题主您好，首先需要纠正一点，对于欧美法规，并不是完全不允许共线的。欧洲GMP中是这样规定的：
EudraLex The Rules Governing Medicinal Products in the European Union
Volume 4 EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use
Part 1 - Chapter 3: Premises and Equipment
3.6 Cross-contamination should be prevented for all products by appropriate design and operation of manufacturing facilities. The measures to prevent cross-contamination should be commensurate with the risks. Quality Risk Management principles should be used to assess and control the risks.
Depending of the level of risk, it may be necessary to dedicate premises and equipment for manufacturing and/or packaging operations to control the risk presented by some medicinal products.
Dedicated facilities are required for manufacturing when a medicinal product presents a risk because:
i. the risk cannot be adequately controlled by operational and/ or technical measures,
ii. scientific data from the toxicological evaluation does not support a controllable risk (e.g. allergenic potential from highly sensitising materials such as beta
lactams) or
iii. relevant residue limits, derived from the toxicological evaluation, cannot be satisfactorily determined by a validated analytical method.
Further guidance can be found in Chapter 5 and in Annexes 2, 3, 4, 5 & 6.
此外，关于题主所说的CFDI指南要求考虑上个产品基因毒性杂质残留，不清楚是出自哪里？如果是国家药品监督管理局食品药品审核查验中心在2024年7月发布的清洁验证技术指南 (征求意见稿)，通篇只提到毒理学评估，并没有提及基因毒性杂质评估。毒理学评估并不等同于基因毒性杂质评估。
就现有法规来看，清洁限度计算无需特别考虑上个产品的基因毒性杂质残留。如下欧洲法规，也只是提到了需要进行毒理学的评估：
EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use - Annex 15: Qualification and Validation
10.6. Limits for the carryover of product residues should be based on a toxicological evaluation. The justification for the selected limits should be documented in a risk assessment which includes all the supporting references. Limits should be established for the removal of any cleaning agents used. Acceptance criteria should consider the potential cumulative effect of multiple items of equipment in the process equipment train.
10.6.1. Therapeutic macromolecules and peptides are known to degrade and denature when exposed to pH extremes and/or heat, and may become pharmacologically inactive. A toxicological evaluation may therefore not be applicable in these circumstances.
10.6.2. If it is not feasible to test for specific product residues, other representative parameters may be selected, e.g. total organic carbon (TOC) and conductivity.
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不需要考虑，基因毒性杂质本身就是微量杂质在上批主成分中已经控到了相当低的水平，在下批产品清洁过程中，已经考虑了该基因毒性杂质相关的主成分API的限度在较低水平，更不用说基因毒性杂质会远低于限度值。