What is a GMP facility?

In the biopharmaceutical industry, GMP equipment has strict requirements.

First, the design of GMP equipment should be reasonable and scientific, and its structure should be easy to clean, disinfect and maintain to prevent the drug from being contaminated during the production process. For example, the surface of the equipment should be smooth and without dead corners to avoid the breeding of microorganisms by material residues.

In terms of material selection, non-toxic, corrosion-resistant materials that do not chemically react with drugs must be used. For example, in equipment for producing injections, parts that come into contact with the drug solution are usually made of materials such as stainless steel that meet pharmaceutical standards.

In terms of installation, GMP equipment should be installed in a suitable location to ensure sufficient spacing between equipment, equipment and walls and ceilings, etc., to facilitate operation, cleaning and maintenance. At the same time, it is necessary to ensure that the air circulation and temperature and humidity control of the production environment meet the requirements.

During operation, the equipment should be stable and reliable, and be able to accurately control various parameters such as temperature, pressure, speed, etc. to ensure the consistency and repeatability of the drug production process.

 Validation is an important part of GMP equipment, including installation qualification (IQ), operation qualification (OQ) and performance qualification (PQ).

 Only equipment that meets GMP standards can be used in drug research and development, production, and quality control, which plays a key role in ensuring the safety, effectiveness, and quality stability of drugs.