Let’s explore the information on what GMP standards are, the concept of GMP-WHO standards, and the current guidelines for good pharmaceutical manufacturing practices according to GMP-WHO.
Presenting the cleanliness levels in GMP, GMP standards in drug production to ensure the safest and highest quality products. Why is the guidance on good pharmaceutical manufacturing practices according to GMP-WHO so important for the development of food and pharmaceutical companies?
The concept of GMP standards, GMP-WHO standards in drug production
GMP standards in drug production or GMP-WHO standards are a system of various standards developed for use in the production process.
What is GMP? GMP is the abbreviation of the English phrase “Good Manufacturing Practice,” a mandatory standard for factories producing, processing, and packaging food, pharmaceuticals,…
The cleanliness levels in GMP aim to control various factors that can affect product quality.
Drug manufacturing plants produce products that have a direct impact on the health of humans and animals.
Therefore, the control of factors affecting food hygiene and safety or good pharmaceutical manufacturing practices is strictly implemented.
Throughout the processing, starting from the design and construction of the factory, the selection and installation of equipment and tools to serve the production process, packaging, preservation, and human factors… all are of absolute importance.
The content of GMP standards in drug production includes the standards specified in the GMP standard document, including:
- Organization of personnel
- Production facilities
- Machinery and equipment
- Documents and records
- Quality control
- Production
- Product complaints and recalls
- Self-inspection.
4 Cleanliness levels in GMP
To achieve clean air, the 4 cleanliness levels in GMP for pharmaceutical plants are A, B, C, D. The number of air changes needs to be appropriate for the room size, equipment, and the number of personnel present. Typically, the number of air changes is as follows:
- Level D: 20 times
- Level C: 30 times
- Level B: 40 times
- Level A: 60 times
HEPA filters must undergo leak tests according to ISO 14644-3 standards, with a recommended frequency of 6-12 months to ensure that the filter material, frame, and internal filter connections are free from leaks.
What is the purpose of GMP-WHO standards?
GMP-WHO standards help ensure that drug products are consistently produced and controlled according to quality standards and are safe for use. GMP standards regulate that factories, facilities, or plants that meet GMP standards must fully comply with construction standards.
- Applying GMP standards in drug production helps prevent hazards caused by contamination (from personnel, factories, machinery, equipment, or production tools to the product).
- Prevent cross-contamination (from products at one stage to products at another stage) or the growth of hazards (mainly biological).
GMP-WHO standards are also a prerequisite for the development of the HACCP (Hazard Analysis and Critical Control Points) system and ISO 22000 food safety management standards.
Although quite strict in its regulations on cleanliness levels in GMP, we can be flexible depending on the company’s conditions. It depends on the production scale and type of operation of each company, and does not completely require strict adherence to the general rules.
What are the benefits of guidelines for good pharmaceutical manufacturing practices according to GMP-WHO?
GMP standards are part of a quality management system to ensure the control of factory infrastructure conditions, human conditions, and the production process to achieve a final product with quality, safety, and hygiene.
- The benefits of guidelines for good pharmaceutical manufacturing practices according to GMP-WHO are to create a scientific and systematic quality management method.
- Reduce the risks and incidents that may occur in production and business.
- Reduce production costs by using the right and sufficient technical equipment necessary for production. Therefore, good pharmaceutical manufacturing practices contribute to avoiding wasted investment capital.
- Elevate the company’s workforce to a new level, making them more professional and responsible.
- Help build trust among customers and regulatory bodies towards companies that effectively implement GMP standards.
- GMP-compliant factories can easily obtain recognition from international organizations. Thereby increasing international competitiveness and expanding business and export opportunities.
Therefore, the World Health Organization recommends the implementation of the GMP-WHO “Good Manufacturing Practice” standards.
GMP standard documents guiding good manufacturing practices:
GMP-WHO standards were issued in 1960 and are applied by pharmaceutical regulators in hundreds of different countries worldwide, mainly in developing countries.
The EU GMP (GMP-EU) law has similar regulations to the GMP-WHO standards and the US Food, Drug, and Cosmetic Act.
In 1996, the ASEAN countries issued a common GMP-ASEAN standard in pharmaceutical and medical production.
In 1996, the ISO Committee issued ISO 15378:2006 – Primary packaging materials for medicinal products – Particular requirements for the application of ISO 9001:2000 and Good Manufacturing Practice (GMP).
To achieve GMP-WHO standards, manufacturers are required to meet the 3Gs:
- GSP (Good Storage Practices)
- GLP (Good Laboratory Practices)
- GMP (Good Manufacturing Practices)
Above is some detailed information about GMP standards in drug production. The application of GMP-WHO standards or good pharmaceutical manufacturing practices will be a favorable condition for business development.
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If you need advice on designing GMP-compliant factories according to the cleanliness levels in GMP or need GMP standard documents, you can contact MIGCO.
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