BEST PRACTICES (AND PITFALLS) OF CANNABIS CULTIVATION - Copyright TheraCann International, February 2019
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BEST PRACTICES (AND PITFALLS) OF CANNABIS CULTIVATION Copyright ©TheraCann International, February 2019
2
CANNABIS
REGULATORY
FRAMEWORKS
Seek to measure and
control cannabis
quality without
addressing
systemic issues
By Jamesy0627144 - Created from BlankMap-World6-Subdivisions.svg and BlankMap-
related to root World6.svg,
CC BY-SA 4.0, https://commons.wikimedia.org/w/index.php?curid=71440365
causes of variation
in Standard INTRO:
Operating In order for Latin America to maximize its value for cannabis raw
material and fnal product, strict control over cannabis root causes
Procedures (SOP’s). of variation are required.
S T R I C T LY P R I VAT E & C O N F I D E N T I A L
3
WHAT IS THE PRODUCT MARKET?
Medical?:
Variation = recall
Recreational?:
Variation = celebration
4
4
CULTIVATION
OUTDOORS INDOORS
Sun intensity and duration
Soil nutrients
●
Controlled Light
Soil moisture
●
Controlled nutrients
Air humidity
●
Controlled moisture
Air temperature
●
Controlled air humidity
CO2 Level
●
Controlled air temp
Biological / pests contaminants
●
Controlled CO2 level
Herbicide / pesticide
●
Controlled biological / pests
Other
●
Controlled herbicide / pesticide
●
Other
S T R I C T LY P R I VAT E & C O N F I D E N T I A L
5
5
PROCESSING
DRIED FLOWER OIL CONCENTRATE
Harvest handling process
Air Dry / Freeze Dry technology ●
Harvest handling process
Dry / Cure process ●
Extraction technology
Duration ●
Extraction process
Air humidity ●
Solvent used
Air temperature ●
Temperature / Pressure
Air quality ●
Wax Management
Biological / pests control ●
Air quality
Product stability ●
Biological / pests control
Other ●
Product stability
●
Other
S T R I C T LY P R I VAT E & C O N F I D E N T I A L
6
6
PACK AND LABEL
MANUAL AUTOMATED
Packing process ●
Packing process
Duration ●
Equipment maintenance
Air / Biological / pests control ●
Equipment complexity
Calibration of weight / quality ●
Equipment operating perimeters
Quality of Additives ●
Air / Biological / pests control
Product stability ●
Product stability
Packaging sterility ●
Packaging sterility
Packer training / hygiene ●
Packer training / hygiene
Other ●
Other
S T R I C T LY P R I VAT E & C O N F I D E N T I A L7
7
Lab Analysis – 17025 (2017)
ANALYSIS NOT CERTIFIED
NON-ACCREDITED
●
Cannabis is not wheat/oats/barley
Apples to oranges lab methods ●
Lab equipment selection
Accuracy / precision ●
Method validation
Record keeping ●
Method detection limits (MDL’s)
Non-conformance handing ●
Equipment operating perimeters
Calibration Handling ●
Operator experience
Cross Contamination ●
Calibration standard selection
One over one review ●
Report verification
Lab shopping for results ●
Whistle blower procedure
Other ●
Other
S T R I C T LY P R I VAT E & C O N F I D E N T I A L8
TO MANY ROOT CAUSES TO COUNT = POOR QUALITY
6 Σ = 6 defects per million products
5 Σ = 230 defects per million products
4 Σ = 6,210 defects per million products
3 Σ = 66,300 defects per million products
2 Σ = 308,000 defects per million products
1 Σ = 690,000 defects per million products
You cannot manage what you do not measure!
S T R I C T LY P R I VAT E & C O N F I D E N T I A L9
AVERAGE CANNABIS Σ = 2.2 = 242,000 DEFECTS PER MILLION
6 Σ = 6 defects per million products
5 Σ = 230 defects per million products
4 Σ = 6,210 defects per million products
3 Σ = 66,300 defects per million products
2 Σ = 308,000 defects per million products
1 Σ = 690,000 defects per million products
And what we are measuring is only part of the story!
S T R I C T LY P R I VAT E & C O N F I D E N T I A L10
10
FIRST PASS vs. SECOND PASS YIELDS
FIRST PASS SECOND PASS
Loss of crop not recorded
Sample used not representative
Solution is dilution
Absence of method validation study
Use of sterilization tech fails to adequately
Lack of tracking diversion record product variation
Sample frequency
Sample homogeneity
When taken together in addition to existing Σ = ??? >2.1!
S T R I C T LY P R I VAT E & C O N F I D E N T I A L11
11
ACCEPTABLE RANGE OF VARIATION?
MEDICAL GRADE CONSUMER GRADE
Σ = 4-5
Σ = 2-3
S T R I C T LY P R I VAT E & C O N F I D E N T I A L12
12
A BETTER WAY TO MEASURE /
MANAGE IS POSSIBLE
{ +13
SOP’S NECESSARY FOR MANAGING CANNABIS
With too many potential root causes of variation
requires a REPSS approach:
Repeatable (able to fex to new conditions)
Economic (both for Regulator and LP)
Practical (simple to implement and comply)
Safe and Secure(manages diversion and quality)
SOPs must be part of the actual ERP+C itself:
only way to accurately record variation
best way to manage correcting action
only reliable way to manage version control!
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