Hazard Analysis and Critical Control Points.
Hazard Analysis and Critical Control Point (HACCP) program have scientifically established critical limits. The Codex Alimentarius as well as the National Advisor Committee on Microbiological Criteria of Food both recognize that this systematic approach to food safety consists of three aspects: identification, evaluation, and control. The aim of an effective HACCP program is to identify points within a process that are essential to producing a safe, high quality product.
Closely monitoring CCPs will ensure that tough decisions about recalls never happen or happens on minimal occasion. Recalls may occur due to product adulteration or a product being improperly formulated and therefore, still adulterated. Recall associated risks are mitigated purposefully and methodically when a process has designated points where data is collected and recorded which indicates that action needs to be taken to avoid adulterating a product. An effective HACCP program is especially critical for high throughput or continuous production lines, batch production lines with high risk for improper compounding or formulation, and batch processes producing end products that are easy to contaminate. It is interesting to note that the international standard for Food Safety Management System, known as ISO 22000, combines HACCP and ISO 9001:2000 along with pre-requisite programs that GMPs, QMS, and other related programs into a thorough and comprehensive management system. This addresses facilities from farm to fork.
In 2011, President Obama signed into effect the Food Safety and Modernization Act. This new legislation shifted the focus of food safety from a responsive one to a preventative and risk-based approach. FSMA mandated the development of HACCP programs for food producers, beverage producers, farms, and holding points for agricultural goods. The primary aim is to prevent food-borne illness. A second aim is to protect the food supply from both intentional and unintentional bioterrorism.
Why do I need a Cannabis HACCP program?
Identifying CCPs, establishing critical limits for CCPs, monitoring CCPs, and record keeping is valuable because it provides additional details about each batch that is produced. Holding critical control points within a designated range contributes to consistency of product quality. Scaling up an operation and maintaining product quality and compliance is difficult if processes are not standard and validated with state or federal guidelines intentionally addressed within SOPs and GMPs. Compiling the recorded data from monitoring CCPs and other critical steps within an SOP into a batch record will prove that quality between batches remains the same.
Developing a strong, thorough, and customized Cannabis HACCP program provides control over a production line, this control is fed by insight into the process on a mostly continuous basis. Cannabis HACCP programs also establish corrective actions to follow prior to instances where CCPs fall out of their established critical limits. Having corrective actions already established makes production much smoother, minor issues that can potentially become halts in production flow or decrease end product quality, cease to be large headaches costing hours upon hours of meeting time and back and forth conversations concerning what to do. Instead, correcting a CCP becomes yet another procedure that is already established and the staff can be trained to handle in a semi-autonomous manner.
Water Activity in Cannabis.
Water activity is the ratio of water vapor pressure in matrix over the vapor pressure of pure water at the same temperature.
It is a measure of the “free water” within a matrix. Cannabis flowers should be dried to a water activity level less than Aw=.65, if it is not, spoilage microbes can grow on flowers during the cure and give them an undesirable look and smell. It can possibly even make patients sick and probably will not pass visual inspection by a regulated cannabis lab.
Water Activity’s Critical Limit is AW=.65.
“When we get our flower from harvest, we have to think about the drying and curing process, where mold and bacteria can spoil our harvest,” said Dr. Markus Roggen, Co-Chair of the Scientific Advisory Committee of NCIA and Vice President of Extraction at OutCo. It has been scientifically proven that decreasing water activity inhibits spoilage microbe growth. Therefore, water activity should have a value based critical limit that is monitored and logged at multiple points between the initial harvest, the dry process, curing/aging and packaging for distribution. The critical limit for drying Cannabis flowers is Aw of .65. An internal standard may be less than this value. This limit, again, was established to stop growth of bacteria and mold on Cannabis, especially flowers that are intended for combustion. Control of any critical control point must be considered when engineering a manufacturing process, especially a critical control point that can easily fluctuate and that is entirely dependent upon environmental factors. Read about the Cannabis HACCP implementation for monitoring water activity that Dr. Roggen completed here.
Mycotoxin Production within Cannabis Batches with Aw>.65.
Too much free water within the cannabis matrix can also allow for metabolizing of secondary metabolites from mold and fungi that may germinate in an environment above Aw=.65. These metabolites include types of mycotoxin that are not allowed to be present within cannabis matrix intended for any retail or sometimes even further refinement. Extraction optimization experimentation may reveal an optimal moisture content range, nevertheless, flower water activity should still fall below Aw=.65 if it is going to be stored. Mycotoxins have been detected within cannabis extract, therefore, flowers with confirmed presence of Aspergillus mycotoxin producing species and testing positive for mycotoxin may not be allowed to be processed into extract and depending on the amount cannot go to market. Monitoring water activity can help prevent this from occurring.
There are many variables that contribute to variance of product quality within batches of that product. Identifying critical control points will ensure, at minimum, anything that can be hazardous to human health is monitored and there is assurance that no adulterating or contaminating substances are present. Limits are established based on solid scientific research often funded by regulating bodies and completed by universities and public health agencies. The limits should be monitored, and a system established for supervising large scale production environments.
Orion GMP Solutions is a Pharmaceutical Engineering Firm based out of Denver Colorado. We specialize in the implementation and auditing cGMPs for GMP Cannabis Manufacturers. If you would like to get more information, please send us an email at [email protected]
This content was written and sponsored by Orion GMP Solutions.