GMP Resources

With GMP encroaching into all aspects of cannabis production above and beyond medical a data dump on all things GMP might be useful. Please join the data dump for those interested in this space.

Medicinal cannabis manufacture
Technical guidance on the interpretation of the PIC/S Guide to GMP

medicinal-cannabis-manufacture.pdf (535.6 KB)

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If you want paperwork to go with your research, this course was $25 and i found it very informative: https://foodsafety.ncsu.edu/good-manufacturing-practices/

Edit: Strap in, it took quite a few hours to complete.

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More GMP Data Dump:

GXP
Application of GMP in the Cannabis Industry

http://www.ivtnetwork.com/article/application-gmp-cannabis-industry

Medicinal cannabis: What it takes to be GMP-ready

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A Basic FAQ on GMP

Along with detailed intro video on Cannabis GMP

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All you need here:

Electronic code of federal regulations
Title 21 CFR “Good Manufacturing Practices”
Food and Drugs

https://www.ecfr.gov/cgi-bin/text-idx?SID=3ee286332416f26a91d9e6d786a604ab&mc=true&tpl=/ecfrbrowse/Title21/21tab_02.tpl

These are the standards US states will point to when drafting their state regulations and policies for medical or rec. cannabis

PS - Dm me if you wanna learn more. I worked in a Pharmaceutical GMP manufacturing center for injectable drugs. Experienced an FDA audit

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Adding: PHARMACEUTICAL INSPECTION CO-OPERATION SCHEME

PE_009_14_GMP_Guide_Part_I_Basic_Requirements_for_Medicinal_Products_.pdf (312.1 KB)

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For the visual learners.

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For all interested in EU GMP:

EudraLex - Volume 4 - Good Manufacturing Practice (GMP) guidelines

Great resource :muscle:

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Its great to see the Quality Systems / GMP topics discussed here as it impacts almost everyone that manufactures or extracts. I’m a pharma consultant and have been helping several CBD companies over the past year. We will be posting a great deal more information on our website - [https://compliancebydesigns.com/] (https://compliancebydesigns.com/)- this is going to impact everyone so do your homework before the requirements impact your businesses.

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Useful summary article for facilities looking into GMP.

https://mjbizmagazine.com/going-global-join-the-gmp-parade/

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This is a great thread! Thank you so much. This has also really helped me:

https://www.ushempauthority.org/wp-content/uploads/2019/10/USHA-Guidance-Procedures-Version-2.0.pdf

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Thank you for contributing, just attended a good GMP webinar a few hours ago, will upload the link to the webinar when the host shares it. :+1:

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Took awhile for the link to be posted but here it is for anyone interested:

https://www.dnvgl.us/assurance/webinars/food/27032020_CBD_ApprovedSourcing_webinar.html

Heads up: You might need to load your contact details when pulling up the webinar so letting you know ahead of time. The webinar is the 2nd one in a series of two, I would start with the most recent and 2nd video entitled ‘The value of GMP certification’. At 2:20 the US team comes online and at 56:30 the Q&A session started where parts of this was the most useful for me.

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Thank you! Are you currently in the process of building a GMP lab?

This video is a touch dated but still great for anyone investigating equipment validation. The channel also has some great medical devices validation info and the webinar on 21 CFR Part 11 applied to excel spreadsheets is a gem :gem:

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Quick share: Found these 2 webinars to be a nice basic intro on equipment to be qualified into GMP facilities.

https://vitalis.zasso.co/series/GMP_web/basics_GMP

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Every single ISPE document ever created.

Especially Facility Buildout and Rennovations.

They’re hard to find but they’re sitting around somewhere if you google em

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Did anyone else watch the Vanguard Scientific - FDA compliance webinar that was on about an hour ago.

Found the panel discussion and Q&A interesting. Will be sure to share the link when it goes live.

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Do you know if Part 1 is available somewhere?

Yip, sure attached the link below, Password FDA2020. Compared to today’s chat this session was more routine.

https://blog.vanguardscientific.com/demystifying-extraction-webinar-series/episode-1

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