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Our strength as herbalists is that we come together. We share processing tips and secret harvest spots (sometimes - depending on who's asking), discuss difficult cases, and generally help each other learn. This has been evident to me all the way from herbalist pot-lucks to the biggest herb conferences. Now I believe it is time for us to come together on another critical issue: the modern regulatory environment, enforced by the FDA, in which we find ourselves.


**NOTE: all the information presented under the "FDA cGMP compliance open source project" is not intended to be legal advice, nor is it in any way guaranteed that our interpretation of the statute and system for compliance is going to satisfy any individual FDA inspector or compliance officer. These pages are a synthesis of our own understanding of the regulations and how to achieve compliance.


DescriptionComplete
How do we address the cost of contaminant testing (microbiological/heavy metal/pesticide)?  
Agenda for online live forum discussion  
Multi-botanical product ID and strength testing compliance  
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Messages

  • Vendor Qualification One important piece of an overall program for cGMP compliance is to make sure that what you're starting with - your raw materials - meet all the quality standards and specifications ...
    Posted Feb 3, 2016, 6:23 PM by Guido Masé
  • Warehouse controls While this topic refers to a warehouse, its basic principles apply in any manufacturing or storage setting when dealing with dietary supplements: regardless of whether it's 400 or 4 ...
    Posted Jan 27, 2016, 7:28 PM by Guido Masé
  • Manufacturing - the MMR for bottling To bottle, label and seal a final product (in this case a tincture), you follow essentially the same setup as you do with the manufacture of the liquid extract itself ...
    Posted Jan 20, 2016, 8:18 PM by Guido Masé
  • Manufacturing - the MMR for tincturing "MMR" stands for "master manufacturing record". This is a blueprint or template for creating a dietary supplement; in this case, it is a blueprint for creating an herbal tincture. This ...
    Posted Jan 13, 2016, 6:27 PM by Guido Masé
  • Raw Material specifications - document upload Under the "Files" tab, find uploaded specification sheets for raw cut-and-sifted (and occasionally powdered) herbs. These represent over 50 botanicals, and include a specification for ethanol (alcohol) as ...
    Posted Jan 6, 2016, 6:41 PM by Guido Masé
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