UNDERSTANDING GRADE A, GRADE B, GRADE C & D

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Categories:Industry Dynamic
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Origin:Mecart Cleanrooms
Time of issue:2024-11-19 11:26
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Understanding the GMP requirements and their grades can be challenging at times, especially with different regulatory bodies in other countries. What are the differences between a Grade A, Grade B, Grade C, or Grade D cleanroom environment? This article will cover:

The differences between the grades
Their ISO Class equivalent at rest/in operation
Examples of applications for each GMP grade
Graphic charts (number of airborne particles, etc.)

Regulators such as the FDA in the United States or Health Canada ensure the quality of drug products. They put strict and precise regulations for drug manufacturers in the pharma industry.

The Good Manufacturing Practices (GMP) for manufacturing sterile medicinal products were created to ensure that the drugs are safe and contain the ingredients and amounts they claim. These criteria are intended to reduce the risk of microbiological, particle, and pyrogen contamination.

Also known as the current Good Manufacturing Practices (cGMP), the regulations cover production processes, quality control, packaging, personnel, and GMP facility. This article will focus on the latter, the good manufacturing practices for the cleanroom environment of your GMP Facility.