October 15, 2020
Cannabis is listed in Schedule I under the Controlled Substances Act (CSA) at the federal level in the USA. Several states have legalized cannabis for medicinal and recreational purposes and have mandated specific testing regimes for cannabis products to ensure public safety and product efficacy. Some of these regimes include potency testing, screening for contaminants, such as pesticides, microorganisms. Current cannabis regulations protect public health by emphasizing on quality testing of products. The regulations for cannabis testing vary from one state to another. The ever-changing regulations pose challenges for start-up cannabis testing laboratories and existing laboratories interested in entering into the cannabis testing industry. Good Manufacturing Practice (GMP) is a set of best practices that guide the cannabis industry to produce safe products for consumption, right from seed to sale.
GMP is a system that ensures products are consistently produced as per quality standards specified. GMP is a part of Quality Assurance (QA) and helps to minimize the risks involved in various stages of the production and manufacturing process. It is a myth that GMP covers only the manufacturing process. GMP covers the production process as well. GMP is also referred to as CGMP (Current Good Manufacturing Practice) to emphasize the importance of using the latest technologies and systems to comply with the GMP regulations.
GMP applies to all areas of the cannabis industry, including cultivation, extraction, analytical testing, storage, product labeling, retail sales or dispensary. Some of the aspects of the production process GMP covers include materials, premises, analytical instruments, storage, personnel training, record maintenance, hygiene maintenance, complaint handling, and product development. GMP requires strict monitoring of the production process, right from cultivation, testing, to packaging and distribution.
A GMP certification enables cannabis testing laboratories to prove their competency in generating accurate, valid, and reliable test results. GMP requirements for cannabis testing facilities include strictly implementing quality control processes, assigning analytical tasks to skilled laboratory staff, using high-quality instruments for analytical testing, implementing a procedure to effectively handle complaints. GMP certification may not be mandatory in the United States, however, some countries require testing facilities to meet GMP requirements before they can provide commercial services to customers. Guide-104 GMP is essential for medical cannabis companies in Canada. The European Union’s GMP (EU-GMP) is considered as a gold standard in the cannabis industry. EU GMP certification is mandatory for cannabis companies interested to export medical cannabis products to EU (European Union) countries. Some European countries, such as Germany, have legalized medical and scientific use of cannabis. Some other countries, such as Denmark and Portugal, are on the path of legalizing cannabis for medicinal use.
Some good documentation practices of GMP are adopted from the United States Pharmacopeia General Chapter <1029>. Some good documentation practices include maintaining clear, concise, and legible records, recording data entries when activities are performed, and implementing a documentation system to ensure data integrity and quick retrieval of current and archived records and data.
By securing a GMP certification, cannabis testing laboratories can demonstrate that their operations match the international laboratory operating standards. Some additional benefits of having a GMP certification are as follows:
GMP certification is becoming increasingly important for cannabis testing and extraction facilities to meet international standards and to remain competitive. The first step is to do a gap analysis to determine the operational changes needed to meet the requirements of the standard. It is important to estimate the cost and time required to bridge the operational gap to achieve GMP certification.
Cannabis testing laboratories should define their management structure and should clearly define the responsibility, authority, and interrelationship of all laboratory staff involved in analytical activities whose work may influence the test results. Cannabis testing facilities must maintain detailed, accurate, and up-to-date records of all standard operating procedures (SOPs) followed in the laboratory. Laboratories must document all test methods being used to analyze cannabis samples and must validate them before use. Testing areas must be clean and temperature and humidity-controlled. Processes must be verifiable and repeatable, and any process deviations should be recorded. Cannabis testing laboratories must identify and implement missing programs if any. For example, a laboratory is maintaining proper documentation of all laboratory activities, however, does not have a stability program to determine the shelf-life of a product. Due to the missing stability program, the laboratory is unable to determine the expiration date of the product once it leaves the testing facility. Hence, testing facilities must determine the missing programs and implement them ahead of a GMP audit.
To maximize the chances of passing the official GMP inspection, testing facilities can undergo a mock audit by a third-party auditor who is aware of the official inspection process and has an in-depth understanding of the GMP requirements. It helps laboratories to fill the operational gaps and to face official GMP inspectors with confidence.
Complying with various GMP requirements and getting GMP certified is a challenging and time-consuming process, especially for those who are setting up a cannabis testing laboratory. Having a LIMS System in place can help laboratories to prepare for GMP audits.
A Cannabis LIMS helps manage and track all internal and external documents, ensure their periodic review, and exercise version control. It helps in assigning role-based access to authorized personnel to provide different access levels to the staff. It maintains records of analysts along with their job descriptions, training schedules, and competency records. A LIMS also records calibration and maintenance data and alerts laboratory managers if an instrument is outdated or unfit for analytical testing. A Cannabis LIMS can also be integrated with analytical instruments for automatic bi-directional data transfer, ensuring data integrity. A LIMS helps in maintaining an automatic Chain-of-Custody to regulate the transfer of samples from one technician to another. A Cannabis LIMS helps to maintain quality control test results as a part of GMP compliance. Furthermore, it also helps in maintaining a read-only audit trail to keep track of all laboratory activities along with a date and time stamp that is useful for audits.
GMP certification is essential for cannabis businesses interested in selling products across borders and for cannabis testing and extraction facilities interested in standardizing their operations. GMP certification assures the quality of test results generated by cannabis testing laboratories. GMPs enable testing facilities to continuously improve processes through the implementation of necessary controls by leveraging modern technologies and innovative approaches.
A LIMS is an important tool for cannabis testing laboratories aiming for GMP certification. A LIMS replaces inefficient and error-prone manual processes with automated processes to meet the various requirements of GMP and streamlines the quality assurance process. A LIMS helps track deviations from standard operating procedures. It helps to securely maintain laboratory documents and records training and competency of laboratory staff. Furthermore, LIMS brings in standardization, efficiency and helps testing laboratories to achieve GMP accreditation.
While GMP certification is useful yet optional for any cannabis testing labs, many are obtaining official accreditation in order to operate across state borders and internationally. Of the states that require accreditation, many specifically require cannabis testing facilities to attain ISO/IEC 17025 accreditation. For more information on ISO/IEC 17025 accreditation, please visit the following resources.