What is GxP?

Welcome another edition of Technical Tuesday! This week we are going to answer an important question, “What is GxP?”.

EVORA Cannabis Good Manufacturing Practices

Good Practice, or GxP, are a group of guidelines that pertain to a particular field within a regulated industry. Some common fields would be agriculture (GAP, or GAcP), documentation (GDocP), laboratory (GLP), manufacturing (GMP), and production (GPP). While they’re all different in their own right, their collective goal is to ensure that businesses who operate in regulated industries can consistently manufacture products that meet strict quality standards throughout the entire production lifecycle and are ultimately safe to use.

It is important to understand these guidelines and align them with your Quality Management System. Depending on what your target market and product plan will be, you may or may not require compliance to a particular guideline. A good example of this is if you’re going to be a processor in Canada, but you’re targeting the European market for sales, you’ll need to take EU-GMP Guidelines into consideration when you’re planning everything from your facility design to your SOP documentation and records. Perhaps you are a micro-cultivator looking to sell bulk flowers, being GAcP compliant increases the value of your product and opens the door to a wider range of purchasers.

If you are licensed in Canada, at minimum you will have to demonstrate how you meet GPP or Good Production Practices. Health Canada have put together a great document (https://www.canada.ca/en/health-canada/services/cannabis-regulations-licensed-producers/good-production-practices-guide.html) that outlines how to meet the requirements of Part 5: Good Production Practices (GPP) of the regulations. If you are new to the game and not sure where to begin, Good Production Practices are a great first step in understanding what always need to be considered when establishing your business processes.

Cannabis Good Agricultural Practice

Having a strong Quality Management System that meets or exceeds the various relevant GxP guidelines to your business strategy is crucial in establishing product consistency and standardization. They will help focus your business, provide a platform for evidence-based decision making and pave the way for continuous improvement.

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Batch Records; Tool or Torture?

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Good Data In, Good Data Out