Cannabis, Hemp & CBD | SOP and Procedures

Standard Operating Procedures (SOP) for Cannabis, CBD and Hemp operations are required for every type of business — even if you are only a distributor or marketer. 

Our experts have decades of experience with all types of document requirements, for all types of firms — especially SOP supporting the following:

1. Good Manufacturing Practices (GMP’s)
2. Good Agricultural and Collection Practices (GACP)
3. Good Distribution and Storage Practices

    

Need help with your SOP’s and GMP’s?  Contact us!

Our goal is to help you meet Cannabis, CBD and Hemp regulatory requirements as efficiently as possible.

Farmers are at the root of high quality product, so here’s some free SOP’s for farmers, followed by a sample guidance proposed for cannabis, hemp and CBD agricultural materials (i.e. “Farm SOP’s”)

CANNABIS, HEMP AND CBD FARM SOP LIST

1. Cultivation or Processing
   1. Management
   2. Applicable Regulations
   3. Operations
   4. Training & Safety
   5. Hygiene
   6. Sanitation & Cleaning
   7. Farm or Facility
   8. Equipment
   9. Seeds and Propagation Materials
   10. Agricultural Inputs
   11. Pre-harvest practices
   12. Harvesting
   13. Post-harvest practices
   14. Drying & Milling
   15. Sampling
   16. Testing (Potency, purity, cannabinoids, microbiology, heavy metals, pesticides)
   17. Waste Management

———————

A BASIC EXAMPLE for FARM OPERATIONS

The following information is a partial excerpt from draft from U.S. Hemp Roundtable guidance for CBD products, which NaturPro was fortunate to contribute to.

CBD SOP’s and Cannabis Procedures

U.S. Hemp Guidance Program PHASE 2

1 GROWER
1.1 GENERAL TERMS & DEFINITIONS

The following Definitions and Interpretations apply to such terms when used in this U.S. Hemp Guidance Program.

Adulteration refers to a food that may be considered adulterated if it contains “any poisonous or deleterious substance which may render it injurious to health…..or if any valuable constituent has been in whole or in part omitted or abstracted therefrom; or (2) if any substance has been substituted wholly or in part therefor; or (3) if damage or inferiority has been concealed in any manner; or (4) if any substance has been added thereto or mixed or packed therewith so as to increase its bulk or weight, or reduce its quality or strength, or make it appear better or of greater value than it is”.

Batch means a specific quantity of industrial hemp that is uniform, that is intended to meet specifications for identity, purity, strength, and composition, and that is produced during a specified period of time according to a single manufacturing record.

Batch number, or lot number means any distinctive group of letters, or numbers, or any combination of them, from which the complete history of the processing, packaging, labeling, and/or storage of a batch or lot of industrial hemp product can be determined.

Biomass means the amount of living matter in a given habitat, expressed either as the weight of organisms per unit area or as the volume of organisms per unit volume of habitat.

Component means any substance intended for use in the manufacture of industrial hemp, including those that may not appear in the finished batch of the industrial hemp.

Growth Medium means the solid, liquid or semi-solid substance used to support the growth of the plant.

Hemp refers to cannabis varieties and any part of the plant, whether growing or not, containing a delta-9 tetrahydrocannabinol (THC) concentration of no more than three-tenths of one percent (0.3%) on a dry weight basis.

Industrial Hemp is Hemp
Ingredient means any substance that is used in the manufacture of hemp and that is intended to

be present in the finished batch of the hemp product.

In-process material means any material that is compounded, blended, ground, extracted, sifted, sterilized, derived by chemical reaction, or processed in any way for use in the manufacture of the hemp product.

Lot means a batch, or a specific identified portion of a batch, or, in the case of a hemp product produced by continuous process, a specific identified amount produced in a specified unit of time or

1

U.S. Hemp Guidance Program PHASE 2

quantity in a manner that is uniform and that is intended to meet specifications for identity, purity, strength, and composition.

Microorganisms means yeasts, molds, bacteria, viruses, toxins, and other similar microscopic organisms which may or may not have a health or sanitary concern.

Pest means any objectionable insect or other animal including but not limited to birds, rodents, flies, mites, and larvae.

Physical plant or facility means all or any part of a building or facility used for or in connection with manufacturing, processing packaging, labeling, or storage of industrial hemp products or ingredients.

Processor means making a transformative change to the hemp plant or product following harvest.

Product complaint means any communication that contains any allegation, written, electronic, or oral, expressing concern, which may or may not have be related to the quality of an industrial hemp product.

Quality means that the hemp product meets the established specifications for identity, purity, strength, and composition, and limits on contaminants, and has been manufactured, packaged, labeled, and held under conditions to prevent adulteration.

Quality Management Systems means a planned and systematic operation or procedure for ensuring the quality of a hemp product.

Quality Management Systems personnel means any person, persons, or group, within or outside the organization, designated to be responsible for quality control operations.

Representative sample means a sample with an adequate number of units that are intended to ensure that the sample accurately portrays the material being sampled.

Reserve sample means a representative sample of product that is held for a designated period of time.

Sanitize means to adequately treat cleaned equipment, containers, utensils, etc.by a process that is effective in destroying of microorganisms of public health concerns.

2

U.S. Hemp Guidance Program PHASE 2

1.2 REGISTRATION/APPLICATION/NOTIFICATION

Prior to the Industrial Hemp Grower planting any seed, a license or agreement with the State must be obtained. The following information is required to make the application before a license will be issued: (Each State may have different regulations – refer to application – See Kentucky Hemp Policy Guide as an example)

1.2.1 Registration/Application Guidance

• Name of the person or corporation to whom the license or authorization is to be issued
• Address of the farm or place including county and township or legal description
• The number of acres
• Global Positioning System coordinates
• Intended purpos of industrial hemp
• In the case of a plant breeder, the variety of industrial hemp that may be cultivated; and

o Any conditions that are necessary to minimize security, public health or safety hazards related to the licensed or authorized activities.

o Specify if the hemp is for food or non-food purposes

1.2.2 Notification of Changes to the licensor by the licensee

Every licensee shall notify the State of any changes to the information provided on the application, within 15 days after the change, including:

• Corporate name or ownership, or officers, and the replacement of an officer, or director
• Any change to the address of the licensee
• The replacement of an individual referred to a licensee
• Any change in the mailing address of the licensee
• Any change in the ownership of the land used to cultivate industrial hemp
• Any change to the approved cultivar being sown or, in the case of a plant breeder, to thevariety of industrial hemp being sown;
• Any genetic modification.

Signature: _____________________________ Date: ________________________ Printed Name: __________________________ Company/Location: ________________________

3

U.S. Hemp Guidance Program PHASE 2

1.3 PERSONNEL

Qualified employees who grow, manufacture, package, or label industrial hemp shall be qualified to do so, and those responsible for quality control or performing any quality control operations, must have the education, training, or experience to perform the assigned functions.

Supervisors shall be qualified by education, training, or experience to supervise.
Contamination Prevention and Hygienic measures shall be taken to exclude from any operations

any person who might be a source of microbial contamination.

Such measures shall include the following:

• Exclude personnel from working in any operations that may have an illness, infection, open lesion, or any other abnormal source of contamination.
• Instructing employees to notify their supervisor if there is a possibility that they have a health condition described above.
• Wearing outer garments in a manner that protects against the contamination.
• Maintaining adequate personal cleanliness.
• Washing hands thoroughly, and sanitizing if necessary, in a hand-washing facility.
• Removing or covering all unsecured jewelry and other objects that might fall into components, industrial hemp, equipment, or packaging.
• Using gloves when appropriate.
• Wearing, where appropriate, hair nets, caps, beard covers, shoes, PPE etc.Personnel and employee safety measures shall include the following:

• Appropriate and Adequate First Aid Equipment
• Adequate bathrooms and changing rooms
• Appropriate OSHA warnings, labels, and training
• Appropriate training and personal protective equipment for pesticide application

4

U.S. Hemp Guidance Program PHASE 2

Signature: _____________________________ Date: ________________________ Printed Name: __________________________ Company/Location: ________________________

5

U.S. Hemp Guidance Program PHASE 2

1.3.2 U.S. HEMP GUIDANCE – GROWER – BEST MANAGEMENT PRACTICES CHECKLIST

NOTES

Grower Signature___________________________ Date _________________ Printed Name___________________ Farm location or identifier__________________

6

U.S. Hemp Guidance Program PHASE 2

1.3.3 U.S. HEMP GUIDANCE – GROWER – FACILITY & BIOSECURITY AWARENESS CHECKLISTA.

√ ifApplicable

B.

√ ifApplicable

Visitor Policy

Is the facility using:

YES

NO

NOTES

Company representative for visitor to check in with

Signs informing visitors where to report

Specific area for visitor parking

Records of visitors (include name, company, arrival and departure, and purpose of visit)

Visitor badges/identification cards

Company representative to escort visitor all the time

Restricted access to key manufacturing areas

C.

√ ifApplicable

Distribution

Is the facility implementing the following:

YES

NO

NOTES

Bulk containers are inspected prior to loading for foreign and/or suspicious material

7

U.S. Hemp Guidance Program PHASE 2

D.

√ if Applicable

E.

√ ifApplicable

Housekeeping

Is the facility implementing the following:

YES

NO

NOTES

Written housekeeping program for all areas of the facility

Written pesticide and rodenticide program

Emergency Response

Is the facility implementing the following:

YES

NO

NOTES

Employees are adequately trained to respond to a crisis as calmly and safely as possible

Current inventory of all hazardous and flammable products

A plan to provided MSDS to emergency response teams etc.

A list of emergency contacts is posted

An action plan to deal with suspicious devices or substances

Evacuation plan in case of fire and explosions is published

Establish and maintain an up-to-date employee roster and visitor log to facilitate personnel head count at any time

Disaster Preparedness Plan

A weapons security program

Conduct evacuation and respond drill periodically

Post a site plan depicting escape routes, fire-fighting and rescue equipment

Signature: _____________________________
Printed Name: __________________________ Company: ________________________________

Date: ________________________________ Facility Location: ________________________________8

U.S. Hemp Guidance Program PHASE 2

1.4 SAMPLING AND HANDLING HEMP FOR THC & CBD1.4.1 Definitions

delta-9-THC means delta-9-tetrahydrocannabinol concentration.
Authority having jurisdiction usually means the state, but it could be FDA, USDA,

county or city.

Certified seed means seed for which a certificate or any other instrument has been issued, by an agency authorized under the laws of a state, territory, or possession to certify seed and which has standards and procedures approved by the United States Secretary of Agriculture to ensure the genetic purity and identity of the seed certified.

Plot means a contiguous area in a field, greenhouse, or indoor growing structure containing the same variety or strain of hemp throughout the area.

ppm means parts per million.ppb means parts per billion.

Post-Harvest Sample means a sample taken from the harvested hemp materialfrom a particular plot’s harvest. The entire plot’s harvest must be in the same form(e.g., intact-plant, flowers, ground materials, etc.), homogenous, and not mixed with non-hemp materials or hemp materials from another plot.

Pre-Harvest Sample means a composite, representative portion from plants in a hemp plot collected in accordance with the procedures as defined by the state providing authority.

Processing means converting an agricultural commodity into a marketable form.Prohibited Variety means a variety or strain of cannabis excluded from the state

providing authority.

Sample means a sufficient amount of material that is representative of the population from which it is taken. A sample may be a particular plant part, including inflorescence (flower), leaf, stalk or seed, or it may be a processed product (oil, extract, powder. Samples must be dried to a sufficiently low moisture content so as not to harbor growth of microorganisms.

Seed source means the origin of the seed or propagules as determined by the state providing authority.

9

U.S. Hemp Guidance Program PHASE 2

2. 1.4.2  Sampling Timeline and Grower Responsibilities
   1. The grower shall refer to the jurisdiction having authority to determine a timeline.
   2. During the sampling, the grower or an authorized representative shall be present at the growing site.
   3. Floral materials harvested for phytocannabinoid extraction shall not be moved beyond the processor, nor commingled, nor extracted, until test results are complete
3. 1.4.3  Pre-Harvest Sampling Procedure
   1. Adequate personal protective equipment shall be used.
   2. Proper equipment shall be used to prevent cross contamination.
   3. The material selected for Pre-Harvest Sampling will be determined by the grower. Cuttings will be collected to make one representative sample.
   4. Refer to the authority having jurisdiction to determine adequate number of samples and proper locations. In the absence of jurisdictional requirements, the following guidance is given.
      1. Clip the top 12 inches of hemp plant’s primary stem, including female floralmaterial.
      2. Take cuttings from at least five (5) hemp plants within the plot.
      3. Place the complete sample in a paper bag.
      4. Seal the bag by folding over the top once and staple the bag shut.
      5. A separate sample must be taken from each non-contiguous plot of a given variety.
      6. A separate sample must be taken for each variety.
      7. Samples shall be secured in a paper bag (to allow for air-drying during transport).
      8. Label the sample container with a sample ID.
4. 1.4.4  Handling Procedures of Pre-Harvest Samples
   1. Samples will be taken for drying and storage.
   2. Samples should be arranged in a single layer for drying.
   3. Drying oven will be used when possible.
   4. Samples in the oven will be left in the labeled sample bag.
   5. If selected for testing, the entire sample will be sent to a testing lab for analysis.
5. 1.4.5  Post-Harvest Sampling Procedures for Floral Material
   1. Refer to the authority having jurisdiction to determine adequate number of samples and proper locations. In the absence of jurisdictional requirements, the following guidance is given.
   2. Adequate personal protective equipment shall be used.
   3. Proper equipment shall be used to prevent cross contamination
   4. The plot selected for sampling shall be designated by the Pre-Harvest Sampleresults. The material selected for Post-Harvest Sampling from this plot will be

10

U.S. Hemp Guidance Program PHASE 2

determined by the grower. All Post-Harvest Samples of floral material shall be taken from the designated harvested plot materials in the form (intact-plant, flowers, ground materials, etc.) in which the material will be sent to the processor

e. Grower must inventory the entire harvest to determine the form in which it exists and follow the protocol as appropriate in part a), b), or c) below.

1. If, upon inventory, the grower determines that the entire harvest is not in a homogenous form (intact-plant, flowers, ground materials, etc.), it must be determined to take additional samples or other course of action or take the pre-harvest results.
2. For intact-plant post-harvest samples:
   1. Ensure that the entire harvest is accounted for and in the sameform (i.e., intact-plants).
   2. Clip the top 12 inches) of hemp plant, primary stem, includingfemale floral material.
   3. Take cuttings from at least five (5) non-adjacent hemp plantswithin the harvest’s storage/drying area.
   4. Place the complete sample in a paper bag.
   5. Seal the paper bag by folding over top once and stapling to keep closed.
   6. Complete sampling procedures in part (d) –(f).
3. For ground plant or ground floral material Post-Harvest Samples:
   7. Ensure that the entire harvest is accounted for and in the sameform (i.e., all harvested material whether whole plant or floral material only must be ground with no intact plants or whole flowers remaining from that harvest).
   8. Sample material from bag or container.
   9. Sample from a minimum of four locations within the containers from a given harvest.
   10. Place the complete sample in a plastic sample container.
   11. Seal the plastic sample container.
   12. Complete sampling procedures in part (d) –(f).
4. For Post-Harvest Samples in other forms (e.g., trimmed floral material, or floral material and stems, etc.):
   13. Ensure that the entire harvest is accounted for and in the same form (i.e., all harvested material must be uniform).
   14. Randomly collect at least one cup of material by volume.
   15. Place the complete sample in a paper bag or plastic containerand seal the container, as appropriate.
   16. Complete sampling procedures in part (d) –(f).
5. A separate sample must be taken for each plot designated for Post-Harvest Sampling.
6. Samples shall be labeled and prepared for transport to the lab.
7. Label the sample container with a sample ID.

11

U.S. Hemp Guidance Program PHASE 2

1.4.6 Handling Procedures of Post-Harvest Samples

1. The entire sample will be sent to the testing lab for analysis.
2. Industrial hemp crops generated from Certified seed will incur pre-harvest testing of at least five percent (5%) of growing plots per variety, per seed source.
3. Industrial hemp crops from planting materials other than Certified seed will incur pre- harvest testing of at least fifty percent (50%) of growing plots per variety, per seed source.
4. 100% of post-harvest samples will be tested.