A quality assurance system is a huge undertaking, but many of the components are actually common sense. Sometimes, just interpreting these requirements and breaking them down into systematic steps is all you need to get started. Becoming a GMP facility can take a year, or even more. So it’s important to know where to start. Here are a few tips to help you achieve an effective quality assurance system from the ground up.
One of your first steps should be to assign a QCM or Quality Control Manager. This is a person who will manage your testing lab. They’ll create the guidelines for the testing procedures, as well as specifications, and standards. They will ensure that all these standards are followed and recorded. If there are any issues, these will be documented and then studied to see if the quality of the product may be affected.
Assigning Batch Numbers
Every step of a production process needs to be assigned a batch number. These numbers should be traceable, so that a person could pick up a finished product and know every process that went into the creation of the product – including who did the steps, what day they were completed, and even what other products have the same ingredients. Laboratory samples will also be tracked by these batch numbers. This sample will be from a larger amount of product which will also be stamped with the batch number. This number must be created from the point that the seeds or the clones are first planted. This process can be traced from the seeds and right through the growth, packaging, and distribution. Batch numbers allow for traceability in every step of the process.
Determining Shelf Life
Stability testing will need to be done to ensure shelf life of your product. With the cannabis industry, this can be a tricky undertaking. Often different strains may have different shelf lives. Even the leaves, extracts, and oils can all involve differing shelf life. Even though this may be a difficult compliance to achieve, it’s a necessary part of achieving GMP certification and assigning a scientifically accurate expiration date.
Testing & Approval or Rejection of Products
Only one of two scenarios is going to occur during the testing of cannabis products. One is that the sample will be approved. This allows products of this batch to be packaged and distributed for sale. To the opposite, the products will be rejected and the entire batch will need to be reworked or destroyed. There may be one or more tests that can result in the approval or rejection of products.
Maintaining Good Records
It’s essential to maintain excellent laboratory and production records that can be referred back to at any point in time. It’s part of the QA and QC process in the pharmaceutical industry. It shows that your company is serious about its niche and will take the steps needed for compliance.
Keeping good records must include descriptions of each sample, the source, quantity, dates, batch numbers, and more. If there were any calculations done in testing, they will need to be provided. The analyst, technician, or reviewer must date and initial each step.
Your quality assurance system for cannabis extract manufacturing is going to be one of the most important parts of your business, so it’s best to ensure that you don’t cut corners.