CSQ Extraction Overview
1.1. Introduction
The CSQ Standard for Extraction (CSQ – Extraction) meticulously governs the comprehensive CSQ Certification Program, ensuring adherence to stringent safety and quality parameters within the cannabinoid industry.
It specifically encompasses the crucial audit requirements for all licensed operations involved in the processing and production of cannabinoid substances, from raw material handling to final product. This includes detailed guidelines for facilities, equipment, personnel, and processes.
This essential document is structured to provide a complete framework, including:
CSQ Standard for Extraction Overview: An introductory section explaining the purpose, scope, and management of the standard.
CSQ Standard for Extraction Audit Requirements: Detailed modules outlining specific compliance criteria for various operational aspects.
Appendixes: Supplementary information, definitions, and reference documents crucial for full compliance and understanding.
The development of this standard is rigorously based on well-established international benchmarks, such as ASTM International standards, ISO (International Organization for Standardization) guidelines, current Good Manufacturing Practices (cGMP), Hazard Analysis Critical Control Points (HACCP) principles, and guidelines from the American Herbal Products Association (AHPA). This multi-faceted approach ensures a robust and globally recognized standard.
Any updates or revisions to the standard are proactively communicated to all relevant stakeholders, including certified operations, auditors, and regulatory bodies, and are made publicly accessible to ensure transparency and continuous improvement.
1.2. Ownership and Management
The CSQ Certification Program and its accompanying Standards are exclusively owned and managed by ASI Global Standards, LLC.
Their corporate address is located at: 500 NW Plaza, Suite 700 St. Ann, MO 63074, which serves as the central hub for the program's governance.
ASI Global Standards retains full ownership of all official CSQ program documents and holds comprehensive agreements with all involved certifying bodies, accreditation bodies, and authorized training organizations. This centralized ownership ensures consistency and integrity across the entire certification ecosystem.
The day-to-day management and operational oversight of the CSQ Certification Program are meticulously handled by the designated CSQ Certification Program Owner, who is responsible for implementation, compliance, and ongoing program efficacy.
1.3. CSQ Standard for Extraction Scope
The standard rigorously conforms to current Good Manufacturing Practices (cGMP), establishing a comprehensive framework that addresses both safety and quality management throughout the entire production lifecycle of cannabinoid substances.
It broadly applies to the production of cannabinoid substances derived from any cannabis plant, irrespective of its legal classification (e.g., hemp or marijuana), covering a wide array of products, including:
Glandular trichomes (resin glands) and their unprocessed forms.
Cannabinoid concentrates and extracts, which involve various extraction and concentration techniques.
Isolated and purified cannabinoids, such as CBD or THC isolates, implying advanced refinement processes.
Converted and manufactured cannabinoids, including derivatives created through chemical synthesis or modification.
The scope of activities covered by this standard is extensive and includes:
The precise processing and careful handling of cannabinoid herbal materials, from raw plant matter to pre-extraction preparation.
All stages of extraction using various methodologies, subsequent refinement processes to purify and concentrate cannabinoids, and the final packaging of cannabinoid products to ensure stability and safety.
Note: For products specifically intended for use as dietary supplements, an additional addendum to the standard is required to address the unique regulatory and safety requirements pertinent to such applications.
1.4. CSQ Standard for Extraction Audit Requirements
CSQ Extraction audits are systematically structured into distinct modules, designed to ensure a thorough and comprehensive evaluation of operational compliance, ranging from foundational management systems to advanced quality controls:
Module 1: Requirements for All Licensed Operations
This foundational module covers general requirements for establishing a robust cannabis safety and quality system, demonstrating strong management commitment, ensuring strict regulatory compliance, maintaining thorough documentation and internal audits, implementing effective corrective actions and complaint management, and robust protocols for product recalls, product defense, fraud prevention, and crisis management.
Module 2A: Current Good Manufacturing Practices
Focuses on operational excellence in facility and maintenance, calibration and qualification of equipment, rigorous cleaning and sanitation protocols, responsible waste management (including cannabinoid and non-cannabinoid waste), integrated pest management, ensuring air and water safety, environmental monitoring, and controlled storage and distribution practices.
Module 3B: Requirements for Cannabinoid Products and Processes
Addresses the specifics of production and processing methodologies, detailed product requirements for various cannabinoid forms, and stringent quality control over all cannabinoid ingredients and processing inputs.
Module 4A: Hazard Analysis Critical Control Points (HACCP)
Encompasses the systematic development of a HACCP system, establishment of a competent HACCP team, detailed hazard analysis, identification of critical control points (CCPs), continuous monitoring procedures, documented corrective actions, system validation, and ongoing verification.
Module 5: Advanced Safety and Quality Management Systems
This module builds upon previous requirements by focusing on higher-level quality policies, regular management reviews, a commitment to continuous improvement, comprehensive risk management strategies, advanced validation and verification requirements, fostering a strong culture of safety, ensuring sustained customer satisfaction, and optimizing product realization processes.
1.5. CSQ Standard for Extraction Level System
The CSQ Certification Program offers three progressive levels of conformance, allowing operations to achieve certification tailored to their specific scope and complexity:
Level 1: CSQ Audit Requirements (Modules 1-2A)
This foundational level covers essential operational requirements, including general management systems and fundamental cGMPs. It is suitable for operations demonstrating basic compliance with safety and quality aspects.
Level 2: Level 1 + HACCP (Modules 1-4A)
Building upon Level 1, this level incorporates comprehensive Hazard Analysis Critical Control Points (HACCP) principles, making it suitable for operations that require advanced risk management for food safety or complex processing involving critical control points.
Level 3: Level 2 + Advanced Management Systems (Modules 1-5)
The highest level of certification, this includes Level 2 requirements along with advanced safety and quality management systems, focusing on continuous improvement, risk management, and a strong safety culture. This level is often required for operations seeking the most robust quality recognition and unannounced audits.
Operations are advised to contact a licensed Certification Body for an expert assessment to determine the appropriate certification level that aligns with their specific activities, products, and market requirements.
1.6. Audit Process and Duration
Scheduling: Audits are meticulously scheduled by a licensed Certification Body, approved by ASI Global Standards, and all audit details are accurately input into the central CSQ Database to ensure traceability and oversight.
Auditor Selection: The selection of auditors is a rigorous process undertaken by the licensed body, ensuring that chosen auditors possess the necessary qualifications, experience, and independence to comply fully with all CSQ standards and ethical guidelines.
Minimum Audit Duration: The duration of an onsite audit is dependent on the certification level and is designed to ensure adequate time for a thorough assessment:
Level 1: Requires a minimum of 1 day, covering Modules 1 through 3B. This includes general requirements and cGMPs.
Level 2: Requires a minimum of 1.5 days, extending to Modules 1 through 4A, which incorporates the HACCP system requirements.
Level 3: Requires a minimum of 2 days, encompassing all Modules (1 through 5), and is conducted as an unannounced audit, emphasizing continuous readiness and compliance.
Initial Audits: For initial certifications, a mandatory one-day offsite documentation evaluation is required prior to the onsite audit. This allows for a preliminary review of the applicant's quality management system documentation.
Scoring: Audit outcomes are determined following specific scoring rules and guidelines as detailed within the official CSQ Certification Program documentation, ensuring fairness and consistency in evaluations.
Corrective Actions: Any nonconformities identified during an audit must be diligently addressed and resolved by the audited operation within specified timelines and processes, as outlined in the CSQ program's corrective action procedures.
Certification: Successfully audited operations that demonstrate full compliance with CSQ standards are awarded a formal certificate. This certificate serves as an official testament to their commitment to safety and quality in cannabinoid substance production.
Part 2: Audit Requirements
Module 1: Requirements for All Licensed Operations
1.1. Cannabis Safety and Quality Management System – General Requirements
A comprehensive, documented cannabis safety and quality management system must be established and maintained, available in both electronic and hardcopy format for accessibility and record-keeping. This system is the cornerstone of an operation's commitment to compliance.
The system should explicitly outline:
All applicable audit requirements of the CSQ Certification Program, detailing how the operation intends to meet each standard.
Clear objectives to promote safety, quality, and complete regulatory compliance across all operations and products.
Identification of specific personnel and their roles and responsibilities in managing CSQ compliance, including a clear organizational chart.
Procedures ensuring that all relevant staff, especially those working in critical control areas, have immediate access to necessary documentation and understanding of applicable procedures.
It must contain detailed Standard Operating Procedures (SOPs), Prerequisite Programs (PRPs), various forms, logs, comprehensive training materials, and all supporting documentation necessary to demonstrate robust process control and quality assurance.
Integration of all applicable local, regional, and national regulations and documentation, ensuring that the system is fully compliant with all legal requirements in the operating jurisdiction.
Clearly defined parameters and guidelines for the appropriate and authorized use of the CSQ logo in promotional and marketing materials, preventing misuse.
Procedures for the regular maintenance and timely updates of the entire management system to reflect changes in regulations, processes, or best practices, ensuring its ongoing relevance and effectiveness.
1.2. Management Commitment
A formally documented policy must be in place, unequivocally expressing the top management's unwavering commitment to producing consistently safe, high-quality, and fully compliant cannabinoid products.
This policy must include specific, measurable objectives for safety and quality performance, such as reduction in complaints or successful audit scores, which are regularly tracked and reported.
The policy and its objectives must be effectively communicated to all staff members, from management to front-line workers, ensuring that everyone understands their role in achieving these goals.
Management is responsible for actively informing staff of relevant industry advancements, regulatory changes, and best practices through ongoing training and communication channels.
Management must ensure that all necessary resources, including trained personnel, appropriate equipment, and adequate funding, are consistently available to implement and maintain the CSQ safety and quality management system effectively.
The management policy and its effectiveness must undergo regular, documented review and monitoring by top management to identify areas for improvement and ensure its continued suitability and adequacy.
1.3. Regulatory Compliance
Documented procedures are essential for ensuring continuous compliance with all applicable local, state, federal, and international regulations pertaining to the cultivation, processing, manufacturing, and distribution of cannabinoid substances.
All operations must strictly follow all legal restrictions, including licensing requirements, allowable THC limits, packaging, labeling, and testing mandates specific to cannabinoid products.
All products manufactured or processed must meet or exceed applicable regulatory compliance standards for safety, purity, potency, and labeling claims, with documented evidence.
A robust system must ensure that all staff members, especially those involved in production, quality control, and distribution, are adequately trained and regularly updated on current and evolving regulations relevant to their job functions.
1.4. Documentation and Recordkeeping
Clear and consistent procedures for controlling and managing all program documentation are critical to maintaining an auditable and effective quality system. These procedures must include:
A master list of all controlled documents, clearly identifying their titles, unique identification numbers, and current version statuses to ensure only approved documents are in use.
Specific requirements for document identification, including unique numbering systems, clear titles, and diligent versioning/revision control to prevent the use of outdated information.
A defined authorization process for all changes to documents, requiring review and approval by designated personnel before implementation, with a clear audit trail of changes.
Methods to ensure the accessibility of current, relevant documents to all staff members who require them for their job functions, whether through electronic systems or physical copies in designated locations.
Protocols for record storage for a period that meets or exceeds all regulatory requirements and industry best practices, ensuring the availability of historical data for recalls, investigations, or audits.
A protocol must also be established to ensure the legibility, accuracy, and consistent format of all documented information, making records easy to understand and interpret for all stakeholders.
1.5. Internal Audits
Documented procedures for conducting annual internal audits are a cornerstone of continuous improvement, designed to systematically evaluate the effectiveness and conformity of the CSQ program within the operation.
These audits must meticulously cover all applicable requirements of the CSQ program, including management systems, cGMPs, HACCP, and advanced quality modules, to ensure holistic compliance.
Competent personnel, who are independent of the area being audited, must be clearly identified and trained for auditing tasks, possessing the necessary knowledge of CSQ standards and auditing techniques.
The results of internal audits, along with identified nonconformities and proposed corrective actions, must be formally communicated to relevant staff and management, fostering transparency and accountability.
A clear process must be in place to ensure that all identified nonconformities are thoroughly addressed, with root causes investigated, and effective corrective actions implemented and verified in a timely manner.
1.6. Corrective Actions and Preventive Actions (CAPA)
Robust procedures for documenting, evaluating, and implementing corrective actions (to address existing nonconformities) and preventive actions (to prevent potential nonconformities) are essential for quality system improvement. These must:
Ensure all documented deviations, nonconformities, and quality events are recorded legibly and clearly, providing sufficient detail for investigation and understanding.
Identify the root causes of nonconformities through systematic investigation and designate responsible personnel for initiating, implementing, and verifying corrective and preventive actions.
Include specific preventive measures to preclude recurrence of similar issues, alongside appropriate timelines for the complete investigation, implementation, and verification of resolutions.
Incorporate tracking and trending measures for ongoing review of CAPA effectiveness, allowing for analysis of recurring issues and overall system improvement.
1.7. Complaint Management
Detailed procedures for the efficient investigation and effective resolution of all product-related complaints are critical for maintaining customer trust and product quality. These procedures must:
Clearly identify responsible personnel or a dedicated department for the intake, logging, investigation, and resolution of each complaint, ensuring accountability.
Establish a systematic process to track and analyze complaints, including categorization by type, frequency, and severity, to identify trends and potential systemic issues.
Mandate that appropriate corrective actions are taken for all valid complaints to not only resolve the immediate issue but also, crucially, to prevent its recurrence across future production batches or services.
1.8. Product Recalls and Withdrawals
Comprehensive procedures for managing product recalls (for safety or regulatory reasons) and withdrawals (for commercial reasons) are paramount to public safety and regulatory compliance. These procedures must include:
Strict compliance with all regulatory requirements for conducting recalls, covering notification protocols, scope determination, product recovery, and public messaging.
Clearly identify personnel responsible for coordination and management of recall activities, including internal teams and external communication.
Develop effective communication plans with all involved parties, including regulatory authorities, distributors, retailers, and consumers, ensuring timely and accurate information dissemination.
Mandate that mock recalls are executed at least annually to test the effectiveness and efficiency of the recall procedure, identify weaknesses, and ensure personnel are proficient in their roles during a real event.
1.9. Product Defense
Procedures must be robustly designed to focus on defending against deliberate acts such as theft, intentional contamination, or malicious tampering of cannabinoid products and materials. These must:
Include regular threat assessments to identify potential vulnerabilities within the facility and supply chain, alongside detailed mitigation steps for establishing clear access control protocols for personnel and visitors.
Ensure that all cannabinoid materials, from raw ingredients to finished products, are secured in designated, access-controlled areas to prevent unauthorized access and diversion.
Provide mandatory training for all personnel in product defense protocols, including awareness of security risks, reporting procedures for suspicious activities, and adherence to access control measures.
1.10. Fraud Prevention
Procedures must proactively combat various forms of fraud, including economic adulteration, mislabeling, and substitution, to protect product integrity and consumer trust. These must typically include:
Regular vulnerability assessments specifically targeting risks of mislabeling, ingredient substitution, dilution, and contamination throughout the supply chain.
Implementing robust steps to verify label claims, including ingredient identity, potency, and origin, through documentation review, supplier audits, and product testing.
Mandatory annual reviews of these prevention procedures to assess their ongoing effectiveness, adapt to new fraud risks, and implement improvements based on evolving industry threats.
1.11. Crisis Management
Documented procedures for effectively responding to various crisis situations (e.g., natural disasters, major equipment failure, serious contamination events) are crucial for business continuity and safety. These must include:
Comprehensive lists of emergency contacts for key personnel (internal and external), first responders, regulatory agencies, and critical service providers, ensuring rapid communication.
Detailed plans for disaster response, including emergency evacuation procedures, secure product isolation, and mitigation strategies to minimize harm and damage.
Pre-defined communication strategies for internal and external stakeholders during crises, ensuring consistent, accurate, and timely information dissemination to employees, media, and regulatory bodies.
Module 2A: Requirements for Current Good Manufacturing Practices
2A.1. Facility and Facility Infrastructure
2A.1.1. Facility Construction and Design
Facilities where cannabinoid substances are processed must be purpose-built or suitably adapted for their intended use, ensuring that the design actively prevents cross-contamination between different process stages or products.
The design and construction must robustly include:
Regulatory compliant construction materials and methods that are durable, easy to clean, and resistant to degradation, meeting all applicable building codes and cannabis-specific regulations.
Adequate and appropriate lighting levels in all key operational areas, including processing, packaging, and quality control zones, to ensure visibility for tasks and inspection without creating glare.
Well-maintained infrastructure, including floors, walls, ceilings, and utilities, kept in a state of good repair to prevent accumulation of dirt, debris, or pests, and to minimize contamination risks.
Proper waste management systems, including designated collection points, appropriate drainage, and secure disposal routes, designed to prevent accumulation and cross-contamination from waste materials.
2A.1.2. Facility and Facility Infrastructure Maintenance
Facilities must be consistently maintained in a sanitary state to actively minimize contamination risks to products and processes. This requires proactive and reactive measures:
Regular and scheduled cleaning and stocking of facilities, including all processing rooms, storage areas, and common spaces, using approved cleaning agents and documented schedules.
Maintaining surrounding external areas free from debris, standing water, and pest harborage points, creating a clean perimeter to prevent ingress of contaminants or pests into the facility.
2A.2. Equipment, Maintenance, and Calibration
2A.2.1. Equipment
All equipment and utensils used in the processing, handling, or storage of cannabinoid substances must meet applicable regulatory requirements for design, construction, and materials, and must be unequivocally safe for their intended purposes, preventing product contamination or degradation.
2A.2.2. Maintenance
Documented procedures are required for how to effectively maintain all equipment and facility infrastructure, including detailed maintenance schedules (preventive and predictive) and records of all maintenance performed, parts replaced, and any repairs made.
2A.2.3. Calibration
Calibration procedures must be meticulously defined and thoroughly documented for all measuring and control equipment and utensils that impact product quality or safety (e.g., scales, thermometers, pressure gauges). This includes frequency, methods, acceptance criteria, and records of calibration.
2A.3. Cleaning and Sanitation
Detailed documented procedures outlining comprehensive cleaning and sanitation requirements must exist for all equipment, surfaces, and areas that come into contact with cannabinoid materials or could impact product quality. These procedures must granularly cover the types of cleaning materials and sanitizers to be used, their concentrations, application frequencies, and the clear identification of personnel responsibilities for each cleaning task.
2A.4. Waste Management
Robust procedures are required for the systematic handling of all waste generated within the facility, encompassing segregation methodologies, proper labeling of waste streams, and defined, compliant disposal methods to prevent contamination and ensure environmental responsibility.
2A.4.1. Cannabinoid Waste
Specific documented procedures for the secure collection, segregation, weighing, destruction, and disposal of all cannabinoid-containing waste materials, ensuring compliance with regulatory requirements for diversion prevention and environmental discharge.
2A.4.2. Non-Cannabinoid Waste
Documented procedures for the appropriate handling, segregation, labeling, and disposal of all non-cannabinoid waste streams (e.g., general trash, hazardous chemicals, packaging materials), emphasizing proper recycling when applicable.
2A.5. Integrated Pest Management
Documented procedures must be meticulously established for integrated pest control, including a systematic approach to pest risk assessments, implementation of preventive measures, regular monitoring for pest activity, and documented effectiveness checks of control strategies to prevent contamination and infestation.
2A.6. Facility Air Safety and Quality
Documented procedures ensuring appropriate air quality is maintained in all critical production areas, particularly those where exposed cannabinoid materials are handled. This includes controls for temperature, humidity, particulate matter, and airborne microbial contaminants, alongside validation of HVAC systems.
2A.7. Facility Water Safety and Quality
Procedures must be rigorously in place for water quality management, ensuring that all water used in operations—whether for processing, cleaning, or utilities—meets defined quality specifications and is suitable for its intended purpose, preventing contamination of products or surfaces.
2A.8. Environmental Monitoring
Procedures for systematically identifying and continuously monitoring environmental hazards, such as microbial contamination on surfaces or in the air, particularly in critical processing zones. This includes defining sampling locations, frequencies, test methods, alert and action limits, and corrective actions for deviations.
2A.9. Storage and Distribution
2A.9.1. Dry Goods Storage
Procedures for the proper storage of dry goods, including raw materials, packaging components, and finished products, under conditions (e.g., temperature, humidity) that prevent deterioration, cross-contamination, and pest infestation.
2A.9.2. Chemical Controls and Storage
Documented procedures for the safe handling, storage, labeling, and segregation of all chemicals (e.g., cleaning agents, solvents, laboratory reagents) to prevent contamination, ensure personnel safety, and comply with hazardous material regulations.
2A.9.3. Temperature and Atmosphere Controlled Storage
Procedures detailing the requirements for storage areas that necessitate specific temperature, humidity, or atmosphere controls (e.g., refrigeration, freezers, inert gas environments) for stability and quality of cannabinoid materials and products.
2A.9.4. Shipping and Receiving
Documented procedures governing the safe and secure receiving of incoming materials and shipping of outgoing products, ensuring proper identification, inspection, documentation, temperature control (if needed), and prevention of damage or contamination during transit.
2A.10. Inventory Management
2A.10.1. Identification and Traceability
Procedures for uniquely identifying and fully tracing all raw materials, in-process materials, and finished cannabinoid products from receipt through distribution, enabling quick recall if necessary and ensuring regulatory compliance.
2A.10.2. Acceptance and Release
Documented procedures for the acceptance, release, or rejection of all incoming materials and finished products based on predefined specifications and quality control testing, ensuring only compliant materials enter production or reach the market.
2A.10.3. Stock Management
Procedures for effective stock management, including methods for stock rotation (e.g., First-In, First-Out (FIFO) or First-Expi ry, First-Out (FEFO)), managing inventory levels to prevent obsolescence, and regular inventory reconciliation.
2A.10.4. Hold and Release (Quarantine)
Documented procedures for placing materials or products on 'hold' (quarantine) due to nonconformity or pending quality evaluation, and a clear process for their eventual release or rejection after investigation and disposition.
2A.11. Supplier Approval and Vendor Qualifications
Documented procedures for the rigorous approval and ongoing qualification of all suppliers and vendors of critical materials, components, and services (e.g., raw cannabis, solvents, packaging, testing labs), ensuring they meet specified quality, safety, and regulatory standards.
2A.12. Production and Process Controls
2A.12.1. Standard Operating Procedures
Detailed Standard Operating Procedures (SOPs) must be developed and strictly followed for all production and process steps, ensuring consistency, repeatability, and control over critical parameters that affect product quality and safety.
2A.12.2. Process Flow, Segregation, and Cross-Contamination Prevention
Procedures mapping out the logical process flow, implementing effective physical or procedural segregation between incompatible activities, and robust controls to actively prevent cross-contamination between different products, batches, or materials.
2A.12.3. Pre-Operational Inspections (Line Clearances)
Documented procedures for conducting thorough pre-operational inspections or "line clearances" before the start of any new production run or product changeover, verifying that equipment is clean, settings are correct, and all previous batch materials have been removed.
2A.12.4. Materials and Supplies
Procedures for the control of all materials and supplies used in production, from receipt and storage to dispensing and in-process handling, ensuring their correct identity, quality, and prevention of mix-ups or contamination.
2A.12.5. Rework
Documented procedures specifically addressing how any reworked or reprocessed cannabinoid material or product is handled, including clear criteria for rework, processing methods, quality testing, and documentation to ensure it meets original specifications and regulatory requirements.
2A.12.6. Cross-Contamination Controls
Comprehensive procedures and physical controls (e.g., dedicated equipment, segregated areas, airlocks, personnel flow) specifically implemented to prevent cross-contamination between different cannabinoid products, allergen-containing products, or materials with varying potencies.
2A.12.7. Allergen Management
Documented procedures for identifying, segregating, and controlling allergens if they are present in any ingredients or finished products. This includes preventing cross-contact, clear labeling, and personnel training on allergen awareness, especially for dietary supplements.
2A.12.8. Product Labeling and Packaging
Procedures for ensuring all product labeling is accurate, compliant with regulatory requirements (e.g., potency, ingredients, warnings), and securely affixed. Packaging must be suitable to protect the product's integrity, prevent tampering, and maintain quality throughout its shelf life.
2A.12.9. Product Sampling and Testing
Documented procedures for the systematic sampling and comprehensive testing of raw materials, in-process materials, and finished cannabinoid products. This includes defining sampling plans, test methods, acceptance criteria, and the use of accredited laboratories to verify purity, potency, and safety (e.g., for pesticides, heavy metals, microbial contaminants).
2A.13. Personnel Requirements
2A.13.1. Personnel Roles and Responsibilities
Clearly documented roles, responsibilities, and authority for all personnel involved in activities impacting product safety and quality, including a hierarchical structure to ensure accountability and clear lines of communication.
2A.13.2. Personnel Training
Comprehensive training programs and documented records for all personnel, covering their specific job functions, GMPs, hygienic practices, relevant SOPs, safety protocols, and awareness of the CSQ program, with regular refresher training.
2A.13.3. Personnel Health (Illness and Injuries)
Procedures for managing personnel health, including policies for reporting illness or injuries, restrictions for working in production areas when ill, and protocols to prevent health issues from compromising product safety.
2A.13.4. Personnel Hygiene and Cleanliness
Strict procedures for personnel hygiene, including requirements for handwashing frequency and technique, maintaining personal cleanliness, and ensuring that personnel do not pose a risk of contamination to products or surfaces.
2A.13.5. Personnel Clothing, Jewelry, and Personal Belongings
Procedures specifying appropriate clean and protective clothing (e.g., uniforms, lab coats) for production areas, restrictions on wearing jewelry, and policies for storing personal belongings to prevent contamination risks.
2A.13.6. Personnel Protective Equipment (PPE)
Documented procedures for the selection, proper use, maintenance, and storage of appropriate Personal Protective Equipment (PPE) for personnel, ensuring their safety and the prevention of product contamination during various tasks.
2A.13.7. Handwashing
Specific and detailed procedures for effective handwashing, including requirements for handwashing stations, appropriate soaps and sanitizers, and mandatory handwashing frequencies, especially before entering production zones, after breaks, and after handling non-product materials.
2A.13.8. Authorized Contractors, Service Providers, and Visitors
Procedures for controlling the access and conduct of authorized contractors, service providers, and visitors within the facility, ensuring they adhere to all relevant safety, hygiene, and product defense protocols and receive appropriate briefings or supervision.
Module 3B: Requirements for Cannabinoid Products and Processes
3B.1. Requirements for the Production and Processing of Cannabinoid Materials and Products
3B.1.1. Extraction and Refinement Activities
Detailed procedures and controls for all extraction and refinement activities, encompassing various methodologies to produce cannabinoid concentrates, isolates, and distillates, ensuring efficiency, safety, and product quality.
3B.1.2. Solvent-Based Extraction and Refinement
Specific procedures for solvent-based extraction methods (e.g., ethanol, hydrocarbons, CO_2), including controls for solvent quality, recovery efficiency, residual solvent limits, and safety precautions for handling flammable or pressurized gases.
3B.1.3. Solvent-Free Extraction and Refinement
Specific procedures for solvent-free extraction and refinement methods (e.g., rosin press, ice water hash), ensuring process parameters (temperature, pressure) are controlled to yield quality products without chemical residues.
3B.1.4. Extraction Inputs and Controls
Procedures for controlling all inputs into the extraction process, including raw cannabis material (e.g., flower, trim), solvents, and other processing aids, ensuring their quality, identity, and suitability for the intended product.
3B.1.5. Air, Carbon Dioxide, Liquefied Petroleum Gases (LPG), and Other Process Gases
Procedures for verifying the quality and purity of all gases used in processing (e.g., compressed air, CO_2, propane, butane, nitrogen), ensuring they meet purity specifications and are free from contaminants that could affect the product.
3B.1.6. Ethanol and Other Liquid Organic Solvents
Procedures for the procurement, storage, handling, recovery, and reuse (if applicable) of ethanol and other liquid organic solvents, including safety data sheets, flammability controls, and purity testing for residues.
3B.1.7. Water Used During Extraction and Refinement
Procedures for ensuring the quality of all water used during extraction and refinement activities meets appropriate levels (e.g., potable, purified, WFI) and is regularly monitored for microbial and chemical purity.
3B.1.8. Water Ice and Dry Ice Safety and Quality
Procedures for the safe handling, storage, and quality verification of water ice and dry ice used in processing, ensuring they are free from contaminants and used in a manner that protects product quality and personnel safety.
3B.1.9. Other Solid and Liquid Processing Inputs
Procedures for controlling the quality, identity, and specification of all other solid and liquid processing inputs (e.g., filter aids, adsorbents), ensuring they are food/pharmaceutical grade where appropriate and do not introduce contaminants.
3B.1.10. Non-Cannabinoid Ingredients Used During Manufacturing
Procedures for the sourcing, acceptance, storage, and use of all non-cannabinoid ingredients (e.g., carrier oils, flavors, terpenes) incorporated into formulated products, ensuring their quality, safety, and compliance with all relevant food/dietary supplement regulations.
3B.1.11. Indoor Air Quality, Airflow, and Environmental Conditions
Procedures for monitoring and controlling indoor air quality, airflow patterns (to prevent cross-contamination), and other environmental conditions (e.g., temperature, humidity) in processing areas critical for product quality and stability.
3B.1.12. Blending, Compounding, Formulation, and Mixing
Detailed procedures for blending, compounding, formulation, and mixing operations, ensuring homogeneity, accurate dosing, and prevention of contamination or degradation during these crucial steps.
3B.2. Requirements for Cannabinoid Materials and Products
3B.2.1. Cannabinoid Herbal Materials
Specific requirements for the sourcing, acceptance, storage, and preparation of raw cannabinoid herbal materials (e.g., cannabis flower, trim) ensuring they meet defined quality parameters, purity specifications, and regulatory compliance before extraction.
3B.2.2. Cannabinoid Substance Products
Specific requirements for intermediate and bulk cannabinoid substance products (e.g., crude extract, distillate, isolate) including potency specifications, purity profiles (e.g., residual solvents, pesticides, heavy metals, microbial), and stability criteria.
3B.2.3. Formulated Cannabinoid Substance Products
Specific requirements for finished formulated cannabinoid substance products (e.g., tinctures, edibles, vapes) including final potency, homogeneity, specific ingredient declarations, shelf-life studies, packaging integrity, and final product testing to ensure consumer safety and compliance.
Module 4A: Requirements for Hazard Analysis Critical Control Points
4A.1. HACCP System
Procedures for establishing, implementing, and maintaining a robust Hazard Analysis Critical Control Point (HACCP) system following the seven principles of HACCP, designed to identify, evaluate, and control food safety hazards.
4A.2. HACCP Team
Procedures for forming a multidisciplinary HACCP team with defined roles, responsibilities, and appropriate expertise (e.g., processing, engineering, quality assurance) to develop and manage the HACCP plan effectively.
4A.3. Product Descriptions & Intended Use
Procedures for creating detailed descriptions of all cannabinoid products, including ingredients, processing methods, packaging, and specific intended use by the consumer, which informs the hazard analysis.
4A.4. Flow Diagram
Procedures for developing accurate and verified flow diagrams for each product or product category, illustrating every step in the process from raw material receipt to final distribution, crucial for hazard identification.
4A.5. Hazard Analysis
Procedures for conducting a thorough hazard analysis to identify all potential biological, chemical, and physical hazards reasonably likely to occur at each step, and evaluating their significance and likelihood of occurrence.
4A.6. Critical Control Points
Procedures for determining Critical Control Points (CCPs) within the process where control can be applied and is essential to prevent or eliminate a food safety hazard or reduce it to an acceptable level.
4A.7. Critical Limits
Procedures for establishing precise critical limits for each CCP, which are measurable parameters that separate acceptable from unacceptable conditions, ensuring the controlled process remains safe.
4A.8. Monitoring
Procedures for establishing a monitoring system for each CCP, including defined methods, frequencies, and responsible personnel to conduct observations or measurements to assess if the CCP is under control.
4A.9. Corrective Actions
Procedures for defining corrective actions to be taken when monitoring indicates a deviation from a critical limit at a CCP, including actions to bring the process back into control and handle affected product.
4A.10. HACCP System Validation
Procedures for conducting initial and periodic validation of the HACCP plan, providing scientific and technical evidence that all elements of the HACCP plan are effective in controlling the identified hazards.
4A.11. HACCP System Verification
Procedures for establishing verification activities (e.g., audits, calibration checks, records review) to ensure the HACCP system is operating according to the plan and is effectively controlling hazards.
Module 5: Advanced Cannabis Safety and Quality Management Systems
5.1. Cannabis Safety and Quality Management System
Procedures for the continuous enhancement and strategic management of the overall cannabis safety and quality management system, integrating advanced concepts beyond basic compliance to drive excellence.
5.2. Safety and Quality Culture
Procedures designed to foster and embed a proactive culture of safety and quality throughout the organization, involving all employees in adopting shared values, behaviors, and beliefs regarding product integrity and consumer protection.
5.3. Customer Satisfaction
Procedures for systematically monitoring, measuring, and actively improving customer satisfaction, including gathering feedback, analyzing complaint data, and implementing improvements based on customer input.
5.4. Product Realization
Procedures for managing the entire product realization process, from product conception and design through development, production, delivery, and post-delivery activities, ensuring that customer and regulatory requirements are consistently met at every stage.
Part 3: Appendices
3.1. Applicable Cannabinoid Materials and Products
This appendix explicitly specifies all categories of cannabinoid materials and finished products that are covered under the CSQ Standard for Extraction. This includes, but is not limited to, products meant for various consumption methods such as inhalation (e.g., vape cartridges, dabs), ingestion (e.g., edibles, tinctures, capsules), and topical use (e.g., balms, creams, lotions), detailing the specific requirements for each type.
3.2. Reference Documents
This section comprehensively outlines all external regulatory references and industry standards that were utilized in the compilation and development of this document. It includes, for example, specific sections from the Code of Federal Regulations (CFR) relevant to food, drug, or cosmetic manufacturing, various ASTM standards pertinent to cannabis testing or processing equipment, and other authoritative guidelines that lend scientific and regulatory weight to the CSQ standard.
3.3. Terminology Related to the CSQ Certification Program
This critical appendix provides clear and concise definitions for all key terms and phrases specifically utilized within the CSQ Certification Program documents. This includes, but is not limited to, definitions for 'hemp,' 'marijuana,' various 'cannabinoid products,' and distinctions for product classifications such as 'dietary supplements' and 'inhalables,' ensuring consistent understanding and interpretation across all stakeholders.