What is Cgmp?
cGMP stands for current Good Manufacturing Practices. The regulations were created by the US Food and Drug Administration under the authority of the Federal Food, Drug, and Cosmetic Act and cover manufacturers of food, dietary supplements, cosmetics, medical devices, and prescription drugs.
cGMP regulations require a systematic quality approach to manufacturing, including the development and implementation of procedures and documentation for the design, monitoring, and control of all manufacturing processes. This quality management system helps to ensure products are made consistently and reliably to product specifications for identity, strength, quality, and purity. Not only does cGMP help businesses prevent hazards such as contamination or errors, it ensures that products are safe for consumers, every time.
Why is cGMP Certification important?
Consumer Safety: cGMP certification helps protect the consumer from purchasing ineffective, contaminated, or inaccurately labeled products. Consumers have an expectation of safety when buying products, and cGMP certification helps increase brand confidence. In the wholesale food manufacturing world no one will even buy your product if your company doesn’t have this basic certification.
Brand/Investment Protection: cGMP certification helps protect the manufacturer and brand from FDA enforcement such as warning letters, cease and desists, product seizures, or recalls. This is the number one risk mitigation for all brands, partners, and investors alike.
Marketing Tool: cGMP certification can be a powerful marketing tool that sets compliant businesses apart from the competition. This certification can be advertised on your website to let consumers know that your business follows a high standard for safety and quality, making your business among the best of the best in the industry.
How can I gain cGMP Certification?
Step 1: Gap Analysis
To begin the process, Allay Consulting will conduct a gap analysis of the facility to get a baseline idea of what the facility already has in place and what it may still need to complete the certification process. The gap analysis consists of a facility evaluation to determine if all required fixtures are in place (hand sinks, for example), as well as a SOP/documentation evaluation to determine the scope of the existing quality management system.
Step 2: Choose a cGMP Certifying Body
The second step is to choose a cGMP certifying body who will conduct the certification audit and issue the certification. Allay Consultants will look at all options available and will work with you to choose the certifying body that works best for your company. Currently, Allay works regularly with six accredited certifying bodies and can help your company choose the best fit.
Step 3: Create SOPs and Documentation
The third step is creating the large number of SOPs and documentation required for certification. Allay Consultants will evaluate and update all existing documentation, and work with your staff to create newly needed documentation. Approximately 50 different SOPs and/or documents are required for cGMP certification, and this can take anywhere from six months to two years to complete, depending on your business’s timeline and budget.
Step 4: Train Staff
The fourth step is training staff to implement all the SOPs and documents. Allay can train on site or create training for your company that your staff can conduct themselves.
Step 6: Certification Audit
The sixth step is the certification audit—the day you’ve been waiting for! An Allay Consultant can be at the facility with your staff to answer questions and take notes while the auditor is on site. If there are any nonconformities or violations, your Allay Consultant will try to correct the issue while the auditor is on site, or if it cannot be corrected on site, a corrective action plan will be submitted after the audit. If too many nonconformities were found during the certification audit, a second certification audit may be required, but this is rare when working with Allay Consulting.
Step 7: Corrective Action Plan Submittal
The final step is submitting the corrective action plan to the certification body for the correction of any nonconformities that could not be corrected during the audit. Allay can assist your company in writing the corrective action plan. Once this is submitted and reviewed, the certifying body will determine if your business is granted a certification.
Step 8: cGMP Certification Approval
If the corrective action plan was approved by the certifying body, your business will receive the cGMP certificate. Congrats!
Are there other certification options?
Allay assists hemp cultivation facilities and hemp product manufacturers achieve USDA organic certification by developing and implementing the SOPs needed to ensure organic integrity from farm to consumer. Allay can interface with the organic certifying body and put together the application packet, as well as conduct an onsite gap analysis to prepare the business for the certification audit.
ISO 9001 is a quality management compliance certification that is geared toward a variety of plant-based medicine companies. This certification helps ensure companies implement a quality management system (QMS) to ensure customer satisfaction and continual improvement. Allay Consultants can assist with implementing the ISO standard through documentation, trainings, and including quality management in the culture of the company.
This is a food safety management standard to help organizations identify and control food safety hazards, at the same time as working together with other ISO management standards, such as ISO 9001. Applicable to all types of producers, ISO 22000 provides a layer of reassurance within the global food supply chain, helping products cross borders and bringing people food that they can trust.
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Allay is comprised of former Denver public health cannabis regulators with over 40 years of collective, regulatory experience. We are the most knowledgeable, professional and effective Compliance Consulting Team on the market. Together we can help you interpret cGMPs and painlessly get through the certification process.
We understand the hectic pace of running a successful cannabis business. We understand that succeeding sometimes means that you don’t have the time to stop and create numerous SOPs, much less implement a robust quality management system. Allay Consulting can do all of your cannabis cGMP for you and more, while you maintain normal business operations.
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