Form MJ CS-001 "Control Study Certification Form" - Oregon

What Is Form MJ CS-001?

This is a legal form that was released by the Oregon Liquor Control Commission - a government authority operating within Oregon. As of today, no separate filing guidelines for the form are provided by the issuing department.

Form Details:

  • Released on January 4, 2021;
  • The latest edition provided by the Oregon Liquor Control Commission;
  • Easy to use and ready to print;
  • Quick to customize;
  • Compatible with most PDF-viewing applications;
  • Fill out the form in our online filing application.

Download a fillable version of Form MJ CS-001 by clicking the link below or browse more documents and templates provided by the Oregon Liquor Control Commission.

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Download Form MJ CS-001 "Control Study Certification Form" - Oregon

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Control Study Certification Form
Form Instructions
What is this form?
The purpose of a control study is to determine if a manufacturer is using standard operating procedures (SOP) that result
in a finished cannabinoid concentrate, extract or product that is homogeneous, and for cannabinoid products meets the
potency target identified in the SOPs.
This is the form a manufacturer submits to obtain a certified control study. Manufacturers who may use this form include
recreational marijuana processors, micro-tier producers with the concentrate processing endorsement, producers making
kief, and hemp handler certificate holders requesting testing on products that are tracked in Metrc. Wholesalers may
arrange testing on behalf of other licensees, but this form must be completed by the product manufacturer.
INSTRUCTIONS for completing this form:
The product manufacturer completes and signs pages 1 and 2 and provide them to the laboratory when requesting
compliance testing for the batch.
After performing compliance testing, the primary laboratory completes page 3, then submits the form to
OLCC.Labs@oregon.gov. Do not provide a copy of test results or SOP unless requested. Associated test results or
other documentation may be requested by the Commission to verify the responses contained in this form.
Every section of this form must be completed legibly. Incomplete or illegible forms will be returned to the licensee
and will not be reviewed by OLCC until deficiencies are corrected.
No blanks should be left in the form. The manufacturer or laboratory representative completing this form should
write “Not Applicable” or “NA” in any section they believe is not applicable to the testing of the particular product. If
blank spaces are left in the form, or the Commission determines that a “Not Applicable” or “NA” response is not
appropriate for a particular section, the form will be returned to the licensee and will not be reviewed by OLCC until
.
the deficiencies are corrected
The control study is invalidated and the product manufacturer must undergo a control study for a product again or
must have batches sampled and tested as if the product had not undergone a control study if:
o
There are any changes to the standard operating procedures for that product;
o
There are any changes in the type of ingredient in the product, except for a difference in the strain of usable
marijuana, or the purity of an ingredient; or
o
A batch tested under the control study fails a THC or CBD test as described in OAR 333-007-0440(10)(b).
If a control study is invalidated for any reason listed in 333-007-0440(10) then a manufacturer must notify the
OLCC.
This form and OAR
333-007-0440
refer to standard operating procedures (SOPs). The certification of a control study is
based on the SOP and is invalidated if the manufacturer makes and changes to the SOP other than as allowed under
OAR 333-007-0440(11). Note that OLCC rules (OAR 845-025-3230) require processors to maintain written policies and
procedures that include:
Instructions for making each cannabinoid concentrate, extract or product;
The ingredients and the amount of each ingredient for each process lot;
The process for making each product;
The number of servings in a process lot;
The intended amount of THC per serving and in a unit of sale of the product; and
The process for making each process lot homogeneous.
Control Study Certification Form
Form Instructions
What is this form?
The purpose of a control study is to determine if a manufacturer is using standard operating procedures (SOP) that result
in a finished cannabinoid concentrate, extract or product that is homogeneous, and for cannabinoid products meets the
potency target identified in the SOPs.
This is the form a manufacturer submits to obtain a certified control study. Manufacturers who may use this form include
recreational marijuana processors, micro-tier producers with the concentrate processing endorsement, producers making
kief, and hemp handler certificate holders requesting testing on products that are tracked in Metrc. Wholesalers may
arrange testing on behalf of other licensees, but this form must be completed by the product manufacturer.
INSTRUCTIONS for completing this form:
The product manufacturer completes and signs pages 1 and 2 and provide them to the laboratory when requesting
compliance testing for the batch.
After performing compliance testing, the primary laboratory completes page 3, then submits the form to
OLCC.Labs@oregon.gov. Do not provide a copy of test results or SOP unless requested. Associated test results or
other documentation may be requested by the Commission to verify the responses contained in this form.
Every section of this form must be completed legibly. Incomplete or illegible forms will be returned to the licensee
and will not be reviewed by OLCC until deficiencies are corrected.
No blanks should be left in the form. The manufacturer or laboratory representative completing this form should
write “Not Applicable” or “NA” in any section they believe is not applicable to the testing of the particular product. If
blank spaces are left in the form, or the Commission determines that a “Not Applicable” or “NA” response is not
appropriate for a particular section, the form will be returned to the licensee and will not be reviewed by OLCC until
.
the deficiencies are corrected
The control study is invalidated and the product manufacturer must undergo a control study for a product again or
must have batches sampled and tested as if the product had not undergone a control study if:
o
There are any changes to the standard operating procedures for that product;
o
There are any changes in the type of ingredient in the product, except for a difference in the strain of usable
marijuana, or the purity of an ingredient; or
o
A batch tested under the control study fails a THC or CBD test as described in OAR 333-007-0440(10)(b).
If a control study is invalidated for any reason listed in 333-007-0440(10) then a manufacturer must notify the
OLCC.
This form and OAR
333-007-0440
refer to standard operating procedures (SOPs). The certification of a control study is
based on the SOP and is invalidated if the manufacturer makes and changes to the SOP other than as allowed under
OAR 333-007-0440(11). Note that OLCC rules (OAR 845-025-3230) require processors to maintain written policies and
procedures that include:
Instructions for making each cannabinoid concentrate, extract or product;
The ingredients and the amount of each ingredient for each process lot;
The process for making each product;
The number of servings in a process lot;
The intended amount of THC per serving and in a unit of sale of the product; and
The process for making each process lot homogeneous.
OREGON LIQUOR CONTROL COMMISSION
Control Study Certification Form
OAR 333-007-0440
Section 1 – Business Information
Manufacturer Name:
License or Certificate Number:
Email:
Name of Manufacturer Representative Who Completed This Form:
Section 2 – Product Information
Commercial Name of Item:
Concentrate
Extract
Cannabinoid Product
Item Category:
(Skip Section 4)
(Skip Section 4)
(Skip Section 3)
SOP Name or Reference:
SOP Version:
SOP Date
(Created or Revised)
:
Item is Intended to be “Medical Grade” Potency?
:
(OAR 333-007-0220)
Yes
No
N/A
Does This Item Contain Marijuana?
:
(For hemp-only items, see OAR 845-025-2760)
Yes
No
Item Texture:
Solid
Liquid
Gas
Other:
Section 3 – Concentrate or Extract Item Information
If the item is a cannabinoid product, skip this section.
For sale to consumer
Item is Intended for:
Process Lot (Batch) Weight:
grams
(Check any that apply)
For further processing
Compliance Tests Performed:
Solvents
Pesticides
Potency
If item is not intended for sale to consumers, skip the following line
Unit of Sale Weight:
grams
Number of Servings per Unit:
Section 4 – Cannabinoid Product Item Information
If the item is a concentrate or extract, skip this section.
Process Lot (Batch) Size:
units
Target THC per Unit of Sale:
mg
Unit of Sale Weight:
grams
Number of Servings per Unit:
Edible
Tincture
Capsule
Metrc Category:
Infused Pre-roll
Topical
Suppository
(Select one)
Combined Category
Hemp Cannabinoid Product
[FORM MJ CS-001]
(rev 20210104) Page 1 of 3
Control Study Certification Form
OREGON LIQUOR CONTROL COMMISSION
Control Study Certification Form
OAR 333-007-0440
Section 5 –Variations
Use this section to describe any variation of the item that would be permitted under OAR 333-007-0440(11) that you
intend to qualify for reduced sampling and testing once the control study is certified.
Item variations cannot result from changes in the SOP. Making changes to the SOP invalidates the certification of
a control study.
Cannabinoid Products only
Will you make variations that use different flavors or colors that do not have an
Yes
No
N/A
effect on the potency of the finished cannabinoid product?:
Will you make item variations that vary in the size of the unit of sale?:
Yes
No
N/A
(If Yes, use the following lines to list each variation in the unit of sale)
Unit of Sale Weight:
Variation #1
grams
Number of Servings per Unit:
Unit of Sale Weight:
Variation #2
grams
Number of Servings per Unit:
Unit of Sale Weight:
Variation #3
grams
Number of Servings per Unit:
Unit of Sale Weight:
Variation #4
grams
Number of Servings per Unit:
Unit of Sale Weight:
Variation #5
grams
Number of Servings per Unit:
Will you make any other kinds of variations allowed under OAR 333-007-0440(11):
Yes
No
(If Yes, describe the variations in the space below)
Section 6 – Manufacturer Attestation
I have reviewed all information submitted in Sections 1 through 6 of this form. All information submitted is true and correct to
the best of my knowledge. I attest that every variation listed is permitted under OAR 333-007-0440(11) and does not involve a
change in the standard operating procedures. I understand that the products listed under this control study must continue to
meet these standards for the duration of the Control Study certification and that failure to comply with any of the applicable
rule requirements may result in an administrative sanction.
By signing my name below, I affirm that this form has been evaluated by myself or by an employee, agent, or other
representative acting on my behalf. I understand that submitting false or misleading information to a laboratory is a violation
of administrative rule. I understand I must notify OLCC if any condition occurs that invalidates the certification of this control
study.
Signature:
Date:
[FORM MJ CS-001]
(rev 20210104) Page 2 of 3
Control Study Certification Form
OREGON LIQUOR CONTROL COMMISSION
Control Study Certification Form
OAR 333-007-0440
Section 7 – Laboratory Information
Laboratory Name:
License Number:
Email:
Name of Laboratory Representative Who Completed This Form:
Section 8 – Potency Results
If the item is a concentrate or extract that did not undergo compliance testing for potency, skip this section.
Highest Sample Concentration
Lowest Sample Concentration
RSD
Detected THC Range:
mg/g
mg/g
%
Highest Sample Concentration
Lowest Sample Concentration
RSD
Detected CBD Range:
mg/g
mg/g
%
For cannabinoid products intended to contain at least 10 mg THC per unit of sale
= 1.2 × THC
÷ Weight
unit
unit
What is the threshold where a sample exceeds the target THC potency by 20%?
mg/g
N/A
Did any sample exceed the manufacturer’s target THC potency by 20% or more?
Yes
No
N/A
For items subject to the potency limits specified in OAR
333-007-0210
or
333-007-0220
= 1.1 × THC
÷ Weight
limit
unit
What is the threshold where a sample exceeds the THC concentration limit by 10%?
mg/g
N/A
Did any sample exceed the THC concentration permitted in a package by 10% or more?
Yes
No
N/A
Section 9 – Laboratory Attestations
OLCC will not certify the control study unless all of the following boxes are checked. If any of the following statements are not true, this
item has not met all of the conditions for passing a control study.
By checking the boxes below, I certify that:
The number of sample increments taken meet the requirements of OAR 333-007-0360, Exhibit B.
Pesticide testing results for each sample were below the action limits set in Exhibit A, Table 3 to OAR 333-007-0400; or
Pesticide testing was not required and was not conducted.
The Limit of Quantification (“LOQ”) for each pesticide tested for was below the action limits set in Exhibit A, Table 3 to
OAR 333-007-0400; or
Pesticide testing was not required and was not conducted.
All solvents listed in Exhibit A, Table 4 of OAR
333-007-0410
were tested for; or
Solvent testing was not required and was not conducted.
All solvents test results for each sample were below the action limits set in Exhibit A, Table 4 of OAR 333-007-0410; or
Solvent testing was not required and was not conducted.
The Limit of Quantification (“LOQ”) for each solvent was below the action limits set in Exhibit A, Table 4 to OAR
333-
007-0410; or
Solvent testing was not required and was not conducted.
The Relative Standard Deviation (RSD”) among total THC results and among total CBD results is below 20%; or
Potency testing was not required and was not conducted.
For official OLCC use only
OLCC’s certification of this form is entirely conditioned on the accuracy of the information provided by the manufacturer and the laboratory
who completed this form. Submitting false or misleading information to the Commission is a violation of Oregon Administrative Rules.
Certification #:
Control Study Expires On*:
Processed by:
*Unless invalidated prior to this date
[FORM MJ CS-001]
(rev 20210104) Page 3 of 3
Control Study Certification Form
Page of 4