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[求助]
原料药申报问题 已有8人参与
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原工艺有四步反应，现在想以第二步产品为起始原料申报，前两步体现公司自制原料，这样可以吗， 可以额话，前两步的原料需要做什么研究呢？谢谢。 |
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【答案】应助回帖
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感谢参与，应助指数 +1
ypzc0818(News代发): 金币+2, 感谢回帖交流 2014-05-26 10:12:38
感谢参与，应助指数 +1
ypzc0818(News代发): 金币+2, 感谢回帖交流 2014-05-26 10:12:38
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TOP 2 (3.2.S.2.2) / (3.2.S.2.3): Proposed starting material not accepted: More and more frequently, applicants propose short synthesis, with complex products proposed as starting materials in the application. This is generally not acceptable and the complex material is considered by the assessors as an intermediate in the synthesis. Applicants are reminded that the approved starting material is the starting point for GMP and variations, and must be representative of the overall synthetic process and not just a late intermediate resulting in a shortened synthesis. The proposed starting material should be justified. Proposing a complex molecule as starting material may lead to a request for redefinition of the starting material further back in the synthesis. The policy for definition of Starting Materials for APIs applied at EDQM is the following: — The proposed starting materials should generally not have a structure that is very close to that of the final substance in relative size and complexity (but will depend on the number of steps to the final active substance). — Multiple synthesis steps should separate the starting material(s) and the active substance. A synthesis step is a step in the synthesis where covalent bonds are formed or broken. A process consisting of only 1-2 steps is generally not sufficient to ensure full control of the quality of the final substance. Fewer steps may be acceptable in some cases, for example for simple molecules, or when the proposed starting material is the subject of a CEP. — The full description of the process should cover all the synthetic steps critical for safety (impurities) and/or efficacy; such as steps in which a genotoxic substance is used or formed, step contributing to the overall stereochemistry of the active substance or steps such as biocatalytic transformations. — Commercial availability is an insufficient justification to accept a starting material. Starting materials produced by custom synthesis and those available commercially are not accepted unless supported by additional criteria as described above. — It is the combination of the number of chemical synthetic transformation steps carried out under GMP and the control strategy applied to these steps, which provides assurance of quality of the active substance. — The name and address of manufacturers of starting materials should be stated in the dossier. — In order to justify the specifications of the starting material information on the manufacture of the starting material should be provided. This should include a flow diagram outlining enough steps of the synthesis and information on the solvents, reagents and catalysts used during its synthesis. — Any declaration on GMP and/or on willingness to be inspected presented by starting material manufacturers will in effect have no influence on which substance will be accepted as an appropriate starting point for the part of the synthesis since GMP cannot be imposed for the manufacture of a starting material. — An appropriate control strategy should be proposed to ensure the robustness and consistency of the manufacturing process. When the assessors do not accept the proposed Starting Material(s) and a redefinition is asked for, suppliers of the proposed materials will thus become suppliers of intermediates and consequently the relevant declarations (compliance with GMP and willingness to be inspected) from these suppliers must be provided. This implies also that related updated CTD sections are provided to reflect the finally approved route of synthesis (from the redefined starting material to the final substance). |
10楼2014-05-23 09:26:36
