What is the difference between a GMP standard factory building and a standard factory building? Can an already built standard factory building be transformed into a GMP factory building?

The concept of standard factory building should be included in GMP standard factory building.

1. Standard factory buildings include: The installation of equipment should meet the requirements, including equipment spacing, rationality of process flow, etc. The fire protection design must be reasonable and ensure compliance with fire safety requirements. The workshop must be divided into areas, including processing areas, product storage areas, raw material storage areas, rest areas, etc. Power cabinets such as power distribution and lighting must meet safety requirements. Slogans, logos, operating procedures, and layout plans should be eye-catching, and there should be publicity boards. Setting management. The width of the entire passage should be greater than 1.4 meters, the width of the main passage should be greater than 3 meters, the width of the pedestrian passage should be greater than 0.8 meters, etc.

2. GMP standard factory buildings refer to workshops that meet the requirements of pharmaceutical or food quality and safety management systems. Pay more attention to the implementation of independent management systems for product quality and health safety during the production process. It requires enterprises to meet sanitary quality requirements in accordance with relevant national regulations in terms of raw materials, personnel, facilities and equipment, production processes, packaging and transportation, quality control, etc., and form a set of operable operating specifications to help enterprises improve the sanitary environment of enterprises and timely detect errors in the production process. existing problems and improve them.

For this kind of specific major modification, it is better to consult the Safety Supervision Division or relevant departments of the local Food and Drug Administration, because even if you complete the modification, you still need to get their approval.