关于不同批量的批记录设计

beiwei5du

The following are the extracted definitions from several guidelines: • WHO GMP Guidelines: A formally authorized master formula should exist foreach product and batch size to be manufactured.
• EU and PIC GMP guidelines: “Formally authorised Manufacturing Formulaand Processing Instructions should exist for each product and batch size to bemanufactured. They are often combined in one document.”
• Health Canada GMP guidelines. MASTER FORMULA (formule-type) - Adocument or set of documents specifying the raw materials with their quantitiesand the packaging materials, together with a detailed description of the proceduresand precautions required to produce a specified quantity of a finished product aswell as the processing instructions, including the in-process controls.
• US CFR. To assure uniformity from batch to batch, master production andcontrol records for each drug product, including each batch size thereof, shall beprepared, dated, and signed (full signature, handwritten) by one person andindependently checked, dated, and signed by a second person. The preparation of Guide to master production and control records shall be described in a written procedureand such written procedure shall be followed.  


1、在现实中有看到部分企业针对于不同batch size设计一个批记录（在批记录中使用系数进行相应的换算），在某种程度上按照合理性来说应该是可以的，但是按照合规性来说则是和上面提到的一些guideline有冲突，请问大家是怎么做的呢？？？
2、按照美国联邦法规CFR21的要求，应该制定相应的master production and control records编制规程，大家有制定吗？？？

药半仙

我们现在就是按照这个规定执行的。