EU GMP Certification for Cannabis Businesses

Good Agricultural and Collection Practices (GACP) and Good Manufacturing Practices (GMP) are a set of guidelines that provides a framework for ensuring that products are consistently produced and controlled according to recognized quality standards. These standards are applicable to cannabis as well as a wide range of established industries such as pharmaceuticals, food and beverage, cosmetics, and medical devices.

The GACP/GMP for cannabis applies to specific stages of the production process, from growing and harvesting of the cannabis plant to the processing, packaging, labelling, storage, and distribution of the final products, whether it be flower, oils, or other formats. As a result, the GACP/GMP guidelines emphasize minimizing risks of contamination, ensuring correct and consistent cannabinoid and terpene profiles, guaranteeing the absence of harmful substances, and ensuring correct labelling and packaging so that consumers are provided with high-quality, safe cannabis. 

GACP/GMP certification support and audit services for cannabis facilities are offered by our consultancy, with a specific focus on meeting standards for key markets such as Europe and Australia. Compliance with applicable GACP/GMP guidelines is crucial for companies looking to export their cannabis and can vary somewhat depending on the products and jurisdictions of interest. As a result, it’s crucial to have a global strategy that makes sense for your specific business. 

As part of our project-scoping process, we will ask several important questions to better understand your facility’s needs and objectives.

We provide the following GACP/GMP services:

Gap Audits and Global Strategy Support

Discover the strengths and areas for improvement in your cannabis GACP and GMP compliance through our comprehensive Gap Audits service. Our expert team will conduct a thorough evaluation of your processes and provide a detailed report, outlining the gaps and suggesting practical solutions to achieve compliance and ensure the applicable jurisdiction standards are met. For those seeking to become GACP or GMP certified by a competent regulatory authority, the timeline for certification issuance can vary, but typically takes several months to a year or more, depending on a variety of factors including the complexity of the facility, products to be exported, and jurisdictions of interests. Our experienced team will work with you to develop a market strategy to achieve your goals and guide you through the process. 

Risk Assessments

Mitigate risks and safeguard the integrity of your operations with our GACP/GMP Risk Assessments service. Our experienced professionals will assess potential hazards, vulnerabilities, and critical control points in your agricultural or manufacturing processes. By identifying risks early on, we help you implement appropriate validations and effective risk management strategies to ensure product safety and regulatory compliance.

Pre-inspection Preparation

Maximize your chances of a successful inspection through our GACP/GMP Pre-inspection Preparation service. Our experts will meticulously review your operations, documentation, and procedures, ensuring they align with GACP and GMP requirements. We will guide you in addressing any deficiencies, optimizing your facility, and training your staff to confidently handle inspections by regulatory authorities.

Regulatory Authority Inspection Coordination

Navigating the complexities of a regulatory authority inspection can be daunting. With our Inspection Coordination service, you can rely on our expertise to streamline the process. We will assist in scheduling the inspection, preparing documentation, and coordinating with regulatory authorities on your behalf. Our goal is to facilitate a smooth inspection experience and help you demonstrate compliance with GACP/GMP regulations.

Site Validation

Ensure the reliability and integrity of your cultivation, manufacturing, or testing site with our Site Validation service. Our team of qualified professionals will conduct a comprehensive assessment to validate your facility’s compliance with GACP/GMP standards. We extensively evaluate and establish validation for equipment, processes, systems, providing you with the assurance that your site meets the highest quality and regulatory requirements.

Change of Control Management

With our Change of Control Management service, you can navigate organizational transitions with confidence. We assist you in developing a robust change control plan, outlining the necessary steps and procedures to ensure GACP/GMP compliance throughout the transition. Our team supports you in implementing effective change management strategies, including documentation updates, training programs, and process modifications to safeguard the integrity of your operations, and maintain the highest quality standards.

Supplier Audits

Through our Supplier Audits service, we conduct audits of suppliers and vendors to assess their compliance with GACP/GMP standards. This helps ensure that the raw materials and ingredients used in your processes meet the necessary quality and safety criteria.

Quality Management System (QMS) Development

Our team of experts will assist in developing and implementing a robust QMS tailored to your organization’s needs with our QMS Development service. This includes establishing quality policies, defining procedures, and implementing effective documentation and record-keeping systems.

Product Quality and Testing Support

Ensure compliant finished products with our Product Quality and Testing Support service. We will provide guidance on product quality testing protocols, including analytical methods, sampling plans, and laboratory practices. We will also assist in establishing quality control procedures and specifications for finished products.

Cannabis Standard Operating Procedure (SOP) Writing

Streamline your operations and ensure consistency with our professional SOP Writing service. Our skilled technical writers will work closely with your team to develop clear, concise, and compliant SOPs tailored to your specific processes. By documenting standardized procedures, you enhance efficiency, minimize errors, and meet the stringent requirements of GACP/GMP guidelines.

Training and Education

Ensure employees at all levels understand the requirements and are equipped with the knowledge to implement and maintain compliance with our Training and Education service. We will provide comprehensive training programs and workshops on GACP/GMP principles and practices, with specific sessions applicable to your operations and goals.