上海朗圣医药科技有限公司位于漕河泾开发区聚科生物园区内,主要专业从事GMP咨询和GMP验证服务。GMP咨询包括原料药、医疗器械、制剂工厂的CFDA、FDA、EU、TGA、WHO等国内外GMP认证咨询。GMP验证服务包括DQ/IQ/OQ/PQ的GMP验证服务,涉及厂房、公用系统、设备、仪器等硬件设施的确认,以及方法验证、工艺验证、计算机系统验证等。公司具有CMA资质,可开展净化系统、恒温恒湿系统、气体系统、灭菌系统、蒸汽系统的有关验证测试。
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