founded. Р 1.7此外QP有责任保证1.7.1到1.7.21的条款。可委托给适当培训人员或第三方。QP须信赖药品质量体系且QP应持续确保这些信赖是有据可循的。Р1.7.1 All activities associated with manufacture and testing of the medicinal product have been conducted in accordance with the principles and guidelines of GMP. Р 1.7.1涉及医疗产品制造及检测的所有活动都要符合GMP指南规定。Р1.7.2 The entire supply chain of the active substance and medicinal product up to the stage of certification is documented and available for the QP. This should include the manufacturing sites of the starting materials and packaging materials for the medicinal product and any other materials deemed critical through a risk assessment of the manufacturing process. The document should preferably be in the format of prehensive diagram, where each party, including subcontractors of critical steps such as the sterili
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