Deciding to become GMP certified is a crucial first step, but before embarking on the journey it is imperative that a cannabis supplier or manufacturer is both prepared and understands what is required for GMP certification. Failure to plan properly and allocate the necessary resources can have a significant detrimental impact upon a business. Getting the GMP certification process right will save time, money, and resources, and can be highly advantageous for a company involved in the cannabis industry. Not only does it allow greater market access, but it also helps to reinforce the quality and reliability of the product being sold. Here are some important steps and considerations that companies should take into account as they get ready for GMP certification.
Getting a GMP specialist
When first considering whether to gain GMP certification, it is important to have an experienced specialist to assist you. This GMP specialist can be an internal or external resource and is essential to navigate the intricacies of GMP legislation and compliance. This person should have the skills to be able to conduct a gap analysis and report their findings. This process will identify the gaps between current processes and GMP requirements and provide recommendations to get the business ready for certification. It is far more efficient and effective to identify gaps early as implementing GMP retrospectively can incur significant costs. Knowing the cost and effort required to obtain GMP certification upfront allows for effective planning and minimizes the overall cost.
GMP covers all aspects of production from the raw materials, facilities and equipment, to the training and personal hygiene of staff. GMP requires that a business carry out a risk assessment of all their processes, identify areas that contain potential risks, and adopt strategies to minimize their occurrence. High risk areas identified from the gap analysis will require a larger qualification and validation effort than areas deemed to be lower risk. Typically identified high risk processes include manufacturing equipment, facilities, and personnel that work directly or closely with product. The areas of risk will differ between different manufacturers and suppliers, so it is important to understand all processes and the risks each pose.
Becoming GMP Certified
Gaining GMP certification requires a cannabis supplier or manufacturer to complete a GMP audit process. The auditors will be representatives from the regulatory authority for which the business wishes to gain certification, and the auditor’s agency will differ between jurisdictions. For example, the Food and Drug Administration (FDA) GMP inspection will be conducted by an auditor from the FDA. In the EU, while the European Medicines Agency (EMA) will coordinate inspections, the inspection itself will be carried out by a national authority in one of the EU member states. Here in Canada, to gain EU GMP certification an auditor from an EU member state will complete the audit.
Following the inspection, an audit report is produced stating whether or not certification has been achieved and provides corrective actions to be taken where it has not.
Every effort is made to ensure auditors are consistent in their interpretation of regulations. Even so, the individual auditors’ readings and inferences are subjective – what one auditor might find acceptable another may not. It is important to note that such discrepancies are uncommon and where they occur, processes have been established for resolving any potential audit disputes.
Maintaining GMP Certification
Maintaining GMP certification is important in ensuring continued market access and product accreditation. This can be achieved through measures such as properly maintaining equipment and facilities, following standard operating procedures, and ensuring GMP documentation is in order and available to inspectors. GMP auditors can conduct both scheduled and surprise inspections to ensure manufacturers or suppliers remain compliant. Failure to comply with GMP regulations can result in severe penalties such as shutdown of manufacturing facilities, seizure or recall of product, and even criminal investigations and lawsuits, all depending on the level of non-compliance. While it is possible to re-gain GMP certification or to fix any non-compliance issues, depending on the financial implications of the penalties imposed, for smaller businesses it could lead to failure of the business.
As more businesses within the cannabis industry look to implement GMP, manufactures or suppliers that follow suit will not only increase their business opportunities, but will also develop a reputation of excellence in the quality of products they produce. The need for GMP certification will soon increase as it appears GMP will become the standard for medical cannabis products and potentially for recreational products as well. Understanding what is involved in the GMP process is essential for a company looking to become involved in this space.
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