As States begin to legalize and regulate the Cannabis industry, important considerations must be addressed. One of these is the development and implementation of Good Manufacturing Practices (GMPs) and a quality system that meets the new state regulations. While not all state regulations are the same, some are similar to the food industry and others more like dietary supplement and pharmaceutical GMPs, the expectation across the board is that facilities throughout the supply chain will have these systems and be closely monitored.
Navigating these regulations and establishing GMPs can be very challenging, particularly for a new industry. Let EAS’ team of Independent Consultants, experts in food, dietary supplement, and pharmaceutical GMPs as well as state regulatory requirements, assist your team with interpreting the regulations and determining how best to comply. We’ll help you develop compliant quality and manufacturing procedures, policies and systems that are best your business.
Like any FDA regulated industry, states that allow the production and sale of legalized cannabis products will require the products to be manufactured in accordance with sound Quality Management Systems and Good Manufacturing Practices including, but not limited to:
- Production and Process Controls
- Laboratory Operations
- Quality Investigations of Non-Conforming Materials and Product
- Managing Returns, Complaint, and Recalls
- Specifications for Raw Materials, In-Process Materials, and Finished Product
- Sanitation Practices and Controls including environmental Monitoring
- Product Traceability
- Inventory Controls
- Waste Divergence
EAS Offers comprehensive auditing services including reviewing SOPs, Company Organization and Personnel Training Programs, Facility Audits which include Gap Analyses
- Mock-FDA Inspections
- Contractor Audits
- Site Security Systems
A product recall is a time-consuming and expensive endeavor but is required whenever a regulated product is found to be either defective or potentially harmful. Recalls can be warranted for a failure of a product to meet safety regulations, the FTC may request a recall if label or website claims do not meet appropriate levels of substantiation, or a product’s packaging is not in compliance. Whether the recall is voluntary or requested, the recalling firm must have a procedure in place to ensure all violative product is removed from the marketplace.
From ingredient/component suppliers to manufacturing/processing/labeling, to the distribution of the products within the U.S. market, firms should take a proactive approach to ensure the safety of their product and reduce the potential for a recall. EAS can assist with the performance of a mock recall to assess your readiness to execute an actual recall.
In the unfortunate event of a recall, EAS consultants can advise on the recall process.
As states begin to regulate legalized cannabis, the concern of how Good Manufacturing Practices (GMPs) apply to this unique industry cannot be understated. While regulations vary from state to state the quality systems under which cannabis products are grown and manufactured have similarities that can begin to pave the way for putting practices and procedures in place to meet compliance expectations, including those of testing and quality control of in-process materials, finished batches and packaged/labeled products. The time is right for the Cannabis industry to begin assessing your manufacturing processes and implementing sound and effective quality systems in order to help you begin to prepare for GMP regulations. Stay ahead of the curve, standardize your product quality and be a leader in your industry.
EAS is frequently requested to bring our popular public training programs in-house, offering a dedicated training for employees and customizing the content as-needed to focus on specific areas of need. Let bring one of our in-house training programs to your facility, customized for your specific needs, or join us at one of our upcoming training programs coming to a city near you.
- Quality System for the Cannabis Industry
In the industries regulated by FDA, such as those in the pharmaceutical, medical device, food, dietary supplement, and cosmetic business, compliance issues are of great importance. When disputes arise, the regulatory compliance status of a product or facility is often a key issue and can make a significant difference in how the matter will be resolved. In such cases, it is critical to have the assistance and advice of experts who are both experienced and knowledgeable in FDA regulations and industry practices, and who will be perceived as independent and objective. Whether a dispute is resolved via mediation or litigation it is imperative to have a well-respected and knowledgeable expert witness acting on your company’s behalf. EAS independent advisors and consultants are routinely called to serve as expert witness in a variety of cases and provide the in-depth, detailed attention required in these cases.
EAS offers one of the most experienced groups of consultants available on FDA regulatory compliance issues. We offer a team of over 70 former high-level FDA officials and industry professionals who will share their expertise with our clients. Our consultants have an average of over 25 years of regulatory experience and include some of the most well-known and highly respected names in the industry. As new standards and regulations proliferate, EAS keeps abreast of the changing regulatory landscape, allowing us to deliver up-to-the-minute policy advice to our clients. Our experts have the knowledge, qualifications, and experience necessary to explain and clarify the issues to our clients and the courts while establishing credibility and persuasiveness as witnesses.
EAS offers assistance in adjudicating insurance claims and servicing as an expert in depositions and civil litigation cases. With high-level experts in all areas of FDA regulations, EAS is well recognized as representing the industry in all manner of court cases.
In the event that FDA issues a 483 or warning letter or the Department of Justice files a consent decree, EAS can assist with a timely and appropriate response. EAS also assists as a third-party expert for review, audit, and evaluation of facilities and documentation, and can formulate a remediation plan and response in compliance with FDA requirements.