gmp（GMP）.docVIP

gmp（GMP） Quality requirements: powder without foreign body, after the preparation of clarity, qualified powder fineness or crystallinity appropriate, easy to separate, aseptic and pyrogen free. The drug powder which meets the requirements of the injection is directly packed into sterilized vials or ampoules under aseptic conditions. Determination of physical and chemical properties of materials: 1. thermal stability: the purpose is to determine whether the product can be sterilized at last. 2. critical relative humidity: the relative humidity of the packing room must be controlled below the critical relative humidity of the packed product so as not to absorb moisture. The crystal type 3. powder: powder crystal and preparation process are closely related, such as spray drying method for the spherical packing machinery, easy to control, and a solvent crystallization needle and flake or various characters of polyhedron, needle powder packing is the most difficult to master. 4. the bulk density of the powder: measure the weight of the drug in the unit volume, easy to separate. Sterilization and foreign body examination For heat-resistant varieties, such as penicillin, they can be supplemented and sterilized according to the above conditions, so as to ensure safety. For non heat resistant varieties, aseptic processing must be strictly carried out and products are not sterilized. Inspection of foreign objects is usually carried on the conveyor belt and examined by eye. In brief, the GMP requirements of food production enterprises should have a good production equipment, a reasonable production process, improve the quality of management and strict inspection system, to ensure the quality of the final product (including food safety and health) to comply with regulatory requirements. Drug production quality management standards (Good Manufacture, Practice, GMP) is the basic criteria of pharmaceutical production and quality management, key processes that influence the product