What is GMP?
Good Manufacturing Practices (GMP) is a system for ensuring that products are consistently produced and controlled according to quality standards. GMP was established in the pharmaceutical industry to minimize the risks involved in production that cannot be eliminated through testing the final product. GMPs are an important part of regulatory control over the safety of the nation’s food and drug supply and also serve as one basis for becoming FDA cGMP (the c is for current) compliant. Being cGMP compliant is required for pharmaceutical manufacturing facilities. However, many manufacturers have started adopting these practices since they provide tangible benefits and grant insight into the manufacturing process.
GMP covers all aspects of production from the starting materials, facilities, and equipment to the training and personal hygiene of staff. Detailed written procedures (SOPs) are essential for each process that could affect the quality of the finished product. There must be systems to provide documented proof that standard procedures are consistently followed at each step in the manufacturing process – every time a product is made. Any detail within your supply chain that isn’t operating to a specification you have defined and managed tightly is probably not consistent or efficient, but worse yet, you just won’t know. GMP compliance is widely-accepted as the best way to minimize some risks to the business, putting product quality first.
What does GMP have to do with cannabis?
As evidenced by the number of breakout sessions at MJBizCon dedicated to the topic, inconsistency of product is one of the major problems facing cannabis manufacturers today. Consumers would rather buy from a brand that they know to be consistent. They may have had great results purchasing a product from a specific brand in the past, but if they cannot repeat that experience, it will cause them to lose faith in the brand and avoid it entirely. This is of particular concern to brands that are using multiple facilities to manufacture or cultivate their cannabis products. It would be difficult to overstate the importance of having proven, documented and repeatable processes to ensure consistency across facilities.
Other benefits of cGMP compliance include:
- Compliance – Because GMP was initially created to keep pharmaceutical companies compliant, it is designed for this purpose, it will help cannabis cultivators get and stay compliant with government mandated traceability requirements.
- Quality – it will improve the quality and safety of cultivated and manufactured products. You have hired the right people for the job, their knowledge within their field is beyond compare, now let’s ensure their vision for your products is being realized. This can only be achieved by following a process that is strictly controlled at every step. If you aren’t controlling everything to the most minute detail, the process will have variances that don’t meet your standards. Adhering to standards is the purpose of GMP.
- Risk Mitigation – Failure to follow GMP standards could result in a legitimate public health incident. Cultivators and manufacturers are responsible for massive quantities of cannabis products that will be consumed by the public, and any issue could be amplified by the number of people affected. While cannabis regulations generally require finished product testing, testing alone is inadequate to ensure product safety and quality. End-to-end process controls guard against other issues common in agriculture such as food-borne pathogens like E. coli or Salmonella, foreign materials such as plastic, metal or glass, or even allergens that surreptitiously found their way into the product. While testing is a critical part of any quality management program, it is only one aspect of quality control.
- Create a competitive advantage: Consumers and partners will both respect that your organization has exceeded the minimum expectations set for them. Your reputation lies in the quality of your product and of the talent the organization can attract.
- Ongoing personnel development: An aspect of GMP is maintaining training material to make sure everything is up-to-date. As you continue improving your process, your training material meets or exceeds the set standard, which means your employees are prepared to keep the facility operating efficiently and ready to scale.
- Added credibility: being cGMP compliant proves your organization’s credibility among consumers. Regulators will see that your organization has taken the steps to ensure product safety through lot-specific documentation. While end-consumers may not be aware of this in many situations, distributors and dispensaries will likely be aware of your commitment and have greater loyalty, and a track record of quality will drive demand for your product.
- Business insights: being cGMP compliant will require your organization to thoroughly document all procedures related to the manufacture of your product (SOPs). Having this process thoroughly documented will grant insight into hidden cost factors as well as how the entire operation could be improved.
THC content is the primary driver of price right now, but that is a holdover from the black market days where higher potency basically just meant more bang for the buck. Consumers are getting more sophisticated and they know what terpene profiles they want. The number one complaint consumers have is that they cannot consistently repeat their effects when consuming the same product. Growers that can deliver that product consistently are the ones that will still be here in 10 years.
A note about cGMP Certification vs Compliance
While the FDA requires manufacturers within certain industries to register with them, they are only able to inspect facilities periodically. Even when they do inspect, the FDA only cites cGMP violations needing corrective action or they may place restrictions on the facility. They do not however certify or decertify facilities.
Being cGMP compliant requires the facility to comply with a number of standards including strong quality management systems, traceable product records, appropriate quality raw materials, robust operating procedures, product quality assurance and control, and reliable testing procedures. To be cGMP Certified however, a facility must be compliant and also formally retain a 3rd party auditing firm to inspect their facilities and certify that the facilities and certain IT systems are actively meeting or exceeding cGMP standards. This audit is not cheap or quick. It requires a high level of commitment by the manufacturer to pass this audit and be certified. With that in mind, it is usually a good idea to work towards cGMP compliance first and then down the road an organization may decide to get their facility certified when it is deemed the return will justify the effort.
cGMP Compliance – The Basics
Anyone familiar with submitting plans to a Department of Health for a food manufacturing facility or commissary knows there are very specific requirements and regulations. As an example, it is common to see that refrigerators must operate at 41 degrees, countertops have a 3.5 inch backsplash, hot water of 120°F is available at all sinks, Pass-thru windows are limited to a maximum of 216 square inches, and on and on. Very specific instructions for what will be required that can then be consulted while the facility is architected.
However, when it comes to cGMP compliance, the requirements are far more objective oriented. As an example, here is a section of Part 211 for FDA CGMP Certification for finished pharmaceuticals.
As can be seen, the requirements are broad but not at all deep. This puts the onus of meeting these requirements on the business. If we look at Sec. 211.42.c (4) it simply states; “Storage of in-process materials;”. This does not provide specific instructions or limit what a manufacturer can or can’t do within their facility. To meet the GMP objective the manufacturer must use process and documentation to prove that they are providing a location for the storage of in-process materials, along with material control [systems] that has “adequate space for the orderly placement of equipment and materials to prevent mixups between different components, …, and to prevent contamination.” This is a springboard for designing all aspects of stockrooms, inventory transactions, lot-control procedures, and data.
As stated by the FDA:
“The CGMP requirements were established to be flexible in order to allow each manufacturer to decide individually how to best implement the necessary controls by using scientifically sound design, processing methods, and testing procedures. The flexibility in these regulations allows companies to use modern technologies and innovative approaches to achieve higher quality through continual improvement. Accordingly, the “C” in CGMP stands for “current,” requiring companies to use technologies and systems that are up-to-date in order to comply with the regulations. Systems and equipment that may have been “top-of-the-line” to prevent contamination, mix-ups, and errors 10 or 20 years ago may be less than adequate by today’s standards.
It is important to note that CGMPs are minimum requirements. Many pharmaceutical manufacturers are already implementing comprehensive, modern quality systems and risk management approaches that exceed these minimum standards.”
How to get cGMP Compliant
Any effort in moving towards cGMP compliance will require personnel knowledgeable in GMP standards and methods. Ensuring strong quality management systems, traceable product records, appropriate quality raw materials, robust operating procedures, product quality assurance and control, and reliable testing procedures will require experience and knowledge. If your organization does not employ experts with these skills your options will be to hire someone or train existing personnel.
A GMPCP (Good Manufacturing Practices Certified Professional) certification will impart all of the information required to operate a cGMP facility. A GMPCP covers a range of topics related to GMP and everything that goes into creating a cGMP certified facility, from understanding how to document procedures to training employees.
Standard Operating Procedures (SOPs) are issued to specifically instruct employees in areas of responsibility, work instructions, appropriate specifications and required records. SOPs outline procedures, which must be followed to claim compliance with GMP principles or other statutory rules and regulations.
An FDA Notice focusing on specific recordkeeping requirements in the Federal Register gives a very good summary of SOPs required by 21 CFR Part 211:
“Written procedures (standard operating procedures – SOPs), are required for many Part 211 records. The current SOP requirements were initially provided in a final rule published in the Federal Register of September 29, 1978 (43 FR 45014), and are now an integral and familiar part of the drug manufacturing process.”
The 25 SOPs provisions under Part 211 include:
- Section 211.22(d)-Responsibilities and procedures of the quality control unit;
- Section 211.56(b)-Sanitation procedures
- Section 211.56(c)-Use of suitable rodenticides, insecticides, fungicides, sanitizing agents;
- Section 211.67(b)-Cleaning and maintenance of equipment;
- Section 211.68(a)-Proper performance of automatic, mechanical, and electronic equipment;
- Section 211.80(a)-Receipt, identification, storage, handling, sampling, testing, and approval or rejection of components and drug product containers or closures;
- Section 211.94(d)-Standards or specifications, methods of testing, and methods of cleaning, sterilizing, and processing to remove pyrogenic properties for drug product containers and closures;
- Section 211.100(a)-Production and process control;
- Section 211.110(a)-Sampling and testing of in-process materials and drug products;
- Section 211.113(a)-Prevention of objectionable microorganisms in drug products not required to be sterile;
- Section 211.113(b)-Prevention of microbiological contamination of drug products purporting to be sterile, including validation of any sterilization process;
- Section 211.115(a)-System for reprocessing batches that do not conform to standards or specifications, to insure that reprocessed batches conform with all established standards, specifications, and characteristics;
- Section 211.122(a)-Receipt, identification, storage, handling, sampling, examination and/or testing of labeling and packaging materials;
- Section 211.125(f)-Control procedures for the issuance of labeling;
- Section 211.130-Packaging and label operations, prevention of mixup and cross contamination, identification and handling of filed drug product containers that are set aside and held in unlabeled condition, and identification of the drug product with a lot or control number that permits determination of the history of the manufacture and control of the batch;
- Section 211.142-Warehousing;
- Section 211.150-Distribution of drug products;
- Section 211.160-Laboratory controls;
- Section 211.165(c)-Testing and release for distribution;
- Section 211.166(a)-Stability testing;
- Section 211.167-Special testing requirements;
- Section 211.180(f)-Notification of responsible officials of investigations, recalls, reports of inspectional observations, and any regulatory actions relating to good manufacturing practice;
- Section 211.198(a)-Written and oral complaint procedures, including quality involving specifications failures, and serious and unexpected adverse drug experiences;
- Section 211.204-Holding, testing, and reprocessing of returned drug products; and
- Section 211.208-Drug product salvaging.
Procedures can take the form of a narrative, a flow chart, a process map, images, computer screen printouts or combination of all or any other suitable form, however must be written in appropriate, effective grammatical style. (e.g. plain English and/or other relevant language for the workforce). SOPs need to be thorough and should account for all eventualities within a process.
It is also critical that SOPs are versioned and managed according to a policy and enforced by members with the appropriate role within the organization.
Depending on the role of the employee using an SOP, they may be required to have thorough knowledge of and be able to recite the SOPs relevant to their job. Other roles with higher turnover and less intensive employee training should have access to SOPs that they can refer to while doing their job. For facility workers in the greenhouse or processing floor that will usually be the software application in which they receive their tasks. If an employee is tasked with topping cannabis plants, from within the task tool they should have access to the SOPs for that task which will provide clear instruction with photos.
This example of an SOP is a framework that would be adapted to describe the company’s specific procedures, and is only shown as an illustration of its detail and structure.
Attempting to attain and enforce cGMP compliance without an enterprise-spanning software platform would be prohibitively difficult. Even just keeping your SOPs versioned, up to date and available to your workforce would be a massive undertaking with plenty of overhead and not realistic without a software solution.
In order to effectively track the location and movements of your raw materials, harvests, labels, intermediate and finished goods, a robust inventory system capable of tracking items by cultivation batch and production lot is a bare minimum. If your organization is currently using spreadsheets or whiteboards to track anything then that will be the starting point for finding processes to be improved with a central database. For the most part, if a task requires a spreadsheet to track activity or results, the process is open to errors. Mission critical data needs to live within software specifically designed to handle it. If you are using separate software applications to handle different portions of the manufacturing chain then those applications should integrate to exchange data freely without the use of spreadsheets. Your organization will either outgrow spreadsheets or not, but pursuing GMP requires a more advanced platform.
Having dedicated software to make your processes run smoothly while providing corporate visibility is important and any organization looking to become cGMP compliant will need a unified software platform that integrates all business units. Ideally your organization will have a consolidated software platform that will provide a single pane of glass view into:
- Inventory management
- Regulatory integration
- Knowledge base / document management
- Quality management
- Facility Asset management
- Skills/Labor management
- IT service management
- Vendor/partner management
When thinking of the effort involved in making your facilities cGMP compliant one can be forgiven for focusing on how daunting the process appears. However, after consideration it should become obvious that working towards cGMP compliance and growing your business to scale efficiently go hand in hand and depend on the same steps. Providing the highest quality products possible and insulating your organization from risk should be core components of any business plan. For this reason, whether you consider it as getting cGMP compliant or preparing for profitable growth, your plan should be the same.
The Regrow platform is designed for businesses that run efficiently and profitably while maintaining compliance with government regulations. If you would like to see the platform in action, and how it can help you get cGMP compliant, click here.
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