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

Monika Arzela

20 Aug 202105:06

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

00:00

😀 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

Production refers to the process of creating goods or services, often involving several stages of manufacturing. In the context of the video, it specifically pertains to pharmaceutical production, which is the systematic process of creating medicinal products. The script mentions various steps involved in production, such as weighing ingredients, mixing, and packaging, which are all integral to the pharmaceutical industry's manufacturing process.

💡CPoB

CPoB stands for 'Certificate of Pharmaceutical Product', which is a document issued by the regulatory authority of a country to verify the details of a pharmaceutical product. The script emphasizes the importance of adhering to CPoB standards, indicating that the production process must meet certain quality and regulatory requirements to ensure the safety and efficacy of the pharmaceutical products.

💡Quality Control

Quality Control (QC) is the process of ensuring that the pharmaceutical product meets the required standards of quality. The script describes various checks and balances in the production process, such as in-process control (IPC) and uniformity of dosage, which are part of the QC measures to maintain the integrity and consistency of the final product.

💡Mixing Tank

A mixing tank is a vessel used in the pharmaceutical industry to combine raw materials. The script mentions the preparation of a mixing tank for all ingredients, highlighting the importance of this equipment in the blending phase of pharmaceutical production where ingredients are combined to create the final product.

💡Temperature Control

Temperature control is crucial in pharmaceutical production to ensure the stability and effectiveness of the product. The script refers to checking the temperature for the mixing room and the product, indicating the need for precise environmental conditions to maintain the quality of the pharmaceuticals during production.

💡Capsule Filling Machine

A capsule filling machine is used to fill capsules with the pharmaceutical product. The script describes the operation of this machine, emphasizing the role of personnel in controlling the machine to ensure the correct filling of capsules, which is a critical step in the production of capsule-based medications.

💡Tablet Pressing

Tablet pressing is the process of forming powder or granules into tablets using a tablet press machine. The script mentions this process, indicating that after the ingredients are mixed, they are often formed into tablets, which is a common form of pharmaceutical dosage.

💡In-Process Control (IPC)

In-Process Control (IPC) refers to the checks performed during the production process to ensure that the product is being manufactured according to the required standards. The script mentions IPC in the context of tablet production, where checks such as hardness and content uniformity are performed to maintain quality.

💡Packaging

Packaging in the pharmaceutical industry involves enclosing the product in a container to protect it and provide information about it. The script describes the packaging process, including primary packaging that comes into direct contact with the product and secondary packaging that protects it during distribution.

💡Expiration Date

The expiration date is the date until which the pharmaceutical product is expected to remain effective. The script mentions the importance of including the expiration date on the label, which is crucial for consumers to know the shelf life of the medication.

💡Organoleptic Testing

Organoleptic testing is a method of evaluating the sensory properties of a pharmaceutical product, such as taste, smell, and appearance. The script refers to this type of testing for semisolid products like syrups, which is an important part of ensuring the product meets the required quality standards.

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.