File Size: 456 kb
Description
In pharmaceutical manufacturing, how space conditions impact the product being made is of primary importance. The pharmaceutical facilities are closely supervised by the U.S. food and drug administration (FDA), which requires manufacturing companies to conform to cGMP (current Good Manufacturing Practices). These regulations, which have the force of law, require that manufacturers, processors, and packagers of drugs to take proactive steps to ensure that their products are safe, pure, and effective. GMP regulations require a quality approach to manufacturing, enabling companies to minimize or eliminate instances of contamination, mix ups, and errors.
The GMP for HVAC services embraces number of issues starting with the selection of building materials and finishes, the flow of equipment, personnel and products, determination of key parameters like temperature, humidity, pressures, filtration, airflow parameters and classification of cleanrooms. It also governs the level of control of various parameters for quality assurance, regulating the acceptance criteria, validation of the facility, and documentation for operation and maintenance.
The GMP for HVAC services embraces number of issues starting with the selection of building materials and finishes, the flow of equipment, personnel and products, determination of key parameters like temperature, humidity, pressures, filtration, airflow parameters and classification of cleanrooms. It also governs the level of control of various parameters for quality assurance, regulating the acceptance criteria, validation of the facility, and documentation for operation and maintenance.
Author Details
"A. Bhatia"
You May Also Like:-
No comments:
Post a Comment