GMP Fundamentals – Process Considerations For Chapter 19, Q7
Dr. Jon Thompson brings us through his Good Manufacturing Practices (GMP) Fundamentals and considerations in product and process procedures within the cannabis industry. In this episode he sheds light on ICH Guidelines on Chapter 19, Q7 and it’s impact on facility design.
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[00:00] – A Million Views
[01:00] – GMP Series
[05:25] – ICH Guidelines
[06:11] – Chapter 19, Q7
[07:25] – Stages of Process Development
[08:54] – Equipment Guidelines
[11:19] – Established Specifications
[12:00] – Intended Use of The Extractor.
[17:43] – Dirty Little Secret About The Vacuum
[19:47] – Tragic Explosion
[20:23] – Qualified Operating Range
[22:00] – Identification.
[23:30] – No Detrimental Effects
[25:00] – Risk Assessment
[28:45] – What We Do