澳大利亚农药制剂登记化学资料要求和审查要点

Data requirements on chemistry and manufacture and critical points of assessment for registration of agricultural chemical products in Australia

对化学和生产数据进行评估,以确认配方产品中所含化合物的身份,并确认配方产品的规格,包括产品中可能存在的任何重要和/或相关杂质的规格。评估还应确认制备过程处于控制之中,并将按照描述和规范生产产品配方。对于配方产品,还对产品的稳定性进行了评估。需要对测量技术进行验证,以确保它们适合于特定的目的,以确认它们准确地代表了所存在的化合物,并且用于解释数据的任何统计分析都是适当的。化学数据还提供了对人类健康、残留物、饮食风险和产品环境风险评估有用的理化参数。

Chemistry and manufacture data is evaluated to confirm the identity of the compounds contained in formulated products and to confirm the specifications for formulated products including specifications for any significant and/or relevant impurities likely to be present in the products.The assessment should also confirm that the manufacturing processes are under control and the formulated products will be produced with the processes as described and within specifications.For formulated products,an assessment of the stability of the product is also conducted.The measurement techniques need to be validated to ensure they are fit for purpose to confirm that they accurately represent the compounds present and that any statistical analysis used to interpret that data is also appropriate.The chemistry data also provides physicochemical parameters useful to the human health,residues and dietary risk and environmental risk assessments of a product.