Cannabis & GMP/GACP: Part 7 - Options

As mentioned in earlier posts, any software used for Good Manufacturing Practice-related activities must be validated in the facility at the time of certification. Even if a software system has been validated in another facility in the past, it will need to be validated in your facility if you are becoming Good Manufacturing Practice-certified.

But it isn’t just the cannabis management system that will need to be validated. Any software used in relation to compliance-related activities or data must be validated at the time of GMP certification.

In addition, every piece of equipment must also be validated for GMP. Since most equipment today relies heavily on software for its operation, all of that software will need to validated along with the equipment.

The process is not only time-consuming but extremely costly. Some organizations have reported spending up to two years with costs into six figures on the GMP certification process.

Is there another option? Yes.

If Canadian LPs wish to sell cannabis in Europe or other GMP regions, there are two options.
a) Become Good Manufacturing Practice certified OR
b) Become Goof Agricultural & Collection Practice certified and sell product in bulk to a producer who is GMP certified

There are pros and cons to both of these options.

While GMP certification lets producers sell their products directly to regions where it is required, as noted, the certification process involves validating every piece of equipment and software used in the facility. Plus, the cost for GMP certification is dependent on what products the licensed producer sells.

There is also a significant cost to maintaining a GMP certification including performing third-party vendor validations every two to three years as well as re-validating equipment and software when new releases/firmware updates are installed. These re-validation efforts require regression testing to perform complete process re-validation for all areas related to the specific equipment or software.

GACP certification does not permit producers to sell directly in GMP regions but does allow them to sell to GMP-certified producers. These certified producers can be in Canada or in the destination region.

Since GACP does not require third-party vendor validation nor equipment and software validation, time and costs to achieve certification are significantly reduced.

Whichever route you choose to take, if you use a cannabis management system in your facility, you should ensure that the software offers as many compliance-related features as possible.

If a software vendor claims their system is GMP-certified, it is not true. No software can become GMP-certified. A system can be validated in the GMP-certification process for a specific facility, but there is no GMP certification for software nor for equipment.
A software system having been validated in another facility that achieved GMP certification is an indication that it may meet compliance in your facility. But that is not a guarantee. If you are using software incorrectly or inconsistently, validation may fail.

And remember that all quality systems are heavily dependent on physical processes and practices. Software only supports the operation and supplies the recordkeeping and auditing. No software can make your facility GMP-compliant on its own.