Many hemp processors wonder what they need to do to comply with the many regulations that some states are implementing to meet GMP certification. Extraktlab has spent the last several years putting many companies into the business of hemp extraction and have tremendous amount of experience setting up processes and procedures that address regulatory requirements. If you want to meet GMP certification for your operation, there are 10 requirements you need to attain a firm understanding of.
10 Requirements for GMP Certification
In our experience the requirements change based on geography and on company initiative. Following list is a summary of some of the key requirements for GMP certification and compliance you need to keep in mind:
- Third Party GMP Certification
- Standard Operating Procedures (SOPs) for each process to support the overall Quality Management System (QMS)
- Quality assurance and quality control standards must be established
- Obtain and Record Batch Data such as testing results, chain of custody, ingredient lot numbers and waste records
- They must maintain records such as testing results, traceability, chain of custody, batch and lot numbers and waste records.
- They must maintain sanitary and safety standards
- They need to provide COAs and proper sampling of finished goods
- They must maintain equipment records
- They need to be able to produce and report on these records upon request
- They need to establish security provisions to reduce or eliminate diversion
1. Third Party GMP Certification
What this means is that the processor will have a third party come in to do a gap analysis and audit all of their SOPs, building and quality records. They'll also look at the training, maintenance records and identify gaps that the processor has in their SOPs.
One consideration that each company must decide is which GMP standard to apply. in Canada, it's straightforward since there is a federal law. However, in the United States, different states apply their own standards, so it is important to check the state to see which GMP regulation they want to apply.
Another consideration is to select a GMP standard and become certified to that standard. For example, maybe the processor wants to be a nutraceutical manufacturer. In that case, they would have to go into the federal code and look up 21 CFR Part 111 to identify the factors they will follow to be GMP compliant in that field.
At that point, they would tell their auditor what GMP certification they were looking for and allow them to audit the facility, processes, people and training records for that particular standard. After evaluation, that processor can move forward with their plans to receive GMP certification in their particular area of choice.
After identifying your GMP standard and getting a GMP auditor for that standard, Step is to do a walk-through with your auditor. The walk-through can be done online. This will help the auditor understand the gaps that may be in the process.
The next step after that is simply to gather all of your documents. If you have a Quality Assurance or Quality Control manager, they are the go-to people for documentation. They will present to the GMP auditor your SOPs, training and employee records.
If you don't have any records and you are just starting, that is also not a problem. The auditor can give you a clearer picture as to what you need to put in place and also set you up with documents and processes to use those. Typically, they would like to see you working the quality system for several months before a full gap analysis.
If you don't have a Quality Assurance Manager, using a Quality Management System like the igwLAB will allow you to gather and contain all the training, maintenance, calibration, traceability, maintenance records, batch records, certificates of authenticity and certificates of analysis all in one software package designed for your operation
2. Standard Operating Procedures (SOPs) for each process to support the overall Quality Management System (QMS).
Standard Operating Procedures, or SOPs, are written documents that encompass your entire quality system. When people think about SOPs, they're often thinking about manufacturing.
This may include the Steps of production or the recipe, the standard procedure to be used to produce a particular product, and SOPs on document control, corrective action, and rework. It also encompasses chemical hygiene, sanitary and safety protocols as well. So, you really need to be thinking about SOPs as encompassing your entire business.
In fact, a lot of people who are ISO or GMP compliant often have business processes that come in, like inventory management for example. So, it is necessary to identify the key SOPs that you need to comply with in the regulatory aspect of your business and get those SOPs into a document control system.
The document control system will then help you to maintain those changes. Oftentimes, you have a set of recipes, and you're constantly making changes to them to really fit your business. All those changes need to be documented and signed off according to a process.
One of the things that's great about IGWLab is that it has a document control event manager incorporated into the software. This allows you to load up all your recipes into the software and assign them to different work cells.
This is a useful feature because you are able to access your recipes and SOPs right at the work cell all the time. So, there are many things that you can do with a quality management system like the IGW Lab that really helps streamline the SOP requirements.
3. Quality Assurance and Quality Control Standards Must be Established for GMP certification
The third requirement is a Quality Assurance (QA) and Quality Control (QC) standards for your process. Processors often need to consider the standards that they will need for their end product and some of those are statutory.
For example, if a processor is in the hemp production world their end products have to contain less than .3% delta nine weight per weight. But there are other quality considerations that cannot be ignored.
For example, it is critical to know if the end product is pesticide free, free of metals and effective overall. To pass pesticide or metals stipulations, the product has to be tested for purity potency and identity and has to match the label.
And, the purity has to be a certain purity. Sometimes there are limits on the total number of cannabinoids that are available that can actually be used in a final product. So, it is essential to test for all those factors. You also need tests for in process materials.
For example, if you're an extractor with a large amount of crude oil coming in, you need to make sure that you have tests for those. And all of those tests are really warehoused in one place.
So when considering quality assurance and quality control standards, you’re actually identifying a set of accepted criteria that indicates a product either passes or fails your decided standard. If it does not pass your standard, you may need a process either to bring that product out to waste to discard it, or to rework the product if possible.
A QA manager will often take the results from the QC laboratory, and decide whether or not the product does not pass and they'll put it into quarantine. From there, they can put a label on it so that the person can either rework it or discard it.
One thing about the IGWLab that is very useful is that you can put all of your tests and accepted criteria into the software and you can order up tests according to a sampling protocol, which is also in the software.
4. Obtain and record batch data such as testing results, equipment used, quality checks, chain of custody, ingredient lot numbers and waste records
The fourth requirement lies in record keeping. This is where things can start to get complicated. It is essential to ensure that your testing equipment, where you are testing and all of the items within the lots that you're testing are warehoused into a place so that they are organized to avoid confusion.
For example, if you’re testing for purity, potency and identity at the very beginning when receiving biomasses, making an inventory location in the middle of a process, testing the formulation process to see whether it passes your specifications, or testing the final goods product - all of those are related to a single lot that comes from the same biomass.
You need to be able to trace all those tests back and connect them to that single lot. That can get very confusing for people who are starting out if they don't have a Laboratory Information Management System (LIMS), or sampling protocol that would indicate the records that are needed to keep and how all the testing fits with a particular batch.
One thing that's effective about a LIMS like the IGWLab software, is that it has a sampling and the testing protocol is built right into it. So the information coming out of the laboratory is directly input into the IGW software by the laboratory, and that's automatically connected to your lot, which completely streamlines your process. The second record that you need to keep is the location source of your biomass.
For example, if you bring the biomass into your operation, and it's coming from Oregon, Texas, Florida, New York, or Nebraska, you need to be able to keep records of the lot. You need to be able to keep records of the farmer as well as their licensing information, where they're licensed from, how it was transported and the chain of custody.
Typically, they will provide you a set of documents with those necessary records. Typically, you would scan those documents in and keep them on your own; however, an MES like the IGWLab is capable of maintaining all of that for you in a receiving process.
When everything you're receiving is in barcoding, now all of the MSDS is yours. If you are, for example, checking chemicals like ethanol, all your information is scanned in your MSD information scan. This connects to anything that you make with that particular product via a barcode.
The third level of records necessary to maintain is the batch of a lot number and the ability to trace that all the way through the process. Suppose you have 10,000 pounds of biomass that you intend to extract and create distillate.
Then you’re going to use that distillate to create various products with it like vapor pens, gummies, cosmetics, or tinctures. You need to be able to trace the lot number that's on that final product back to the biomass.
The fact of the matter is that keeping a quality batch record of plant to product processing with a paper trail is incredibly difficult to do. There are instances in which a processor may want to blend biomass together.
Suppose a processor might have four different lots of four different biomasses coming in that will be combined and extracted into one batch of crude oil in one lot. Then that crude oil lot is broken up into isolate, distillate, and perhaps broad-spectrum extracts.
For this reason it is highly recommended to invest in an MRP system, and also manufacturing execution system like the IGWLab. This allows for a far superior traceability from biomass to final product as opposed to keeping those records on paper.
The last record to keep is waste records. Every process itself has some waste and it is necessary to keep records of that waste production at every process level. There are SOPs for the manifestation of that waste and the disposal of waste and it is important to consider those documents.
Other records that are important along these lines are sanitation records, cleaning records, maintenance and calibration records, and safety records, all of which can be created, monitored and streamlined using a system like the igwLAB.
5. Provide facilities & processes that comply with safety and sanitation requirements
The next requirement to consider for GMP compliance is establishing sanitary and safety standards for your facility and workers.
These standards are incorporated into all GMP processes and are closely associated with cleaning records, validation and methods. If you don't have an SOP for a cleaning method and that method has not been validated that it works, we can now implement a test that validates when you have cleaned something, then you’re taking actual data that confirms you actually cleaned this piece of equipment.
Those are the things you really need to be considering when you're thinking about sanitation. That can go for any object - even the floors, walls or the ceiling. You could, for example, barcode the ceiling.
And in IGW, you can record an event that indicated, you cleaned the ceiling. By scanning the barcode you could show who and when the ceiling was cleaned and for what purpose. This can be applied for any maintenance or safety process in your business.
Another convenience to an MES system like the IGWLab in terms of cleaning and sanitary rules and methods is the capability to put all of those sanitary and cleaning methods, protocols and SOPs directly into the actual operation itself.
This allows the MES system to act as a quality control system that will ensure your equipment is calibrated, cleaned and ready for use for any particular process like converting crude oil to distillate. It will also know who is operating the process, at what time, how long the process took, what room the process took place etc.
This level of record keeping ensures that sanitary and safety standards are recorded from beginning to end as opposed to standard paper record systems that are less detailed and less prevalent when recorded by your operators.
6. Provide Adequate Training and Maintain up-to-date Training Records
Safety and training records are also critical for GMP certification and compliance. In order to streamline this process, all of those training records should be warehoused in the IGWLab or other MES as events.
When an operator is entered into the IGW they will be provided a number or log in, which they will have to use to log in every time. When they do that, the system knows that they’ve logged in and that they have done all of the operations and when they logged out.
Oftentimes, the system will log the operator out automatically, as according to what's required by 21 CFR Part 1. This is all for data integrity purposes.
So the training records are important to be warehoused in the system so that when an inspector comes in, they can be provided all the training IDs indicating the operators have been trained according to this GMP, they've been trained in this chemical hygiene, etc.
And if they have other specific training like this IGW training, for example, or if they have other training, like GMP training apart from the lab and training all the certificates within the warehouse, oftentimes if you have an HR person they will warehouse that as well.
So, maybe the HR person wants to use the IGW as a part of warehousing for that, usually the quality system however, will require that the training records are maintained.
7. Provide Accurate and Consistent Sampling and Analytical Testing before, during, and after production for GMP Certification
The seventh requirement involves providing certificates of analysis and sampling protocols. When you have oil, and you are bringing it into products, or if you have biomass and creating oil from it, you always have to have some sort of certificate of analysis.
Now, the certificates of analysis can be both internal or external. Typically, you want to have a Third Party Certificate of analysis for the products that are actually going out into the consumer world.
When identifying a third party to submit your product to for evaluation, you should look for an ISO 17025 laboratory that's been certified and they're certified to run the particular tests you need for GMP certification of your product.
From there, you can request a pesticide test, a potency/purity/identity test, a metals test or any other tests necessary to make sure your products are meeting the specified requirements.
Oftentimes, a manufacturer will require a third party test if they're buying their biomass from a third party. If that is the case for you, it is necessary to warehouse that in your system, but in between that you are always testing, especially at the formulation side to make sure that your formulation is what you say it is within the label plane.
This ensures that when you send out your product , you don't package all your formulation before you actually get the data back from the third party analysis. You also want to have those test results attached to your batch record.
8. Maintain equipment, method and validation records
The next requirement is calibration, maintenance and equipment records. Every time you have put a piece of equipment into your facility, that piece of equipment has certain requirements to it - and this isn’t limited strictly to equipment.
If, for example, you have a spoon and you are going to bring that into an assignment what are the requirements for that spoon? Does it have to be stainless steel? Does it have to be polished? Do you have to clean it? How often do you have to clean it? Those are all things that have to be identified ahead of time for all equipment in the process.
When you're talking about equipment, you're talking about a set of specifications associated with the equipment that you're using in your facility. A lot of the time when employees use equipment, they also have calibrations associated with them.
Whether you're making a temperature measurement, humidity measurement, or you're using the scale, those things typically need to have calibration usually performed on a yearly interval. By doing this, a third party can certify this piece of equipment as working for you when they eventually come to evaluate it.
Usually, when you're running your process, you need to verify that your calibration is actually what it says it is. That would be a test weight.
Suppose you have a scale, and you want to make sure that it's within calibration. You would have a test; you’d put it on the scale, verify it and put that information in your IGWLab. This would allow you to verify that you’ve calibrated the machine before you got started using it in your process.
You’re also able to put maintenance intervals in your system as well. Some of the equipment that you might put in there would have to be maintained according to the manufacturer specifications.
For example, if you had six pieces of equipment in your facility equipment records and one of them was to be maintained on a six month regular basis, that could all be warehoused in your QMS. A notification can then be set to indicate that it is time to maintain this equipment according to the manufacturer's specification.
Not only does this ensure that your equipment is well maintained for your processes, it also automatically keeps record of your maintenance allowing you to easily produce specific equipment maintenance records wherever necessary
9. Provide Accurate Documentation and Reporting for quality records upon requests
The ninth requirement to note is related specifically to reporting. It is essential to be able to take the data that you get from your system, or from your paper trail, and report on that data.
This is important, for example, to ensure that you can find all the chemicals and the location of the chemicals that have an expiration date two months from now, or to provide a list of all the people who have been trained according to a particular SOP, or provide a comprehensive idea as to the waste manifest for each particular operation or process.
This would allow for an efficient evaluation of bottlenecks in your process like why operator A has twice as much waste as operator B? Or, why it takes five times as long for operator A to run the process versus operator B. That's what reporting and data is all about and warehousing all of that data that you can in a system like IGW that really helps you drive efficiencies.
10. Address security provisions to reduce or eliminate diversion
The last requirement for GMP certification is to identify, reduce or eliminate diversion events. For example, maybe operator A checks out 10 kilos of material in the process, and they only check back in one kilogram of material, but they're supposed to check in eight kilograms of material according to the normal waste.
This could be a clear indication of a diversion event. Oftentimes, if there is any resistance to using a logging system like this, usually, there's something else going on. Operator A may likely be doing something and taking material under the table.
These are things that your cost accountants and your management absolutely need to know to avoid this kind of action. This allows an auditor to have a good experience when they walk in. You will easily be able to supply your software, run a report, or any other action that they require without any concern whatsoever.
The fact of the matter is that GMP certification is a necessary aspect of any successful hemp processor's operation, and attempting to keep these 10 requirements in check via papertrail is archaic and inefficient. If your are interested in using a QMS, MES & LIMS system built specifically for the hemp extraction industry, the igwLAB is the way to go. Give us a call at: 651-600-0036 to take get your operation GMP certified with ease and efficiency today.