What is GMP

What’s GMP?

GMP is the abbreviation of Good Manufacturing Practice. It is a management system that pays special attention to the implementation of product safety and hygiene in the whole process of product production and processing. It is also a set of measures, methods and technical requirements throughout the production process.

What is GMP certification

GMP is a set of mandatory standards applicable to the pharmaceutical, food and other industries. It requires enterprises to meet hygienic quality requirements in accordance with relevant national regulations in terms of raw materials, personnel, facilities and equipment, production process, packaging and transportation, quality control, etc., and form a set of operable The operating specifications help enterprises to improve the sanitary environment of the enterprise, find out the problems existing in the production process in time, and make improvements.

In short, GMP requires pharmaceutical, food and other production enterprises to have good production equipment, reasonable production process, perfect quality management and strict inspection system to ensure that the quality of final products (including food safety and hygiene) meets regulatory requirements.

What is a GMP workshop?

GMP workshop is a type of dust-proof workshop. The walls and roof of the purification workshop are generally made of 50mm-thick sandwich color steel panel, which are characterized by beautiful appearance and strong rigidity. The arc corners, doors and window frames are generally made of special oxidation manufacturing of aluminum profiles.

What are the structural materials of GMP workshop?

1. The floor can be epoxy self-leveling floor or high-grade wear-resistant plastic floor. If there are anti-static requirements, anti-static type can be selected.

2. The supply and return air ducts are made of hot-dip zinc plates, and are pasted with flame-retardant PF foamed plastic plates with good purification and thermal insulation effects.

3. The stainless steel frame is used for the high-efficiency air outlet, which is beautiful and clean. The perforated mesh plate is made of painted aluminum plate, which does not rust and does not stick to dust, so it should be cleaned.

GMP clean workshop purification parameters:

Number of air changes:

100000 level ≥15 times;

10000 level ≥ 20 times;

1000≥30 times.

Pressure difference: the main workshop to the adjacent room ≥ 5Pa

Average wind speed: 10, 100 0.3-0.5m/s;

Temperature winter>16℃;

Summer <26°C; fluctuation ±2°C.

Humidity 45-65%;

The humidity of the GMP powder workshop should be about 50%; the humidity of the electronic workshop is slightly higher to avoid static electricity. Noise≤65dB(A); Fresh air supplementary volume is 10%-30% of total air supply volume; Illumination 300LX

Suzhou Pharma Machinery Co.,Ltd.

2022/06/09

Spencer