Good Manufacturing Practices (GMP) Certification & Audits

GMP certification and audit services for cannabis facilities are offered by our consultancy, with a specific focus on the EU-GMP standards. Compliance with these guidelines is crucial for companies looking to export their cannabis products to European markets. The process of obtaining GMP certification involves a gap analysis of the facility, followed by remediation to bring it up to GMP standards, an audit, and certification if it passes. Our services include gap analysis, remediation assistance, audit preparation, and ongoing support.

The process of obtaining GMP certification typically involves several steps. These often include but are not limited to the following steps:

Gap analysis: This involves assessing the current state of the facility and identifying any areas that need improvement in order to meet GMP standards.

Remediation: Once the gaps have been identified, the facility will need to make the necessary changes to bring it up to GMP standards. This may involve implementing new procedures, training staff, and upgrading equipment and facilities.

Audit: Once the facility has made the necessary changes, it will be audited by a third-party auditor to ensure that it is in compliance with GMP standards.

Certification: If the facility passes the audit, it will be awarded GMP certification.

The timeline for obtaining GMP certification can vary, but typically takes several months to a year or more, depending on the complexity of the facility. At our consultancy, we have the expertise to guide your facility through the process of obtaining GMP certification, ensuring that your cannabis products meet the highest quality standards required for export to Europe.

As part of our project-scoping process, we would ask a few important questions to better understand your facility’s needs and objectives:

  1. What type of cannabis product and format are you interested in exporting?
  2. What countries or jurisdictions are you planning to export to?
  3. Does your facility currently have a robust Quality Management System (QMS)?
  4. Do you have validated equipment? If so, which equipment is validated?
  5. Do you have an automated packaging space to eliminate hand packing?
  6. Do you have a stability program in place?
  7. How many of your staff members are knowledgeable about GMP guidelines?
  8. Who will be the primary corporate decision-maker/approver throughout the GMP process to keep pushing the project forward?

At our consultancy, we have the expertise to help guide your facility through the GMP certification process and ensure compliance with EU-GMP standards. Our services include GMP gap analysis, remediation assistance, audit preparation, and ongoing support, and we can tailor our approach to your facility’s unique needs and budget.

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