When you run a GMP production facility that includes cannabis and dietary supplement products, there are certain processes that you must follow in order to achieve government compliance. Cannabis products should follow similar guidelines in food processing and the pharmaceutical industry. This includes qualifying equipment before using it to produce food or medicine.
What is IQ, OQ, and PQ?
These are acronyms related to actions that must be taken when implementing a new process, whether it has never been done before or it is being drastically altered. IQOQPQs are a common industry term used in FDA, ISO and Health Canada. They generally refer to equipment, but also apply to utilities, instruments, and systems.
IQ means Installation Qualification.
OQ means Operational Qualification.
PQ means Performance Qualification.
Why Is It So Important?
These qualifications are in reference to the type of equipment that you’ll be using on your cannabis or dietary supplement production line. It’s important to understand design specifications, as it helps you to not only understand the exact materials and processes involved in their production, but also what type of power source and procedures used in their manufacture.
This is applicable whether you’re buying a stock item or you’re having an engineer and manufacturer design equipment to your specs. Once you have your equipment, you can set your IQ and OQ. But part of the job may already be done for you. The equipment manual should have IQ and OQ at least partially covered in the manual.
How Do I Complete the IQ, OQ, and PQ?
The first step will involve completing the IQ. This involves the equipment material. For instance, let’s say the manual claims the equipment comes with five parts, which assemble together using included screws. The equipment must assemble as the instructions state. If the equipment cannot assemble as it is intended the safety of your products is at stake due to lose or compromised components. Other items to be checked may include motors and power sources.
For OQ, this is the operational qualification. Let’s say your equipment manual claims it will run at 50 to 150 RPM at a specific draw of power. You need to verify that the equipment runs that fast, and has a specific power consumption. You’ll also need to ensure that the equipment performs the way you expect.
For the PQ or performance qualification, this is when you challenge the equipment when it’s in full operation. While the OQ validates that it runs at 50 to 150 RPM at a certain power consumption, now you’ll be testing it in actual operation, loaded with your products or ingredients. You need to know that the equipment will achieve these speed ranges even when loaded with items.
Once you have completed these three phases, and your equipment performs to par, it’s now ready to use in your manufacturing facility. Make sure that you have properly documented each step of the IQOQPQ process, or there will be no record to go back on later. Additionally, by drafting an IQOQPQ prior to qualifying the equipment, you’ll have a pre-determined set of specs that will allow you to qualify without bias.
Documenting the IQOQPQ
Documentation of an IQOQPQ does not merely mean reporting testing was completed. An IQOQPQ must include rationale for how the testing will prove the equipment is running correctly. It must include the sampling procedures that will be used, and what specifications will be applied to ensure the equipment is meeting expectations.
Often times equipment will be tested on R&D, or Research and Development, material prior to being released for use on actual product material. If the equipment passes the IQ and OQ, it can be tested using actual product material during live runs. It is important to note that any time product material is run on equipment that is still inthe qualification process, there is an increased risk for contamination or mishap in the product manufacture.
Not only will this give you the peace of mind to run your plant effectively, but also your clients or consumers too. The IQOQPQ is part of ensuring that the products you’re producing for the consumer market are safe for consumption, and that they’ll have the same efficacy whether batch 1 was produced yesterday, or batch number 1000 is produced next year.