Cara Pembuatan Obat Baik (CPOB) - PRODUKSI // Kelompok 11 PKLI 2021 Farmasi UIN Malang

Summary

This 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.