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生物制品生产过程中的合规痛点和难点：
Pain points and difficulties of compliance in the production process of biological products:
1.生物制品起始材料为生物活性物质（包括菌、毒种、细胞等），生物制品生产全过程是生物学过程，对生产工艺要求严格，质量控制实行生产全过程监控；
1. The starting materials of biological products are bioactive substances (including bacteria, virus seeds, cells, etc.). The whole production process of biological products is a biological process. The production process is strictly required, and the quality control is monitored throughout the production process;
2.生物制品多为蛋白质或多肽类物质，分子量较大，并具有复杂的分子结构，较不稳定，易失活，易被微生物污染，易被酶解破坏，无法全部按照简单的加热灭活等方式进行处理；
2. Biological products are mostly protein or polypeptide substances with large molecular weight and complex molecular structure, which are unstable, easy to inactivate, easy to be contaminated by microorganisms, easy to be destroyed by enzymatic hydrolysis, and can not be all treated by simple heating inactivation;
3. 生物制品产品的质控、质检等采用生物学分析方法，需时较长，过程复杂，其效价或生物活性检定有其变异性；
3. Biological analysis method is adopted for quality control and quality inspection of biological products, which takes a long time and involves complex process, and its potency or biological activity verification has its variability;
4.生物制品原材料、中间品、成品、运输、贮存、甚至使用保持在“冷链”系统中，对于“稳定性”要求高，需要严谨完善的质量监管体系；
4. Raw materials, intermediates, finished products, transportation, storage, and even use of biological products are kept in the "cold chain" system, and strict and perfect quality supervision system is required for high requirements on "stability";
5. 生物制品上市后变更对于产品质量的潜在影响更为复杂（生产场地变更、工艺变更、质控标准变更、原辅料变更等）；
5. The potential impact of changes in biological products after marketing on product quality is more complex (changes in production site, process, quality control standards, raw and auxiliary materials, etc.);
6.预防用生物制品区别于其他药品，使用对象是健康人群，对于安全性、有效性等方面有其特殊考虑；血液制品来源特殊，需要对血浆等采取特别监管。
6. The biological products for prevention are different from other drugs, and the objects of use are healthy people, with special consideration on safety, effectiveness and other aspects; The source of blood products is special, which requires special supervision on plasma, etc.