3.2. Warehouse, the area where you store raw materials, materials, intermediates and drugs under controlled conditions of order and cleanliness. 仓库,在受指令和清洁程度控制的用于储存原料,物料,中间体和成品的地方 3.3. Good Manufacturing Practice, the set of guidelines and monitoring activities related ...
and seeks to transform the experience-oriented enterprise management model of pharmaceutical companies into a scientific enterprise management model.To implement the control mode of comprehensive informationization of pharmaceutical enterprises from raw material procurement, production control, warehouse management ...
药品生产企业GMP认证申报资料技术要求(Technicalrequirements forGMPcertificationapplicationmaterialsofpharmaceutical manufacturingenterprises) TechnicalrequirementsforGMPcertificationapplication materialsofpharmaceuticalmanufacturingenterprises I.applicationforcertification Thenameofthebusinessshouldbeconsistentwiththenameof theenterprise...
A drug distributor to be established shall meet the following requirements1) staffed with legally qualified pharmaceutical professionals;(2) provided with the business operation premises, equipment, warehouses, and clear environment required for drug distribution;(3) having the quality control units or ...
written procedures and records for control of unqualified materials and products, return of goods to the warehouse, disposal reports, and handling of emergencies, etc. 3、不合格品管理、物料退库和报废、紧急情况处理等制度和记录;4. written procedures and records for hygiene and sanitation of the ...
or the existence of calibration labels. Moreover, new Chinese GMPs includes requirements on the ...
1.1. Apart from the building requirements contained Part-I, General note, the active pharmaceutical ingredients facilities for manufacture of hazardous reactions, Beta-Lactum antibiotics. Steroids and Steroidal Hormones / Cytotoxic substances shall be provided in confined areas to prevent contamination of ...
1.1. The system of quality assurance appropriate to the manufacture of pharmaceutical products should ensure that: 适合于医药产品生产的质量保证系统,应确保: a) Pharmaceutical products are designed and developed in a way that takes account of the requirements of GMP and other associated codes such as...
GMP audit requirements vary for pharmaceutical, medical, dietary supplements and cosmetics markets. Nevertheless, all of them have a common structure, tailorized more specifically depending on the criticality and market of destination. Depending on the scope of the audit, our GMP Audit repor...
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