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Author: Subject: Production of pharmaceutical grade (USP, EP, BP, JP) compounds
macckone
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[*] posted on 23-10-2018 at 19:28


The methods for manufacture. Not the test methods.

These are tests not manufacturing instructions.
You are free to use any manufacturing methods provided they meet the specs and don't introduce dangerous impurities.

The beginning section says that
"Official substances are to be prepared according to recognized principles of good manufacturing and from ingredients complying with the specifications designed to ensure that the resultant substances meet the requirements of the compendial monographs (see also Foreign Substances and Impurities under Tests and Assays)."

It also says "There may be deviation from the specified processes or methods of compounding though not from the ingredients or proportions thereof, provided the finished preparation conforms to the relevant standards laid down herein and to preparations produce by following the specified process"

It is literally saying you don't have to follow a specific process to manufacture it. But the process does have to be sound and the product has to meet the specifications including no foreign substances can be present.
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[*] posted on 24-10-2018 at 13:02


Fair point; they don't care where you get the material from, as long as it passes the tests.

Things like GMP and GLP do that.

[Edited on 24-10-18 by unionised]
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[*] posted on 25-10-2018 at 00:29


Industrial standards only watch on quality through many standardized measurement methods.

Process of production can then evolve in many way to improve sustainability, cost or safety, without rewriting all standards with new innovation (and there are plenty of innovation all time). Innovation has a cost and need invest, by this way this cost is only supported by the industrial who claim to "change the world" and standard revision occurs by other actors (politics or else) with theoretical no conflict of interest.
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