Particles Filtration Not Acceptable

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Particles Filtration Not Acceptable
欧洲药品管理局（EMA）最近增加了一个有趣的问题，以它的问答部分。如何接受之前的医药产品用于非肠道使用的管理。颗粒过滤？这个问题解决了颗粒例如的问题，是由于以下的橡胶塞的穿刺玻璃或橡胶粒子的脱层。现在的问题是问这是否可能是由用户指令使用之前申请一个特定的过滤器进行补偿。
正如预期的那样，均线的答案是明确的“不”。对高品质产品的责任不能转移的病人。在某些情况下，人们宁可说原制剂的变形例的，以避免 - 例如 - 玻璃的脱层。
更详细的信息，请在Q＆在EMA网站的一段原文。

The European Medicines Agency (EMA) has recently added an interesting question to its Questions & Answers section. How acceptable is filtration of particles prior to the administration of a medicinal product for parenteral use? This question addresses the problem of particles for example due to delamination of glass or rubber particles following puncture of the rubber stopper. The question is asked whether this might be compensated by a user instruction to apply a specific filter before use.
As might be expected, the answer of the EMA is an unequivocal "no". The responsibility for high-quality products can't be transferred to the patient. In certain cases, one would rather speak of a modification of the original formulation to avoid - for example - delamination of glass.
More detailed information is available in the original text of the Q&A section on the EMA website.

lumang

1. If particles which originate from the container-closure system develop during the production, storage or handling of a liquid solution, is the inclusion of a mandatory filtration step in the SmPC or package leaflet acceptable to compensate for this? Examples include the introduction of glass particles due to delamination of glass walls and the introduction of rubber particles following puncture of the rubber stopper? (H+V) April 2014

No, in principle it is not acceptable to compensate for insufficient quality of raw materials (glass containers, rubber stoppers) or insufficient product development (which results in, for example, the formation of glass particles or the introduction of rubber in the finished product) by a user instruction to apply a specific filter prior to administering the product to a patient (or animal).

It is the responsibility of the applicant to develop a product of adequate quality and this includes the container-closure system. In certain cases a modification of the original formulation might be required to assure optimal compatibility with the primary packaging material. This responsibility cannot be partially transferred to the user/patient by an avoidable instruction. The use of a specific filtration step for this purpose may only be considered acceptable by the competent authorities in specific circumstances, for example, temporarily during redevelopment of a product with a high medical need.

The use of a specific filtration step for other purposes is not within the scope of this Q&A.

Where relevant, the issue of glass delamination should be addressed in sections 3.2.P.2 and 3.2.P.7 (or veterinary equivalent) of the Marketing Authorisation dossier. It is noted that available scientific data indicate that glass delamination is commonly related to insufficient quality and consistency of glass vial manufacturing, and that data suggest that intra-batch consistency of a batch of vials may not always be guaranteed.In addition, certain formulations (especially those containing citrate, phosphate, or acetate or having a high ionic strength) seem to introduce an inherent risk.

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lumang 发表于 2014-6-30 09:39
1. If particles which originate from the container-closure system develop during the production, sto ...

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