在欧美系的外资药厂里工艺规程叫什么？

被吹散的婆婆丁

如题，工艺规程在大陆企业里面的叫法，那么在一些外资企业里面，这个性质的文件的名称是什么？
请有经验的同僚给讲讲

董光宇1

就是批生产记录

JimmyHE8888

SOP（标准操作规程） 或者BMR（批生产记录）吧，看具体用途

dengjianyyy

美国叫“written procedures for production and process control"
21 CFR Part211.100 Written procedures; deviations
There shall be written procedures for production and process control designed to assure that the drug
products have the identity, strength, quality, and purity they purport or are represented to possess. Such
procedures shall include all requirements in this Subpart. These written procedures, including any changes,
shall be drafted, reviewed, and approved by the appropriate organizational units and reviewed and approved
by the quality control unit.

VS____L

XXX process procedure或者XXX process description.用前者的居多。

被吹散的婆婆丁

dengjianyyy 发表于 2022-10-13 16:39
美国叫“written procedures for production and process control"
21 CFR Part211.100 Written procedure ...

这些国内要求翻译过来就是工艺规程吧？文件名称

dengjianyyy

nikonpro 发表于 2022-10-14 09:35
这些国内要求翻译过来就是工艺规程吧？文件名称

天下文章一大抄，创新是不存在的，我们对工艺规程的要求也是照洋鬼子的要求来，这实际就是我们说的工艺规程。
但是高大上的话就要看怎么翻译了，翻译成“书面的生产和中间过程控制程序”，明显比工艺规程洋气，字数也多一些。

被吹散的婆婆丁

dengjianyyy 发表于 2022-10-14 09:59
天下文章一大抄，创新是不存在的，我们对工艺规程的要求也是照洋鬼子的要求来，这实际就是我们说的工艺规 ...

这个比较有TVB腔的感觉了

猫咪特工

其实也叫工艺规程

来自安卓APP客户端

左心室

MPI-Master Production Instructions(ICH Q7 6.4)

liuaosun

国外等同于工艺规程的文件名称和出处
1、 ICH Q7A  6.4   Master production instruction (Master production and control records)
To ensure uniformity from batch to batch, master production instructions for each intermediate and API should be prepared, dated, and signed by one person and independently checked, dated, and signed by a person in the quality unit(s) 含指导生产过程的文件，通常包含生产处方，操作要求，包装说明
Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients Guidance for Industry
2、 EU GMP  chapter IV  Manufacturing formula + Processing instructions
Approved, written Manufacturing Formula and Processing Instructions should exist for each product and batch size to be manufactured.生产过程的详细指令和操作方法和处方
Chapter 4 Final 0910
3、 FDA 21 CFR part 211. 186  Master production and control records
master production and control records for each drug product, including each batch size thereof, shall be prepared, dated, and signed
eCFR :: 21 CFR 211.186 -- Master production and control records.
4、 Health Canada GMP 26  Manufacturing formula packaging + Packaging master formula
Ensure processing operations are covered by a master formula. The master formula should be in accordance with the marketing authorization. The master formula must be prepared by—and subject to independent checks by—production and quality control personnel who have the qualifications described under section C.02.006
Good manufacturing practices guide for drug products (GUI-0001) - Canada.ca
5、 WHO GMP 15.22 Master formula and master batch record
A formally authorized master formula should exist for each product and batch size to be manufactured.生产阶段详细的指导文件
trs986annex2.pdf
6、 FDA CFR 211 sec.211.100 written procedures（written production and process control procedure）
   There shall be written procedures for production and process control designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess. Such procedures shall include all requirements in this subpart. These written procedures, including any changes, shall be drafted, reviewed, and approved by the appropriate organizational units and reviewed and approved by the quality control unit.
eCFR :: 21 CFR 211.100 -- Written procedures; deviations.