GMP is an indispensable standard in many manufacturing plants today. GMP factories ensure that the production process is efficient and safest. So what is a GMP WHO-standard factory? What are the requirements and certification procedures? Let’s find out with Viet Sing right now.
What is a GMP-standard factory?
GMP stands for “Good Manufacturing Practice,” understood as the standard for “Good Manufacturing Practice”. The GMP standard is a set of general regulations or guidelines to ensure that manufacturers consistently produce products of registered quality and safety for consumers.
This is considered a mandatory standard for all manufacturing sectors, processing products that require high food safety and sanitation conditions such as pharmaceuticals, food, cosmetics, medical equipment, etc. The aim is to ensure that products consistently meet quality and safety standards.
GMP WHO is the GMP standard issued by the World Health Organization.
A GMP WHO-compliant factory must meet strict requirements regarding infrastructure, supporting facilities, machinery and equipment, personnel and production processes, ensuring a closed-loop system built to standard specifications.
Requirements and conditions for a GMP-standard factory
GMP is considered the strictest regulatory system, encompassing stringent standards that facilities and factories must strictly adhere to.
1. Personnel and GMP Training
Human resources are the most important factor in any organization or business. To comply with GMP standards, employees need to be knowledgeable about it. All individuals involved in the production process must have clear roles and responsibilities. A GMP-compliant factory needs to conduct regular training sessions to enhance the knowledge and skills of its employees.
The way GMP holds manufacturing facilities accountable is through requirements for procedures documented and recorded during the production process. Therefore, all procedures and documents must be clearly presented and compliant with GMP standards.
3. Products and Raw Materials
Both input raw materials and output products are subject to control. Therefore, the specifications and components of the raw materials must be clear at every stage of production. For output products, compliance with packaging procedures, testing and sampling is necessary. Ultimately, all tests and technical specifications of the materials must be documented in the records.
4. Workshop and Equipment
The workshop needs to be spacious, well-ventilated, designed, constructed, maintained and repaired in accordance with the production process. All of these factors positively impact both product quality and the operation of the staff.
All production tools, machinery, lighting, sanitation, etc., must be arranged, designed, structured and adjusted to suit the production process. The layout and design of machinery and equipment should aim to minimize the risk of errors and allow for easy cleaning and maintenance to ensure compliance with standards in the production environment. Particularly, quality checks of equipment need to be conducted before they are put into use.
5. Production Procedures
The system of procedures must be clearly defined, consistent and assessed at various intervals. GMP factories need to have clear guidelines and evaluators must ensure compliance as well as readiness for self-assessment to facilitate new improvements.
Each product type has different processing procedures and these processes yield the greatest efficiency for factories. The production procedures will also be continuously monitored by the supervising staff, aiding GMP-compliant factories in identifying faulty products and risks.
Hygiene, waste disposal, personal items, etc., also require attention. Additionally, the proper handling and storage of harmful chemicals are necessary. Hygiene is among the key factors contributing significantly to maintaining product quality.
Viet Sing’s Understanding of GMP WHO
Understanding and dedicating research to produce clean and safe products for the community has been a cornerstone at Việt Sing. Right from the construction phase of their factory, the co-founders delved into comprehending and establishing a system for manufacturing consumer goods in the paper industry that adheres to the Good Manufacturing Practice (GMP) standards. With a cutting-edge, world-class machinery system and raw materials imported from advanced countries like Japan, the USA and South Korea, they manufacture top-quality products for both domestic and international consumers.
The factory was constructed and implements production procedures according to GMP standards in a positive pressure environment, effectively eliminating dust and expelling bacteria, preventing cross-contamination, thereby creating an ultra-clean environment within the workshop area. Consequently, the products are ensured to be impeccably hygienic and safe.
The production area is solidly built according to CLEAN ROOM standards, equipped with lighting and ventilation systems ensuring sufficient light and ventilation in all areas of the factory.
Viet Sing – WHO GMP Standard Factory – Where Jo Diapers Are Produced in Ultra-Clean Conditions
After personal hygiene procedures, staff and workers entering the workshop pass through an automatic door into an air-blowing chamber, where the airlock operates. Here, a very strong air pressure is generated, continuously spraying for 10 seconds to sweep away dust and disinfect individuals before entering the production workshop. When leaving the factory, operators and workers also pass through a decontamination system – an air-blowing chamber – to assist in eliminating and controlling dust particles on their clothing.
Air treatment system within the workshop: The entire air within the workshop is pumped through an air treatment system that filters out dust and bacteria through a membrane soaked in nano-silver solution. The air is sprayed unidirectionally, entering from one end and exiting from the other, avoiding cross-contamination of dust and bacteria.