Cara Pembuatan Obat Baik (CPOB) - PRODUKSI // Kelompok 11 PKLI 2021 Farmasi UIN Malang
Summary
TLDRThis video script introduces the pharmaceutical industry production process in compliance with Good Practice of Operating Procedures (CPoB). It covers the steps from weighing ingredients, mixing, and controlling machinery to ensure quality standards. The script highlights the importance of in-process controls, such as checking for uniformity in weight and hardness of tablets, and organoleptic tests for syrups and semisolids. It also explains packaging processes, including primary and secondary packaging to prevent damage during distribution, and the final storage of products in the warehouse. The presentation concludes with a reminder of the significance of understanding the production process in the pharmaceutical industry.
Takeaways
- 😀 The video is an introduction to the pharmaceutical industry production process by a group called Marina.
- 🔍 The group members introduce themselves, emphasizing the importance of following established procedures and meeting CPoB (Good Production Practice) standards.
- 📋 The script outlines the detailed steps of pharmaceutical production, starting from the weighing of ingredients to the preparation of mixing tanks.
- 🌡️ Temperature and pressure checks are crucial for ensuring the correct conditions during the mixing and production process.
- 💊 The production includes the use of capsule printing machines and tablet printing processes, which require careful control and monitoring.
- 🔨 Quality control is emphasized through in-process checks (IPC), including weight uniformity and content uniformity tests for both capsules and tablets.
- 🏷️ Labeling is an essential part of the process, which must contain specific information such as the name, code, batch number, material status, and expiration date.
- 🧪 Various tests are conducted to ensure product quality, including hardness tests for tablets, and pH and organoleptic tests for syrups and semisolids.
- 📦 Packaging is a critical step, involving primary packaging that comes into direct contact with the product and secondary packaging to prevent damage during distribution.
- 📝 The script mentions the importance of counting and weighing tablets, as well as affixing labels to the cardboard boxes before final storage in the warehouse.
- 👋 The video concludes with a thank you message and a sign-off in Arabic, indicating cultural respect and a formal end to the presentation.
Q & A
What is the main topic of the video?
-The main topic of the video is the production process in the pharmaceutical industry, specifically following the Good Practice of Operation (GPO) standards.
Who are the members of Group 11 presenting the video?
-The members of Group 11 are Monica, Aulia, Not mentioned, Nadia, and Aryanti Lestari.
What are the three main principles of production mentioned in the script?
-The three main principles of production mentioned are following the set procedures, meeting GPO regulations, and fulfilling quality requirements.
What is the first step in the production process described in the script?
-The first step in the production process is the personnel entering the weighing room to prepare and weigh the ingredients.
What is the purpose of the mixing tank in the production process?
-The mixing tank is used to combine all the weighed ingredients for the production of the pharmaceutical product.
What is the importance of temperature control in the production process?
-Temperature control is crucial to ensure the proper mixing and preparation of the ingredients, as well as to maintain the quality of the final product.
What is the role of the capsule filling machine in the production process?
-The capsule filling machine is used to fill the capsules with the mixed ingredients, ensuring the correct dosage and consistency.
Why is it important to store the capsule shells in a certain condition?
-The capsule shells must be stored in a condition that prevents them from drying out and becoming brittle, which could be caused by humidity or other environmental factors.
What is the purpose of In-Process Control (IPC) in tablet production?
-The purpose of IPC is to ensure the quality of the tablets by checking for uniformity in weight and other quality control measures during the production process.
What are the components of labeling for the syrup product mentioned in the script?
-The components of labeling for the syrup product should include the name and code number of the ingredient, batch number, status of the material, and the expiry date or testing date of the material.
What are the packaging steps described for the final product?
-The packaging steps include primary packaging that comes into direct contact with the product, secondary packaging to prevent damage during distribution, strip packaging, cutting, and counting the tablets, followed by placing the product into a box and storing it in the warehouse.
Outlines
😀 Introduction to Pharmaceutical Production Process
This paragraph introduces the video script, which is about demonstrating the pharmaceutical industry production process in accordance with Good Practice of Pharmaceutical Operations (cGMP). The team from group 11, also known as Marina, starts with a self-introduction of its members: Monica, Aulia, Nadia, and Aryanti. They then invite the viewers to watch the video to understand the principles of production, which include following established procedures, meeting cGMP requirements, and fulfilling quality standards, licensing for production, and distribution.
Mindmap
Keywords
💡Production
💡CPoB
💡Quality Control
💡Mixing Tank
💡Temperature Control
💡Capsule Filling Machine
💡Tablet Pressing
💡In-Process Control (IPC)
💡Packaging
💡Expiration Date
💡Organoleptic Testing
Highlights
Introduction to the group 11 and their presentation on pharmaceutical industry production according to CPoB.
Self-introduction of the group members: Monica, Aulia, Nadia, and Aryanti.
Explanation of the principles of production, including adherence to established procedures, meeting CPoB regulations, and quality requirements.
Process of entering the weighing room and preparing materials for weighing.
Machine control and pressure checks for the weighing room environment.
Preparation of the mixing tank and combining all materials.
Adjustment and checking of the temperature for the mixing room.
Temperature checks for the product to ensure readiness for mixing.
Control of the capsule printing machine and the capsule production process.
Storage conditions for the capsule shells to prevent drying and brittleness.
Collection of tablets for the tablet printing process and IPC checks.
Uniformity checks for the weight of tablets and capsules to avoid contamination.
Machine inspection to ensure no leftover materials.
Syrup production process including labeling with necessary information.
In-process control to ensure product quality with various tests for tablets and syrups.
Packaging process including primary and secondary packaging to prevent damage during distribution.
Counting and checking of tablets before packaging them into strips.
Final storage of the products in the warehouse as part of the warehouse's responsibilities.
Closing remarks and thanks for watching, with a sign-off in Arabic.
Transcripts
Hai
rezeki
[Musik]
Assalamualaikum Hai Hai
kami dari kelompok 11 alias Marina akan
menunjukkan cara Produksi Industri
Farmasi sesuai dengan cpob sebelum itu
Yuk kita kenalan terlebih dahulu dimulai
dari aku ya
hanyoung namaku Monica
Hai aku Aulia Hello nama saya tidak
Hello friends are my hand
Hai namaku Nadia Halo saya Aryanti
Lestari Oke Langsung saja yuk mari kita
simak videonya cekidot
kalian tahu enggak sih apa aja prinsip
produksi jadi yang cuma Yaitu mengikuti
prosedur yang telah ditetapkan yang
kedua memenuhi ketentuan cpob yang
memenuhi persyaratan mutu yang ketiga
memenuhi ketentuan izin pembuatan dan
izin edar
nah Mari kita masuk ke bagian intinya
yaitu alur produksi cara pembuatan obat
baik salah satu personel industri
memasuki ruang penimbangan untuk
menyiapkan bahan yang akan ditimbang dan
melakukan penimbangan
Setelah itu dilakukan pengontrolan mesin
dan mengecek tekanan untuk kontrol
ruangan bahan yang sudah ditimbang
lalu disiapkan tangki pencampuran untuk
semua bahan dan disatukan pada tangki
bagian bawah tempat untuk mengeluarkan
produk sampai benar-benar tepat
setelah itu diatur suhu dan dicek suhu
untuk ruangan campurkan lalu dilakukan
pengecekan suhu untuk produk jika semua
bahan sudah siap bahan dicampur di alat
pencampuran personel tersebut melakukan
pengontrolan pada mesin pencetakan
kapsul lalu mesin mulai berjalan untuk
mencetak kapsul tersebut
saat pengisian kapsul cangkang kapsul
hendaklah disimpan dalam kondisi yang
dapat mencegah kekeringan dan kerapuhan
atau efek lain yang disebabkan oleh
kelembaban
Oke selanjutnya kita masuk ke proses
pencetakan tablet pada proses ini
personil melakukan pengumpulan tablet
untuk selanjutnya dilakukan IPC atau
impresses kontrol dan membuat tablet
untuk dilakukan pengecekan yaitu
menghitung keseragaman bobot nya pada
pembuatan tablet dan kapsul usahakan
hindari penggunaan alat gelas untuk
mencegah terjadinya kontaminasi
dan lakukan pengecekan mesin untuk
memastikan ada atau tidak adanya sediaan
yang tertinggal
lalu kita masuk ke bagian proses
pengisian bahan tweet Nah berikut adalah
produk sirup yang akan dilakukan
pelabelan
untuk pelabelan sendiri setidaknya harus
berisi yang pertama nama dan nomor kode
bahan
yang kedua yaitu nomor bets yang ketiga
yaitu status bahan
yang keempat yaitu tanggal kadaluarsa
atau tanggal uji dari bahan tersebut
kemudian dilakukan in process control
untuk memastikan kualitasnya sesuai pada
tablet dilakukan uji keregasan kadar zat
aktif keseragaman bobot dan kecepatan
disolusi untuk sirup dan semisolid
dilakukan uji volume pH dan organoleptis
dilanjutkan dengan pengemasan produk
pengemasan produk meliputi kemasan
primer yang kontak langsung dengan
produk dan kemasan sekunder yang
mencegah kerusakan saat distribusi obat
dilakukan pengemasan strip dan
memotongnya untuk beberapa bagian
setelah itu melakukan pengecekan dan
penghitungan tablet tersebut
selanjutnya memasukkan obat tersebut ke
dalam dusnya
penimbangan tablet
di sini ada yang menimbang tablet dan
juga ada yang menempelkan lem pada
kardusnya setelah selesai semuanya
produk disimpan di dalam gudang Dan ini
juga adalah tugas gudang yang ada di
perusahaan Pabrik industri
nah gimana nih udah paham belum tentang
produksi di Farmasi pasti udah paham
dong Oke kalau gitu Sekian dari kami
Terima kasih sudah menonton
wassalamu'alaikum
warahmatullahi wabarakatuh bye bye
[Musik]
hai hai
Посмотреть больше похожих видео
5.0 / 5 (0 votes)