With the movement towards legalization worldwide, the hemp industry is trending towards more facilities practicing Good Manufacturing Practices (GMP). However, as much as those three letters are thrown around, there still seems to be an air of mystery around what GMP actually entails. This is understandable, as it can be difficult to get a straight answer from online searches, or even from reading government standards. The goal of this article is to decode a bit of what GMP is, and explain what purchasers should know when shopping for equipment for GMP facilities.
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In general, GMP is a system to ensure the safety and quality of products. This is achieved through strict control and documentation at each step of a production process; ensuring that starting materials are of suitable quality, are only in contact with suitable equipment, handled by suitably qualified personnel, and create a suitable quality end product. These practices are typically defined and regulated by government agencies (i.e. FDA, Health Canada, EMA). These agencies lay out standards which facilities can be certified to; for example, you have likely seen large companies announce that they have received Eu-GMP certification.
As it pertains to equipment, these standards say that equipment must not allow contamination of products, so equipment should be cleanable and not additive. On the surface, this makes sense and seems to be simple enough. However, GMP is like an annoying (slightly germaphobic) little brother who keeps asking “how do you know?”.
“How do you know that surface is clean? How do you know those gaskets aren’t leaching? How do you know you’re not getting cleaning chemicals in your product?”
This is where validation comes into play. Validation is perhaps the most critical aspect of a GMP process. Essentially, you need to prove that everything is clean and contaminant free, through use of Standard Operating Procedures (SOPs), documentation, and quality control. This can become onerous pretty quickly with poor equipment selection. For example, one colleague who used to sell GMP equipment told the story of how they used to have threaded levelling feet on their machine. They found out months later that, in order to validate their process, a client of theirs had been forced to write an SOP where someone had to get down on the ground and clean the threads with a toothpick. While that technically works and is part of a validated process, it is obviously a waste of time and money to have employees cleaning nooks and crannies of equipment. If you think of this time spent on every piece of equipment, in multiple places, it is easy to see the importance of selecting well designed GMP equipment.
GMP equipment typically should be designed in compliance with a separate, more specific, standard than those laid out by government agencies. Some examples of these standards are:
- 3A Sanitary Standard
- EHEDG (European Hygienic Engineering and Design Group)
- ASME BPE (American Society of Mechanical Engineers - Bioprocessing Equipment)
3A and EHEDG tend to be used more for food processing applications, while BPE is geared towards manufacturing products using biologically sensitive materials. These standards go into detail on just about every aspect of equipment design, such as what style components and fittings you can use, what materials of construction are allowable, down to details such as allowable surface roughness and minimum angle for drainability on lines.
At Yellowstone, we follow the ASME BPE standard for our GMP equipment design, as it ensures that our equipment will be able to be implemented in just about any facility.
Strict adherence to a sanitary standard allows us to design equipment that is easily validated in a GMP facility, without the need for complicated SOPs.
In addition to thoughtful design, validation requirements apply throughout the manufacturing process. GMP equipment manufacturers should supply customers with a comprehensive Turnover Package containing all the documentation to prove the equipment was manufactured out of suitable materials by qualified personnel. A turnover package should include:
- operation and maintenance manuals
- certificate of materials for product contact surfaces and surface finishes
- certificates of calibration for critical instruments
- welding documentation
- testing and examination documentation
Comprehensive turnover packages help the end user easily validate equipment and write SOPs.
Purchasers should be looking for equipment suppliers who follow an established standard such as GMP, offer a comprehensive turnover package, and are flexible in their design. Depending on a company’s goals and the standard they are adhering to, its requirements for GMP can change. For example, some facilities will require a certain surface finish on all stainless steel, or certain certifications on elastomers, while others have less stringent requirements. It is important to engage with experts in order to figure out your exact needs, as GMP does not mean any one specific thing.
In our interactions with consultants, experts, and reading the BPE standard, there remain a number of uncertainties. Because it is ever changing, GMP can appear somewhat mysterious and confusing, however selecting proper equipment for your process makes things a lot simpler. A manufacturer who is adaptable to your needs, provides a cleanable machine, and a comprehensive turnover package will make your GMP approval process much smoother.
Interested in buying GMP? Contact us today for a quote on one of our GMP models.Request a Quote