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Frequently Asked Questions

What is cGMP?

cGMP stands for Good Manufacturing Practices. The "c" behind GMP refers to current, meaning the most current version. cGMP/GMP is a set of principles and system of processes that are part of the quality assurance in the manufacturing of therapeutic products, which when followed help to ensure that the final product is safe and meets the quality standards.

 

GMP was developed in 1967 by the World Health Organization (WHO) and published in 1968 and has gone through several revisions and development. "GMP shall be used as a standard to justify GMP status, which constitutes one of the elements of the WHO Certification Scheme on the quality of pharmaceutical products moving in international commerce, through the assessment of applications for manufacturing authorizations and as a basis for the inspection of manufacturing facilities". Annex 2. Good Manufacturing Practices for pharmaceutical products: main principles.

 

For cannabis producers, cGMP provides a competitive edge, as it is the generally required standard for Licensed Cannabis Producers in Europe (EU-GMP), home of the biggest cannabis market in the world. 

Why I should hire a project manager with knowledge in the industry?

Did you know that the Project Management Institute found that most projects are failures? This means that the projects don't meet the project scope, schedule or budget or all of them at the same time. A project manager that is knowledgeable of the GMP regulations and requirements from Health Canada and the cultivation and processing of the cannabis products while at the same time have the engineering skills will  help you stay on track with your schedule and budget to complete a successful project.

While GMP is a more rigorous process, it elevates the quality system. It is much easier and cost-effective to implement GMP standards from the initial design of your facility than it is after construction has commenced or the facility is already in operations.

I have completed my facility but I am not GMP compliant. What to do?

There is always a solution. Depending on where you are at with meeting GMP requirements, the solution could be costly, long and difficult but we will do our best to help you stay on track. Keep in mind that it might be required to halt operations to implement GMP. The only way to know where you are at and what needs to be done is to do an assessment of your facility and operations; that way we can make the custom solutions and recommendations for your final facility. The sooner you assess your facility, the more money and headaches it will save you. 

Who must comply with GMP?

Gmp regulations apply to:

  • Manufacturers

  • Packagers

  • Labelers

  • Importers

  • Distributors

  • Storage facilities

The importer is also responsible to ensure that the product being imported was manufactured, transported and stored according to GMP.

What are the 12 GMP key sections?

As outline in the GMP regulations, the 12 ket sections are:

  • Specifications

  • Premises 

  • Equipment

  • Personnel

  • Sanitation program

  • Operations

  • Quality Assurance

  • Stability

  • Records

  • Sterile product

  • Samples

  • Recall reporting