“Validation” describes a careful method/process to ensure that a system, process or equipment is performing accurately and within expectations.
As the cannabis industry is starting to adopt industrial equipment, software and machinery, there is a growing need for validation consulting to prove concepts and methods. Equipment validation, for example, is strongly encouraged to ensure the equipment is properly producing the desired result – e.g., if a cannabis extraction machine is designed to produce 5 mL of oil after X and Y processes are performed, the equipment should be validated to ensure it is actually producing 5 mL of oil. This is an over-simplification of validation, but it communicates the general concept.
A properly designed system will provide a high degree of assurance that every step, process, or change has been properly evaluated before its implementation. For example, random selection of a finished product within a batch is a final check but does not ensure that the products within that batch are consistent and expected. The idea is that an employed method or piece of equipment should deliver consistency across multiple uses.
In industries such as pharmaceutical drug manufacturing, the risk of contamination (or over-potency of key pharmaceutical ingredients) poses a very serious threat to the end consumer’s health, and opens the door for legal liability on the manufacturer. In industries which have lower consequences around inconsistencies (e.g., doll manufacturing) validation may not be a worthwhile endeavour at every stage in the process. However, because cannabis is often smoked or vaporized, as well as cannabis being used by very sick individuals, the risk of contamination or incorrect dosing is significant to both the end consumer and the producer.
The validation subsections in a manufacturing facility can be as extensive as; equipment validation, facilities validation, cleaning validation, process validation, analytical method validation, software validation, packaging validation and cold chain validation, among others.
The Cannabis Compliance Inc. validation team has helped customers by adopting a risk-based approach throughout the lifecycle of the quality system considering patient safety, data integrity and product quality. The above approach will also support clients on regulatory compliance and the confidence that their overall quality system in place are validated. Any cannabis producer using sophisticated equipment or production methods should be instilling validation practices within their business.
Contact us to today to start a conversation around our validation consulting services. Cannabis Compliance has over 60 full time salary employees, many from industries where validation work is routine, such as pharmaceutical.