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Deiiang™ GMP Standards-Professional cleanroom solutions

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GMP Standards

GMP, which stands for Good Manufacturing Practices, is a system that ensures that manufactured products—such as food, cosmetics, and pharmaceutical goods—are consistently produced and controlled according to set quality standards. Implementing GMP can help cut down on losses and waste, and avoid recalls, fines, and jail time. Overall, it protects both the company and the consumer from negative food safety events.

GMPs examine and cover every aspect of the manufacturing process to guard against any risks that can be catastrophic for products, such as cross-contamination, adulteration, and mislabeling.

Comparison Table GMP/USP/ISO/FED209E 
projectChina GMP/Europe GMP
ISOFED STD
209E
Suspended
particles
P/m3
levelStaticdynamiclevelStaticleveldynamic
≥0.5um≥5μm≥0.5μm≥5μm≥0.5um≥5μm≥0.5um≥5μm
A352020352020M3.535301005222020100
B3520293520002900
--63520291000
C3520002900352000029000M5.5353000100007352000293010000
8.352000029300100000
D352000029000No regulationsNo regulationsM6.535300001000009352000029300100000

Comparison table of ISO grade standards and ventilation times

ISO ClassACH(AIRCHANGE PER HOUR)
ISO 3360-540
ISO 4300-540
ISO 5240-480
ISO 6150-240
ISO 760-90
ISO 85-48

FAQ

  • What processes are regulated by GMP standards for food and drugs?

    Quality management,Sanitation and hygiene,Building and facilities,Equipment,Raw materials,Personnel,Validation and qualification,Complaints,Documentation and recordkeeping,Inspections & quality audits.


  • What is the difference between GMP and cGMP?

    Good Manufacturing Practices (GMP) and current Good Manufacturing Practices (cGMP) are, in most cases, interchangeable. GMP meaning the basic regulation promulgated by the US Food and Drug Administration (FDA) under the authority of the Federal Food, Drug, and Cosmetic Act to ensure that manufacturers are taking proactive steps to guarantee their products are safe and effective. cGMP, on the other hand, was implemented by the FDA to ensure continuous improvement in the approach of manufacturers to product quality. It implies a constant commitment to the highest available quality standards through the use of up-to-date systems and technologies.


  • What are the 5 Main Components of Good Manufacturing Practice?

    2It is paramount to the manufacturing industry to regulate GMP in the workplace to ensure consistent quality and safety of products. The five main components of GMP, commonly referred to as the 5P’s, help organizations comply with strict standards throughout the entire production process.


  • What are the GMP Standards?

    GMP standards are developed to enhance the safety of manufactured products, especially pharmaceutical goods, and to ensure consumers get the highest quality possible. Adherence to GMP standards not only positively impacts the reputation of manufacturing companies but also reduces batch recalls and negative reports from consumers. Below are 4 measures you can follow to uphold GMP standards


  • How to do GMP certification?

    Validation is the documented act of demonstrating instruments, processes, and activities that are regularlyused or done. This is done to check if they function according to expectations. GMP can involve a number ofthings to be validated, but it's good to focus on the following processes:

    • Process validation

    • Cleaning and sanitation validation

    • Computer system validation

    • Analytical method validation


  • How to Comply with Guidelines?

    GMP guidelines and regulations address different issues that can influence the safety and quality of a product. Meeting GMP or cGMP standards helps the organization comply with legislative orders, increase the quality of their products, improve customer satisfaction, increase sales, and earn a profitable return on investment.