咨询CFR211.186条款的理解

零下

近期学习CFR211条款，211.186 Master production and control records.生产和控制主记录，其中有一条“应制订并遵循关于生产与控制主记录的准备操作的书面规程。”
这句话如何理解，或者需要做什么文件么？
有大神指导下，或者拉进FDA的交流群么

大小王是王炸

我理解就是批生产包装检验记录 。批记录全生命周期的的管理规定。各公司应该都有批记录管理的文件吧

木叶忍者

我的理解是，制定空白批记录的修订、发放、领用、传递的相关流程，确保批记录的流转受控。

chinsss

下次记得带英文一起发
§ 211.186 Master production and control records.

(a) To assure uniformity from batch to batch, master production and control records for each drug product, including each batch size thereof, shall be prepared, dated, and signed (full signature, handwritten) by one person and independently checked, dated, and signed by a second person. The preparation of master production and control records shall be described in a written procedure and such written procedure shall be followed.

(b) Master production and control records shall include:

(1) The name and strength of the product and a description of the dosage form;

(2) The name and weight or measure of each active ingredient per dosage unit or per unit of weight or measure of the drug product, and a statement of the total weight or measure of any dosage unit;

(3) A complete list of components designated by names or codes sufficiently specific to indicate any special quality characteristic;

(4) An accurate statement of the weight or measure of each component, using the same weight system (metric, avoirdupois, or apothecary) for each component. Reasonable variations may be permitted, however, in the amount of components necessary for the preparation in the dosage form, provided they are justified in the master production and control records;

(5) A statement concerning any calculated excess of component;

(6) A statement of theoretical weight or measure at appropriate phases of processing;

(7) A statement of theoretical yield, including the maximum and minimum percentages of theoretical yield beyond which investigation according to § 211.192 is required;

(8) A description of the drug product containers, closures, and packaging materials, including a specimen or copy of each label and all other labeling signed and dated by the person or persons responsible for approval of such labeling;

(9) Complete manufacturing and control instructions, sampling and testing procedures, specifications, special notations, and precautions to be followed.

零下

chinsss 发表于 2024-7-12 09:52
下次记得带英文一起发
§ 211.186 Master production and control records.

中英文的标准都有，就是如何理解和具体操作这些要求。