正如2022年联合反思文件（JRP）所指出的，有效管理药品生产工艺变更颇具挑战性，尤其是对向多个地区提交相同申报资料的上市许可持有人（MAH）而言。由于各国/地区特有的惯例和法律/监管要求，申报资料在格式和内容上存在差异也在意料之中。这种不一致还会降低监管机构的效率，并阻碍监管机构与生产设施之间共享知识、使监管决策更加灵活敏捷的互认依赖工作。设想中的PQKM系统旨在加强国际合作，支持药品及生物制品/生物技术产品的全球研发、生产与供应。
As pointed out in the 2022 Joint Reflection Paper (JRP), effectively managing changes to pharmaceutical manufacturing processes is challenging, especially to marketing authorization holders (MAH) submitting the same dossier to multiple regions. Different formats and contents in the dossier are expected due to country/region specific conventions and legal/regulatory expectations. Such inconsistencies also cause inefficiency amongst regulators and hamper mutual reliance efforts to share knowledge amongst regulators and facilities to be more nimble, agile in regulatory decision making. The envisioned PQ KM system aims at strengthening international collaboration to support global development, manufacture, and supply of pharmaceutical and biological/biotechnological products.