directiva de manufactura

03:53 Aug 1, 2016 

'Manufacturing guide' seems to fit the context. Best practices are almost always formulated by technical bodies as recommendations for manufacturers. In other words, they are not initiated by manufacturers.

02:12 Aug 1, 2016 

I'm thinking of just translating it as "manufacturing guide," as that would seem to suggest a single, possibly internal document with such instructions that could also have its own code. What do you think?

00:25 Jul 29, 2016 

some pause is the first page of the same document (linked below). If three batches are being validated, why is there only space for a single "directiva de manufactura" code? Granted, I've read that "lote" can either be "batch" or "lot" (which I understand to be a part of a batch, particularly one that has been completed and packaged). Any comments on this?

https://s32.postimg.org/bp126kfqt/directiva_de_manufactura_2...

So basically, I'm looking for some kind of document with internal guidelines and records that refers to a master formula (AKA master manufacturing record) but is distinct from it, and that has its own code. Does BPR fit these criteria?

19:17 Jul 28, 2016 

I think you're on the right track. It seems very similar.

19:16 Jul 28, 2016 

While I felt it was necessary to redact at least the internal procedure number of the first screen capture I posted, I can tell you that the title relates to preparing master documents.

19:14 Jul 28, 2016 

I also wonder if the information on p. 12 of the WHO Guide to Master Formulae linked below is relevant (which is about the relationship between master formulae [which I assume corresponds to "fórmula maestra de producción" in my document] and BPRs):

http://www.who.int/immunization_standards/vaccine_quality/gu...

19:13 Jul 28, 2016 

I don't know the answer, but the snapshots appear to refer to internal standards of the manufacturer, especially since they also refer to good manufacturing practices - in other words, a directive established *by* the manufacturer rather than recommended *to* the manufacturer. Still, it is much more extensive than the instructions for use that one sees in the package insert, as in the following example:

Goldman-Cecil Medicine - Page 588 - Google Books Result
https://books.google.com/books?isbn=0323322859
Lee Goldman, ‎Andrew I. Schafer - 2015 - ‎Medical
... of one combination oral contraceptive pill every 6 hours for 5 to 7 days, although this use is not listed in the **manufacturer's directive** or approved by the FDA.

18:34 Jul 28, 2016 

Taking this section into consideration it may refer to directives or practices. In either case you could use directive or practices. I would be inclined to refer to GMP in the title and directives in the table. The same word can have various meanings and the context is what should prevail. You could also use guidelines. The table refers to a specific text or document that is the sets the standard to be complied with. Good luck.

18:27 Jul 28, 2016 

18:18 Jul 28, 2016 

examples. Thanks again!