, nomor SIPA, tanda tangan penanggung jawab, tanggal penerimaan, dan stempel sarana).
e. Penanggung jawab sarana adalah apoteker penanggung jawab di fasilitas pelayanan kefarmasian atau di fasilitas distribusi tujuan pengiriman.
Apabila pada saat pengiriman tidak dapat diterima oleh penanggung jawab, maka narkotika, psikotropika, atau prekursor farmasi dapat diterima oleh apoteker lain yang memiliki SIPA di fasilitas tersebut atau tenaga teknis kefarmasian yang memiliki SIPTTK di sarana tersebut, dan telah mendapat pendelegasian dari apoteker
penanggung jawab.
Pendelegasian dapat dibuktikan dengan dokumen pendelegasian.
narcotics, psychotropics, or pharmaceutical precursors until being received in place by the responsible person for ordering or responsible person for production, as evidenced by the signing of the delivery notes (name, number of letter of permit for pharmacy management/
SIPA, signature of the responsible person, date of receipt, and stamp).
e. Pharmacist in charge of facilities is a pharmacist in charge of a pharmaceutical service facility or distribution facility of the delivery destination. If at the time of delivery, the pharmacist in charge are not present to receive the narcotics, psychotropics, or pharmaceutical precursors, they can be received by other pharmacists who have Pharmacist Practice License (SIPA) at the facility or pharmaceutical technical personnel who have SIPTTK at the facility, and have been delegated in a written document by the pharmacist in charge.
f. Dalam hal pengiriman dilakukan oleh pihak ketiga/ekspedisi maka harus dilengkapi dokumen serah terima antara fasilitas distribusi dengan pihak ketiga/ekspedisi, yang sekurang-kurangnya mencantumkan nama dan alamat perusahaan ekspedisi serta tanda tangan dan nama lengkap petugas ekspedisi yang melakukan serah terima barang.
Dokumen serah terima hendaklah tidak merinci informasi sebagaimana tertera dalam salinan surat pesanan, surat pengiriman barang atau faktur penjualan.
g. Setiap narkotika, psikotropika, atau prekursor farmasi yang mengalami kerusakan dalam pengiriman harus dicatat dalam bentuk berita acara dan dilaporkan segera kepada penanggung jawab fasilitas distribusi pengirim. Selanjutnya hal tersebut dilaporkan kepada Badan POM dengan tembusan Balai Besar/Balai POM setempat.
h. Setiap kehilangan narkotika, psikotropika atau prekursor farmasi selama pengiriman wajib dicatat dalam bentuk berita acara
f. In the event that delivery is carried out by a third party/courier, handover document between the distribution facilities and the third party/courier must be provided, which at least includes the name and address of the delivery company as well as the signature and full name of the expedition officer conducting the handover.
The handover document should not specify the detailed information listed on the copy of the purchasing order, shipment documents, letter or sales invoices.
g. Any narcotics, psychotropics, or pharmaceutical precursors that are damaged during delivery must be recorded in the form of minutes and immediately reported to the responsible person of the supplying distribution facilities. Afterward, it is reported to the Indonesian FDA with a copy to the local Provincial Indonesian FDA.
h. Any loss of narcotics, psychotropics, or pharmaceutical precursors during shipment must be recorded in the form of
dan dilaporkan segera kepada penanggung jawab fasilitas distribusi. Selanjutnya hal tersebut segera dilaporkan kepada Badan POM dengan tembusan Balai Besar / Balai POM setempat dilengkapi dengan Berita Acara kehilangan narkotika, psikotropika, dan/atau prekursor farmasi, hasil investigasi internal yang dilakukan fasilitas distribusi, dan bukti lapor kepolisian.