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Introduction to GMP and Clean Room

Introduction to GMP

GMP is the English abbreviation of Good Manufacture Practice (GMP). It sets mandatory requirements for the rationality of the enterprise's production process, the applicability of the production equipment, and the accuracy and standardization of the production operation. The latest version of the "Good Manufacturing Practice for Pharmaceuticals (2010 Revision)" was reviewed and approved by the Ministry of Health at the executive meeting on October 19, 2010. It is now released and will be officially implemented on March 1, 2011.

GMP is the basic guideline for pharmaceutical production and quality management. It applies to the entire process of pharmaceutical preparation production and the key processes that affect the quality of finished products in the production of raw materials. Vigorously promoting pharmaceutical GMP is to avoid contamination and cross-contamination in the pharmaceutical production process to the greatest extent, and to reduce the occurrence of various errors. It is an important measure to improve pharmaceutical quality.

Currently, the global sales of pharmaceuticals produced in China require manufacturers not only to comply with China's 2010 version of GMP specifications but also to comply with the requirements of the international standard EUIGM FDA-cGMP.

GMP does not list in detail the requirements for the design, construction, and testing of biological clean rooms. For details, please also refer to relevant GMP implementation guidelines, pharmaceutical GMP certification inspection and evaluation standards, FED 209E, ISO14644, ISO14698, IEST, and international GBT. EN1822 and other standards.

Clean room and pollution control technology are one of the main means to ensure the successful implementation of GMP.

Related standards for biological clean rooms

Air cleanliness

The air clean area of the biological clean room is divided into four areas:

Level A - high-risk operation area, that is, the area that directly affects the operation. Level 100 laminar flow is required for tunnel sterilization ovens, aseptic filling, bottle openings, high-pressure sterilization cooling areas, etc. It directly affects product quality and is called Grade A.

Level B - places that indirectly affect the aseptic operating area and directly surround the level A area, such as aseptic filling rooms, high-pressure

Sterilize and cool the room.

Levels C and D - Transitional clean areas entering the sterile production area. Prep room, changing room, and buffer room.