GMP, which is short for Good Manufacturing Practices, has long been an important standard in the manufacturing fields, especially pharmaceuticals. Therefore, Pharmaceutical products of good quality on the market must be conformed to the GMP criteria. In Vietnam, a lot of western medicine are also produced following the GMP manufacturing process. To have an overview of the pharma industry in Vietnam, you can read our previous blog in the “Vietnam Pharma market” series. Coming up next, this guide will help you know more about how your products, western medicine, is produced in Vietnam.
Source: Viego Global Team
Step 1. Importing raw material
Medicine is made up of material. Therefore, it has to be preserved carefully throughout the shipping process. To pass this step, the material must not contain toxic chemicals, not be fake or unqualified, and have verified origin. The GMP manufacturing process is started from this very first step.
Step 2. Testing raw material
After finishing step 1, the material would be brought to the test in the laboratory. In this step, all the toxic chemicals will be eliminated. Simultaneously, the manufacturer will check the quality of the material, whether it contains ingredients causing bad side effects when combined together. As a result, the process would be stopped immediately when there are inconsonant ingredients contained due to the law.
Starting on the production line, the tested material will be measured and divided partly. After that, the mixer will mix evenly the material, control micro size and moisture of the material, which is now in flour form.
To assure uniformity, all the parameters, which are volume, spin speed, moisture, micro size, mixing time in the mixing process have to be controlled continuously.
There are many types of mixing equipment, such as the V mixer, Cube mixer, Vacuum mixer. Thus, the use of each type depends on the quantity, procedure method, and type of medicine.
Step 4. Tablets – hard capsules
4.1 Tablets, film cover
After preparation, the medicine in flour form is moved to the pressing machine. As a result, the medicine would be shaped in oval or circle form depending on requirements.
In the entire process, staff must control the process continuously. Especially, they need to check the quality, size, quantity, hardness and note fully in the manufacturing diary. If there is any mistake, they need to adjust immediately.
After pressing, the medicine, which is in solid form, is sprayed with film cover. In addition, this process includes the spraying process, mixing process, and drying process. To assure the medicine has the same quality, parameters must be controlled.
First, in the spraying process, they have to control spaying flow, spraying pressure, spraying angle, and the distance between spaying gun machines to medicine.
Second, in the mixing process, the rotation speed of the machine will be taken into consideration.
Third, in the drying process, they have to control dried airflow, air temperature, and medicine temperature.
4.2 Hard Capsules
With hard capsules, the process is quite simple due to automatic machines. However, the quality of capsules and medicine have to be compatible. Moreover, they should notice some elements of the hard capsules, such as ingredients, moisture, size, water content, moisture absorption.
Step 5. Packaging: Blister, bottle, box
5.1 Blister or bottle
Depending on product registration and business requirement, the medicine can be packaged in blister or in bottles. In other words, if packaged in bottles, the automatic machine can count exactly the quantity and cover the lid. If packaged in blister, they will use the polymer (PVC) – aluminum machine. The machine patterns from flat PVC plates. After that, the medicine is arranged into patterns, and the aluminum will be solder.
The box has to be in accordance with the registered sample. In detail, on the package, the information on medicine boxes must be clear, informative, and accurate for the users to checkup, and search.
Step 6. Testing product quality
This is the last testing product quality. If this process is not passed, the product will not be allowed to be distributed in the market. Additionally, all the products in the previous steps must reach the standard. To pass this step, 100% of the product must be qualified. After that, the product will be stored in accordance with Good Manufacturing Practice (GMP) procedure.
Step 7. Keeping the record, distributing product
This is the last step in the GMP manufacturing process of western medicine in Vietnam. All the documents, data about the whole process of the medicine will be stored. After that, The manufacturer will need to distribute the product in accordance with the contract.
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