What is GMP?

 

GMP stands for Good Manufacturing Practices.  GMPs are a set of rules and procedures related to every aspect of the end-to-end cycle from cannabis harvesting to final sale to the end-user, but more than that GMP is a mind-set and culture.  GMPs help ensure that products are consistently produced and controlled according to specific quality standards. Having a robust GMP program means the end-user can be sure that what they buy is safe to consume and that it is a consistent product every time it is made.

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GMPs encompass all aspects of production from the starting materials, manufacturing facility and equipment through distribution and sales of the final product.  GMPs are now an essential part of the cannabis industry, which includes growth and cultivation, extraction, infused products, retail, packaging/labeling, supply chain/distribution and laboratories.

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Why Now?

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Several countries have legislated that food and pharmaceutical manufacturers follow GMP procedures to ensure that a food or drug product is safe for human consumption.  State, county and local legislations exists that require cannabis producers to be licensed and it is nearly certain that in the future, federal cannabis regulations will require GMP certification (see California Code of Regulations, Title 17 for an example of state requirements).  Quality Management Systems (QMS) are not new to manufacturing, and have been well established by ISO guidelines and Pharmaceutical Good Manufacturing Practices.  

 

What Do We Do?

 

C&A can provide you with all of the services you need, some of which include:

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• Gap Assessment and Resolution:  A gap analysis is an examination of your current performance for the purpose of identifying the differences between your current state of business and where you'd like to be in regards to GMPs.  We can perform a full analysis of your operation and determine if GMP requirements are being met. We will provide a complete remediation plan to identify solutions that resolve your GMP gaps as well as helping you implement these solutions.

• Standard Operating Procedures:  Standard Operating Procedures (SOPs) is a written procedure for any process or system that is followed during the operation of any system or equipment.  SOPs are required to ensure the process is dependable and consistent.  We can generate your package of detailed, written SOPs that must be generated for each step of the process.

• Validation: Validation (Installation, operation and performance qualification) of your facility, manufacturing equipment and process must be performed to ensure your process is qualified and repeatable.  Per FDA Guidelines, this exercise establishes documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its pre-determined specifications and quality attributes.  Validation ensures the integrity of the system by showing that the system performs in a consistent manner and gives consistent performance as expected.

• Change Control: Change Control is a systematic approach to managing all change made to a product or system. The purpose is to ensure that no unnecessary changes are made, that all changes are documented and assessed properly and that the system is maintained in a validated state after the change is made.  We can implement a change control program for your equipment and operation.  Our team consists of change control managers who can generate summaries and justifications for any GMP change you may have to do to your operation and help manage the implementation plan for the change, through closure.

• Risk Assessment: A risk assessment is a systematic process of evaluating the potential risks that may be involved in a projected activity.  Managing your business risks is a process by which product quality and/or patient safety risks are assessed throughout the lifecycle of the product, process, or system.  Our team is proficient in performing assessments such as system impact assessments (SIAs), criticality assessments, preliminary hazard assessments (PHAs) and failure mode and effect assessment (FMEAs).  We used a risk based approach to tackle any quality or business risks you may have .

• Project Management: Our PMs will author GMP Project Plans, generate detailed project schedules and track milestones, manage and report on project budgets, evaluate bids and facilitate meetings.  With our specific experience in the pharmaceutical sector, our PMs possess a strong background of technical knowledge to ensure your project runs smoothly and efficiently.

• Construction Management:  Our team of managers utilizes specialized techniques to oversee the planning, design, and construction of a project, from its beginning to its end.  We have the ability to manage construction start-up or changes to your clean room facility and/or equipment.

• User Requirement Specification Generation: User requirements should be the starting point of any project you are working on. Time well-spent developing solid user requirements will help you enormously further down the line when you need to test your new equipment or process.  The requirements should define clearly and precisely what the system should do. We can help your team build the required specifications for your process and equipment.