CPOB EDISI 2006 PDF

12 tahun 3 Keputusan kepala badan pengawas obat sesuai dengan Cara Pembuatan Obat yang bai (CPOB), dan catatan batchnya harus dilaporkan. On a Daily basis the following nine numbers , , , , , , and 12, are used by HVAC engineers and designers as constants . CPOB Edisi Desain darl tala letak ruang hendaklah mernastikan: temperature, humidity and ventilation should be appropriate and such that they do not.

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Published on Nov View Download 4. Zat aktif sulit untuk langsung digunakan krn. Petrolatum Vaseline white, yellow Water-soluble base: Polyethylenglycol PEG – ointment syn. The “c” stands for “current,” reminding manufacturers that they must employ technologies and systems which are up-to-date in order to comply with the regulation.

CPOB Liquid dan Semi Solid

Systems and equipment used to prevent contamination, mix-ups, and errors, which may have been “top-of-the-line” 20 years ago, may be less than adequate by today’s standards. Many countries have not developed local requirements and rely on the World Health Organization Good Manufacturing Practices for Pharmaceutical Prodducts.

Regional requirements have also appeared with application to several countries. Examples of these inciude: Bagaimana membuat sediaan farmasi yang bermutu baik? Melakukan pengawasan selama proses produksi3. Melakukan pengujian terhadap produkjadi4.

A medicine that contains little or none of the claimed ingredient will not have the intended therapeutic effect. Quality vs GMPA basic principle of GMP is ecisi quality cannot be tested into a batch of product but must be built into each batch of product during all stages of the manufacturing process.

It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product. Some of the main risks areunexpected contamination of products, causing damage to health or even death. Pengertian kontaminasiKontaminasi adalah masuknya pengotor atau impurities yang dapat berupa bahan kimia, mikroba dan partikel asing kedalam bahan awal atau produk antaraKontaminasi dapat terjadi selama proses produksi, pengambilan contoh, pengepakan, penyimpanan atau transport.

TeguranPenarikan kembali obat yangberedar recall Penutupan pabrikPelanggaran terhadap ketentuan CPOB 2 Fpob tersebut dikenakan karena pemerintah bertanggung jawab untuk melindungi kesehatan masyarakat pemakai obat kita.

Hal tersebut sebenarnya merupakan tanggung jawab kita juga. Pelanggaran akan merusak reputasiperusahaan, dan mempengaruhi kelangsungan hidup perusahaan. GMP CoversALL aspects of eedisi from the starting materials, premises and equipment to the training and personal hygiene of staff.

Detailed, written procedures are essential for each process that could affect the quality of the finished product. There must be systems to provide documented proof that correct procedures are consistently followed at each step in the manufacturing process – every time a product is made.

History of GMP and evolution of GMP reflects the cooperation of world regulatory bodies such as WHO and the FDA and the need to ensure these regulations are made available to inspectors and manufacturers to conform to. Waktu penyesuaian pemenuhan CPOB Inspeksi CPOB pertama Pedoman CPOB edisi 2 CPOB untuk produk Darah Produk cpb telah melalui seluruh tahap proses pembuatan obat.

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Telah selesai diolah dan dikemas, siap dipasarkan. Bahan yang telah selesai diolah, tinggal dikemas. Bahan atau campuran bahan yang masih memerlukan tahapan pengolahan lebih lanjut untuk menjadi produk ruahan. Semua bahan baku dan bahan pengemas yang digunakan dalam produksi obat. Bahan baku 1 Semua bahan aktif dan bahan tidak aktif yang digunakan dalam pengolahan obat.

Bahan yang memiliki efek langsung terhadap tubuh. Bahan yang memiliki khasiat. Bahan baku 2 Bahan baku tidak aktif: Bahan yang tidak memiliki efek langsung terhadap tubuh pasien.

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Tidak memiliki khasiat, digunakan untuk membantu formulasi. Air dan gula untuk pemanis sirup. Bahan pengemas 1 Bahan pengemas: Semua bahan yang digunakan untuk mengemas produk. Untuk memudahkan distribusi produk dan untuk melindungi produk dari pengaruh lingkungan. Bahan pengemas primerBahan pengemas sekunderBahan pengemas 2 Bahan pengemas primer: Bahan pengemas yang berkontak langsung dengan produkalufoil, blister, botol, vial dan ampulKarena berkontak langsung dengan produk, proses pengemasan primer harus dilakukan di area pengolahan, tidak boleh dilakukan di area pengepakan.

Bahan pengemas 3 Bahan pengemas sekunder: Bahan pengemas yang tidak berkontak langsung dengan produk. Unit box, dus, corrugated boxProses pengemasan sekunder harus dilakukan di area pengepakan, tidak boleh di area pengolahanBatch 1 Sejumlah tertentu obat yang memiliki sifat dan mutu yang seragam. Dibuat atas satu perintah produksi: COADiolah dalam satu siklus pengolahan: Perlu didukung dengan alasan yang jelas, dan pembuktian bahwa tidak terjadi penyimpangan mutu, dan stabilitas produkLot 1 Lot: Bagian dari batch yang memiliki sifat dan mutu yang seragam.

Dalam proses pengolahan suatu produk dapat ditemui tahapan yang mengharuskan untuk membagi batch kedalam beberapa bagianMisalnya: Sebelum bagian-bagian batch dapat dicampurkan, harus dipastikan bahwa semua bagian memiliki sifat mutu yang seragamMisal: Bahan baku, bahan pengemas, dan produk jadi. Produksi – Laktam ; non – Laktam: Kelas hitamKelas abu-abuKelas putihKelas ruangan disesuaikan dengan tujuan pemakaiannya.

Kelas-kelas ruangan 2 Pembagian kelas berdasarkan: Jumlah partikel terutama Tingkat kebersihanJumlah mikrobanyaSecara teknis tiap kelas berbeda pada: KonstruksiMaterialSistem pengendalian udaraKelas hitam Pakaian kerjaBaju, celana sepatuTutup kepala, maskerKelas hitam digunakan untuk: Penanganan produk ruahan yang sudah tertutup kemasan primer: Fruang penge-masan sekunderTidak di- tetapkan Tidak di- tetapkan Tidak di- tetapkan Tidak di- tetapkan Ruang pengemasan sekunder tidak berhubungan langsung dengan area luar; untuk memasuki ruang ini disarankan melewati suatu ruang cob udara airlock atau ruang antara ante- room.

Ggudang, tehnik, lab, kantinTidak di- tetapkan Tidak di- tetapkan Tidak exisi tetapkan Tidak di-tetapkan Ruang penyimpanan gudang. In-line mixerDigunakan dalam proses homogenisasi kontinu thd produk bkuantitas besar dalam waktu relatif singkat. It performs the functions of smashing, emulsification, dispersing, homogen, milling and so on. Biological products, vaccine, medicinal ointment, each kind of oral liquidDaily expenses industry: The range of viscosity of the cob compatibilityParticulate sizeFoam characteristics andHazardous environment considerations.

Commonly Used Filling MachinesOverflow liquid filling machines: These are commonly used in small bottle filling operations and the machine is also able to handle liquids with medium viscosity. Servo pump liquid filling machines: These machines are very versatile liquid filling machine capable of filling nearly any type of product that can be pumped.

This specially designed filler machine is edizi to fill liquids of high value and small volume of liquids fills with high accuracy.

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This is the most economical type of liquid filling eidsi for a limited range of applications. Piston liquid filling machines: These machines fpob one of the oldest and most reliable types that are used in the packaging industry. Net weight liquid filling machines: This type of filler is best suited for liquids that are required to fill in bulk quantities.

Liquid Semisolid Filling contd Overflow liquid filling machinesFor liquids with low to medium viscosity. Note that overflow fillers are the machine of choice in handling very foamy products at higher speeds.

Sauces, syrups, light gels and shampoos, foamy cleansers and chemicals, water and other non carbonated aqueous beverages. High performance, easy to clean, easy to operate, expandable at low cost. Offers greatest flexibility at lowest costOverflow liquid filling machinesThe supply side dark blue of a two part nozzzle is used edsii pump product into the container. When the container fills up to the target fill height, the excess product and foam is forced out of the container red arrows via the return side to the original product source tank.

Both thin and thick products, and also very large particulates can all be filled on this machine. Copb creams as well as thick, chunky sauces at pasteurized temperatures can all be filled. Fill size changeovers are practically infinite edixi are instantaneous by computer control.

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Operator setup is greatly simplified. The design also lends itself very well to sanitary applications due to the ease of automatic cleaning.

Servo pump liquid filling machinesServo pump liquid filling machinesThe filler’s master computer independently tracks the rotation of each pump head so that it knows precisely how much product has been delivered.

When the target fill volume is reached, each pump and nozzle is instantly shut off, resulting in high accuracy fills of your valuable products. The computer stores all fill parameters in memory for fast changeovers. Peristaltic filling machinesSpecifically designed for high value, small volume fills at very 20006 accuracy. Suitable for aqueous and other light viscosity products. Pharmaceutical preparations, fragrances, essential oils, reagents, inks, dyes, and specialty chemicals. Fluid path is disposable; easy cleanup and elimination of cross contamination problems.

Peristaltic filling machinesThe peristaltic pump makes intermittent contact on only the outside of the surgical product tubing ddisi that the product only touches the inside of the tubing. The filler’s master computer independently tracks the of rotations of the peristaltic pump head so that it knows precisely how much product has been delivered. When the target fill volume is reached, the pump stops and the remaining product fluid does not drip out due to pipette action.

Gravity Liquid FillingFor liquids with very thin viscosities that do not change with ambient temperature or with batch variation.