GMP Cleanroom Classification Standards
2023-12-27
| Introduction to GMP: GMP is the abbreviation for Good Manufacture Practice, which sets mandatory requirements for the rationality of the enterprise's production process, the suitability of production equipment, and the accuracy and standardization of production operations. The latest version of "Good Manufacturing Practice for Drugs (Revised in 2010)" was approved by the Ministry of Health's departmental meeting on October 19, 2010, and is now released, officially implemented from March 1, 2011. |
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GMP is the basic principle of drug production and quality management, applicable to the entire process of drug preparation production and the key processes affecting the quality of finished products in raw material drug production. The vigorous promotion of GMP for drugs is to minimize pollution and cross-contamination during drug production, reduce the occurrence of various errors, and is an important measure to improve drug quality. Currently, the sale of drugs produced in China globally requires manufacturers to comply not only with China's 2010 version of GMP standards but also with international standards such as EU/GMP and FDA-cGMP. GMP does not list in detail the requirements for the design, construction, and testing of biological cleanrooms. Detailed content should refer to relevant GMP implementation guidelines, drug GMP certification inspection and evaluation standards, FED 209E, ISO14644, ISO14698, IEST, international GB/T, and EN1882 standards. GMP does not list in detail the requirements for the design, construction, and testing of biological cleanrooms. Detailed content should refer to relevant GMP implementation guidelines, drug GMP certification inspection and evaluation standards, FED 209E, ISO 14644, ISO14698, IEST, international GB/T, and EN1822 standards. Cleanrooms and pollution control technology are one of the main means of ensuring the successful implementation of GMP. |
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Standards related to biological cleanrooms
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Air Cleanliness The air cleanliness zones in biological cleanrooms are divided into four areas: Grade A - High-risk operation area, which directly affects the operation area, such as tunnel sterilization ovens, aseptic filling, bottle openings, high-pressure sterilization cooling areas, etc., which require 100-level laminar flow and directly affect product quality, called Grade A. Grade B - Indirectly affects the aseptic operation area, the area directly surrounding the Grade A area, such as aseptic filling rooms and high-pressure sterilization cooling rooms. Grade C and D - Transitional clean areas entering the aseptic production area, preparation rooms, changing rooms, and buffer rooms.
Approximate Comparison of Different Standards for Suspended Particle Classification in GMP
Comparison of Air Filter Efficiency Specifications
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