The Ultimate Guide to SOPs for the Cannabis Industry: Part II

In the first part of the Ultimate Guide to Cannabis SOPs, we reviewed what SOPs are, why SOPs for cannabis matter, and provided some tips for writing SOPs for cannabis and implementing them in your cannabis business plan. If you haven't read the first primer, stop and review it now. Part Two of this guide elaborates on the different types of SOPs and quality programs that are vital to success and compliance in the cannabis industry.

There are many different procedures that take place during the production process. Knowing how to break them up into smaller processes can be difficult, but it is important to ensure a balance between SOPs that are too long and having too many. SOPs will generally fall under larger umbrella categories such as production, operations, and quality assurance. 

The most important part of SOPs for cannabis is that they meet the necessary regulatory requirements. These requirements vary considerably among US states, but Canada has provided much clearer requirements called Good Production Practices (GPP), which share common themes with Good Manufacturing Practices (GMP).

Standard operating procedures for cannabis cultivation describe the production environment, the equipment used, environmental controls, and how plants are managed and cared for at each stage of growth. Some important details to include in cannabis cultivation SOPs include:

• Soil or other growth medium used
• Lighting schedule
• Temperature and humidity controls
• Defoliation and pruning method and frequency
• Watering frequency and amount
• Nutrient formulas and application
• Identifying problems such as nutrient deficiency, pests, and pathogens

Cultivation is just one aspect of cannabis production. Other activities such as storage, labelling, packaging, and post-harvest processing need to have SOPs as well. One very important requirement in cannabis production is that all plant material must be accounted for. Weights of plant material must be carefully tracked using calibrated scales.

Packaging and labelling have strict legal requirements that slightly vary by jursidiction. In many areas childproof, tamper evident, and opaque packaging may be required. Packaging materials for cannabis should also be tested to ensure they do not introduce microbial contamination or shed foreign material. 

Labels for cannabis products need to contain important details like batch number, manufacturer name and location, ingredients used in preparation and cultivation, health and safety warnings, and potency. A plan for labelling control should be in place and detail how labels are verified for accuracy before use. Copies of labels should also be retained in case there is an issue that is identified.

SOPs for cannabis storage should describe how materials are segregated based on their quarantine status. Approved materials should be clearly separated from quarantined materials. Before approving materials, they may need to be tested or have paperwork or certifications reviewed by a manager or quality assurance officer.

A cannabis storage SOP should also elaborate security measures that are in place and how access to materials in storage is restricted to as few employees as possible. Environmental conditions are also important for storage as temperatures that are too high or low can deteriorate the quality of cannabis material, nutrients, and even some packaging materials.

Cannabis products require testing for parameters like potency, microbial contamination, pesticides, and heavy metals. SOPs are needed to document testing procedures. It is especially important that test material is mixed prior to sampling, that sampling is performed the same way every time, and that there is a clear criteria for acceptable limits.

Water quality testing is also very important in cannabis cultivation since it can influence nutrient solution preparation. Cannabis also readily takes up heavy metals, so water used for irrigation needs to be free from contaminants. Irrigation water can also introduce pests and pathogens. Microbial testing can help ensure water is safe for plants and for workers that are exposed to it.

The third type of testing that should be covered in standard operating procedures is environmental monitoring. Environmental monitoring quantifies the amount of bacteria and fungi that are present in the production space. From initial studies, problem areas and high traffic areas where microbes could thrive and spread are identified. Petri dishes and swabs are used to sample these areas and make sure that microbial levels stay within safe limits. Environmental monitoring can be costly, but without an environmental monitoring program there is no way to validate sanitation procedures. Environmental monitoring is key to ensuring products are safe and sanitary.

When it comes to testing SOPs, it is best to work closely with the laboratories that will be doing the testing. The laboratories should be able to provide sufficient information on their testing methods to be sure they meet regulatory standards. Labs should also advise on how samples should be taken and how they should be shipped to ensure their integrity is preserved. Improper sampling is a huge issue facing the industry that adds to the problem of inter-laboratory variation. Be sure to work with laboratories that are accredited and transparent.

Traceability is one of the most fundamental and important criteria of cannabis regulation. All cannabis material must be tracked from seed to sale. ERP systems like GrowerIQ are the best way to achieve traceability. Along with using ERPs for inventory control and batch tracking there need to be SOPs to guide the use of the ERP and related tasks such as batch numbering and moving materials between storage locations.

Sanitation plans for the cannabis industry should detail cleaning procedures and products used. A sanitation schedule accompanies the sanitation SOP and details when cleaning will take place and the rotation of cleaning products to be used. Cannabis facility and equipment maintenance should also be detailed in an SOP.

Employee health and hygiene can be an awkward topic, which is all the more reason to outline requirements in an SOP. Employee health and hygiene is an essential part of a sanitation plan as contamination can enter facilities through shoes and clothing worn in to work. 

Waste management is an important procedure in the cannabis industry because all plant material needs to be thoroughly accounted for. Major legal issues may arise if cannabis waste disposal is not well documented and performed properly according to local regulations.

Even small cannabis businesses will benefit from having at least one dedicated Quality Assurance Officer. A Quality Assurance Officer performs verifications, reviews records, and helps to manage the Quality Management System. Experienced quality assurance personnel have a deep understanding of how government entities interpret regulatory codes and can implement measures to ensure compliance. Quality assurance for cannabis does not differ much from quality assurance for other industries. Experience in the pharmaceutical, medical device, and biotechnology industry are advantageous qualifications to look for in a quality assurance candidate.

In addition to performing record review and process verifications, quality assurance staff are responsible for document control, risk assessment, and overseeing testing. In collaboration with management, they help to control quarantine status for storage and inventory control, and oversee cannabis waste destruction. They are also the ideal employee to manage the bulk of the cannabis SOPs for the business.

Several SOPs are needed for quality assurance for cannabis. Pre-requisite SOPs and programs heavily involve quality assurance and build the foundation of a Quality Management System. The processes associated with the responsibilities of a quality assurance officer must all have SOPs. That includes document control, record review and retention, and risk assessment. Some other SOPs that should be part of the Quality Management System include:

• Good Documentation Practices (GDP)
• Data Integrity Policy
• Corrective Action and Preventive Action
• Hazard Analysis and Critical Control Points (HAACP plan)
• Complaint Handling
• Recalls and Returns
• Planned and Unplanned Deviations
• Electronic Documentation
• Post Market Surveillance
• Vendor Qualification
• Receipt of Master Production Documents
• Self Inspection
• Annual Product Quality Review
• Batch Release for Distribution

Training programs are very important and are required by GMP regulations. Having a clear training program ensures that all employees have been properly trained for the work they perform. Logs should be retained as proof that employees have been trained. Documented training on safety and hygiene are also required by OSHA (US Occupational Safety & Health Administration).

Security is very important in the cannabis industry. Cannabis businesses must protect their products from theft and adulteration. They must also protect their records and electronic data along with proprietary information. This starts with having an ethics policy and non-disclosure agreements with employees. Employees need to be vetted to ensure that they are not a security risk, and they must also be trained and educated on how to perform their jobs without introducing security risks. 

Security plans should also overlap with storage procedures. All cannabis material should be stored in a vault or other secured area that is carefully monitored. Access to stored cannabis material should be highly restricted and monitored. Security SOPs for cannabis should elaborate the measures taken to protect the product and facility from security risks. This includes:

• Type of alarms
• Security surveillance equipment
• Lighting and perimeter monitoring
• Record keeping security to prevent fraud
• Security personnel
• Employee identification
• Limited access areas and secure storage

ERPs like GrowerIQ are amazing tools that aid in record keeping and inventory control.  Procedures are needed to ensure electronic systems are properly used and maintained in a way that complies with regulation. Traceability needs to be maintained through electronic systems, they must also be secure, and be able to uniquely identify users.

While GrowerIQ allows for indefinite document retention, paper systems will require secure storage for retention periods that can be anywhere from two to ten years depending on the type of document and regulatory code. Records include forms and logs, audits, results from testing, shipping records, and more. A record keeping SOP needs to address the following points:

• Which records are retained?
• How long are records retained?
• Who is responsible for archiving records?
• Who has access to the record archive?
• How are records secured?
• How and when are records disposed of?

Safety SOPs are important for compliance with OSHA policies and labor laws. Safety SOPs are also important for pest management and chemical handling. Some key points that these SOPs need to cover include how hazardous materials are stored, handled, and disposed of safely and in compliance with local law, how hazardous materials are used and how worker safety is ensured through the process of using them. Personal protective equipment (PPE) plays a major role in ensuring worker safety and product safety. Safety training and pesticide training should take place annually and during onboarding for new employees.

Pre-requisite programs are procedures that build a foundation to sound operations. These minimum conditions aim to protect the quality and safety of cannabis products. In addition to basic SOPs, these programs need to be in place to prevent potential hazards from impacting the safety of the product. Some examples of PRPs are:

• Document Control
• Supplier Verification Programs
• Raw Material Receiving (ingredients, processing aids and packaging)
• Good Manufacturing Practices (GMPs)
• Preventative Maintenance (PM) Program
• Calibration Program
• Integrated Pest Management (IPM)
• Environmental Monitoring Programs
• Water Management Programs
• Allergen Management Program
• Standard Sanitation Operating Procedures (SSOPs)
• Standard Operating Procedures (SOPs)
• Crisis Management
• Traceability
• Recall
• Waste Management

In addition to standard operating procedures, every cannabis business should have employee handbooks. Employee handbooks are essential to compliance with labor laws and make sure employees have a clear and documented understanding of expectations. Don’t forget to cover these subjects in the employee handbook for your cannabis business:

• An "employment at will" disclaimer
• An anti-harassment policy
• An internal grievance procedure
• Equal Employment Opportunity (EEO)
• Employee benefits
• Paid time off (vacation, personal days, sick leave)
• Unpaid leaves of absence
• Americans with Disabilities Act (ADA) (for employers with more than 15 employees)
• Jury duty, military leave
• Hours of work
• Introductory/probationary period
• Legally mandated language concerning pay deductions
• Proper E-mail/Internet usage
• Professionalism/dress code
• Drugs in the workplace
• Social media policy