5 Things US Cannabis Operators Need to Know About GACP & GMP
Setting the Standard
Good Manufacturing Practices (GMP) are vital quality assurance standards ensuring product consistency and safety across industries. They prevent errors, safeguard worker health, and protect the public. GMP is essential in pharmaceuticals, food, cosmetics, and more. This blog explores GMP principles, the absence of GMP guidelines in the US cannabis industry, and how businesses can prepare for future regulatory changes. We’ll also discuss GMP’s influence on architectural design and introduce Good Agricultural and Collection Practices (GACP) for medicinal plants, emphasizing GMP’s continuous pursuit of manufacturing excellence.
1. What is GMP?
GMP, or Good Manufacturing Practices, is the quality assurance process in product production that ensures product consistency and quality. GMP guidelines and compliance are critical for quality assurance, worker safety, and protecting human health. GMP prevents errors and inconsistencies that cannot be eliminated through quality control of the finished products and consumer goods. With GMP, it is possible to be sure that every unit of medicine or consumer goods manufactured is of the same quality as the units of medicine tested in the laboratory.
Key Principles of GMP:
- Creation and enforcement of Standard Operating Procedures (SOPs).
- Comprehensive documentation of all procedures and processes.
- Validation of SOP effectiveness.
- Development and implementation of efficient working systems.
- Development of employee competencies.
- Regular maintenance of systems, equipment, and facilities.
- Prioritizing cleanliness to prevent contamination.
- Ensuring quality is central to the design, development, and manufacturing workflow.
2. Why are there currently no GMP guidelines for cannabis in the United States?
In the United States, the Food and Drug Administration (FDA) recommends guidelines for anything food, cosmetics, drug, or pharmaceutical-related. These guidelines consist of processes, procedures, and documentation that ensure manufacturing consumer goods are consistently produced and controlled according to set quality standards. Unfortunately, as the federal law currently states, the use, sale, and possession of cannabis containing over 0.3% THC by dry weight remains illegal as a Schedule I drug type under the federal Controlled Substance Act of 1970, despite laws in the majority of states that have enacted legislation permitting exemptions for various uses, including medical, industrial and recreational use.
Because cannabis is currently a Schedule I drug type (sadly, the same category as Heroin and MDMA), federal agencies, such as the FDA, have not developed GMP guidelines for licensed and compliant cannabis operators. As a result, state lawmakers and cannabis business owners are forced to navigate this new and rapidly evolving industry without any standardized guidelines.
On August 29, 2023, the Department of Health and Human Services (HHS) recommended rescheduling marijuana from Schedule I to Schedule III under the Controlled Substances Act (CSA) to the Drug Enforcement Administration (DEA). However, in the near term, this recommendation is unlikely to significantly impact the cannabis industry because the Drug Enforcement Agency must now conduct its review and decide whether to follow the HHS recommendation. It also does not legalize cannabis. State-licensed cannabis businesses will still be operating in violation of federal law. However, in the long term, the FDA could provide specific guidelines or subject cannabis to existing regulatory authority.
3. What can cannabis business owners do to be
GMP-ready as legislation changes in the future?
Cannabis operators can get critical insights into what GMP guidelines may potentially look like in the future for the US from global cannabis companies that are certified EU-GMP. Some of the differences between EU-GMP and US-GMP are that the EU-GMPs require manufacturers to have a pharmaceutical quality system (PQS), encompassing a broad range of quality management activities. The US-GMPs emphasize the establishment of a quality control unit (QCU) and use quality systems but do not have a specific requirement for a PQS.
Basic Requirements of EU-GMP:
- All manufacturing processes are clearly defined, systematically reviewed in the light of experience, and shown to be capable of consistently manufacturing medicinal products of the required quality and complying with their specifications.
- All critical steps of manufacturing processes and significant changes to the process are validated.
- Appropriately qualified and trained personnel.
- Adequate premises and space.
- Suitable equipment and services.
- Correct materials, containers, and labels.
- They approved procedures and instructions by the Pharmaceutical Quality System.
- Suitable storage and transport.
- Written instructions and procedures in unambiguous language tailored to the provided facilities.
- Operators undergo training to ensure the correct execution of procedures.
- During manufacture, operators create records manually or use recording instruments to demonstrate that they followed all steps required by the defined procedures and instructions, ensuring the expected quantity and quality of the product.
- Any significant deviations are fully recorded and investigated to determine the root cause and appropriate corrective and preventive action implemented.
- Manufacturers retain production and distribution records in an understandable and accessible form, enabling the tracing of the batch’s complete history.
- The distribution of the products minimizes any risk to their quality and takes account of Good Distribution Practices.
- A system is available to recall any product batch from sale or supply.
- The team examines product complaints, investigates the causes of quality defects, and takes appropriate measures to prevent the recurrence of defective products.
4. How does GMP impact architectural design?
GMP can significantly influence the layout of a cultivation, extraction, and manufacturing facility and the selection of construction materials and equipment. The industrial architect must design the facility per the GMP regulations when applicable. Facility design for a GMP-compliant warehouse includes having designated areas for raw materials, finished goods, quarantine products, rejected products, etc. The warehouse must be dry, clean, and well-lit. The storage conditions shall be as per the material requirements.
Features to Incorporate in Facility Design:
- Design and construct the facility to ensure hygienic production conditions.
- Building materials, when applicable, should be easy to clean and sanitize.
- There should be no way for the entry of insects, pests, birds, vermin, and rodents.
- The facility should be spacious.
- The facility has to be at a location where there are no fumes. The design should prevent any fumes or infestation of the product.
- There should be covering on walls and floors, and surfaces should have cleanable surfaces.
- The facility area should be free of cracks and open joints to avoid dust collection.
- There should be segregation between departments and, in some cases, bio-secure vestibules for changing out personal protective equipment (PPE).
- The facility infrastructure design should have a dedicated HVAC system based on area classification.
- The facility should have a flexible layout.
- The design must provide well-lit, ventilated production areas with air control facilities.
- Design the drainage and plumbing system to prevent backflow and ensure adequate sizing.
- Avoid open drains.
- The construction process should not cause any negative impact on the environment.
- The facility should have a provision for secure, hazardous, and inflammable materials as per the regulations.
- Design a proper fire protection system.
- Piping, electrical fittings, and other utilities should not create a recess.
- Provide coloring and direction of flow on service lines.
5. What is GACP?
The World Health Organization (WHO) developed GACP, or Good Agricultural and Collection Practices for medicinal plants, in 2003 to enhance the safety, efficacy, and sustainability of medicinal plant material used in herbal medicines in the market. Specific to the cannabis industry, GACP consists of the practices used during agricultural production, which includes processes and procedures in the following stages: Tissue Culture, Mother/Stock, Propagation, Vegetative, Flowering, and Harvesting. Typically, the drying stage and all manufacturing after drying is where the transition happens from GACP to GMP.
Main Objectives of GACP Guidelines:
- To contribute to the quality assurance of medicinal plant materials used as the source for herbal medicines to improve finished herbal products’ quality, safety, and efficacy.
- To guide the formulation of national and regional GACP guidelines and GACP monographs for medicinal plants and related standard operating procedures.
- To encourage and support the sustainable cultivation and collection of medicinal plants of good quality in ways that respect and support the conservation of medicinal plants and the environment in general.
GMP compliance is a continuous journey, not a destination. Regular audits, swift identification of potential deviations, and corrective actions are all part of this process. Embracing a culture of continuous improvement and having a team that understands and implements the principles and components of GMP are the first steps towards ensuring ‘Good’ Manufacturing Practices become ‘Great’ Manufacturing Practices.