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GMP Requirements For Clean Room Of Pharmaceutical Factory Workshop

GMP Requirements For Clean Room Of Pharmaceutical Factory Workshop

2022-06-23

The factory building of a pharmaceutical enterprise is a special kind of building, and it is the largest hardware for implementing the Good Manufacturing Practice (GMP) of pharmaceuticals. The purpose of implementing GMP is to ensure the safety and good quality of drugs. It must involve every link of drug production and control all factors affecting drug quality in the entire production process.

 

Keywords: GMP workshop clean room

GMP is the abbreviation of Good manufacture Practice for Drugs. GMP is a set of scientific management methods and implementation measures to ensure the production of high-quality drugs by using scientific, reasonable and standardized conditions and methods in the whole process of drug production.

 

The purpose of implementing GMP is to enable users to obtain high-quality drugs, but it is not achieved only through final inspection, but to implement scientific whole-process management and strict monitoring in the entire process of drug production to obtain drugs of expected quality.

 

Therefore, GMP requires that pharmaceutical manufacturers must formulate clear guidelines and management methods from the receipt of raw materials to manufacturing, packaging, labeling, delivery and other production steps and operations, and at the same time, through strict production process management and quality management to Carry out proper inspection, monitoring and recording of each of the above-mentioned links.

 

GMP mainly includes the following aspects:

Personnel and institutions, plants and facilities, equipment, materials, hygiene, verification, documentation, production management, quality management, product sales and recovery, complaints and adverse reaction reports, self-inspection.

 

PHARMA CLEAN supply clean room as per the target elements:

Keep human error to a minimum;

Prevent contamination and quality degradation of medicines;

A quality management system that guarantees high-quality products.

 

The quality of medicines is formed during the production process, not by inspection.

Therefore, we must emphasize prevention first, establish a quality assurance system in the production process, implement comprehensive quality assurance, and ensure the quality of drugs.

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Suzhou Pharma Machinery Co.,Ltd.

2022/06/23

Spencer


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