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Now that your GMP facility has been opened, it’s time to add some new products to your new facility. Luckily, your facility is already GMP-certified, so adding new products is much easier than when you were initially qualifying the facility. Whether it be adding or repurposing rooms, ordering new equipment and procedures, the process will be smoother with certification.
Your journey maneuvering through the start-up phase of Good Manufacturing Practices (GMP) will finish with certification of your building, processes and ramping up your manufacturing. Finally. All of the preparation and work that went into selecting, designing & building your facility, including choosing & installing your equipment, setting up your laboratory, Enterprise Resource Planning (ERP), making your Quality Assurance Plans and staffing your facility will be tested by regulators before you can start operations.
No matter what you build or which equipment you purchase, your business cannot be successful without hiring key staff positions and employing knowledgeable personnel. As discussed in the previous installment, almost every step in the Good Manufacturing Practices (GMP) process requires the input and approvals of competent, qualified personnel who can deliver. As you grow, your company will layer in multiple levels and supporting personnel. It is important to consider your structure ahead of time as you build up the areas of function and zero in on the recruitment process.
The difference between Quality Control (QC) and Quality Assurance (QA) is not always clear. Quality Control refers to the process that analyzes every raw material, excipient, intermediate material and finished product, in the laboratory. Quality Assurance is a complex system that includes: Site Master File (SMF), Quality Manual (QM), Main SOPs, Equipment Validation, Process Validation, Cleaning Validation, Computer System Validation, Product Quality Review, Risk Analysis, Audits and Inspections.
The laboratory is both one of the most active and one of the most critical rooms in a GMP facility. The laboratory generates all the quality control reporting necessary to prove the quality of your final products. Laboratories have diverse diagnostic equipment pertinent to your operation, and depending on your budget, these tools can increase self-sufficiency and accuracy. Organizing the lab right is another step in your Good Manufacturing Practice (GMP) approval process that will guide your product quality and innovations.
In the quest to become GMP compliant, design and flow of your manufacturing facility are critical. Mistakes in the design phase will cost money and eventual time loss, so taking this step seriously and planning to the end for every detail must be a top priority. It’s not enough for an architect to draw out what is needed; other factors, such as the flow of people and product should be considered at every stage of designing your facility. The entire process should be created in such a way to avoid cross contamination and move product and people throughout the facility as safely as possible.
The path to facility and product approval in cannabis is a long road that requires attention to detail and proper knowledgeable people to guide the project from start to finish and beyond. There are different levels of GMP approvals, but our concentration will be on pharmaceutical manufacturing, food supplement manufacturing and grow side processing through the series. Keep in mind, GMP, or Good Manufacturing Processes, is are minimum standards set and approved by regulatory authorities to create uniformity of product production and to protect the consumers. In cannabis, we should always strive for higher quality to spread awareness, increase education and speed distribution of products to patients worldwide.