Cannabis Cleanroom Environments & CGMP Guidance

by | Jan 17, 2020 | Cannabis Industry, CGMP, Cleanroom News, Cleanroom Standards

Cannabis Cleanroom Environments

Cannabis cleanrooms; ensuring a future of safety, compliance and sustainability. The future holds increased regulation and heightened production standards for the medical marijuana, Cannabis and CBD industries. New industry guidelines could pose issues for those who are not prepared, halting or even suspending production for those unable to comply with future federal regulations. Medical grade marijuana and medical CBD derivatives will inevitably be measured to the same standards that currently guide the pharmaceutical industry. 

CGMP Cannabis Cleanroom Environments

The FDA currently regulates sterile drug products produced by aseptic processing with a set of standards called cGMP (Current Good Manufacturing Practice). Sterile drug products are produced and packaged in an aseptic processing facility or cleanroom environment that are appropriately controlled to provide varying degrees of air quality depending on the nature of the operation. The design of the cleanroom environment involves satisfying microbiological and particle criteria as defined by the equipment, components, and products exposed, as well as the operational activities conducted in the area.

Under CGMP Pharmaceutical Cleanroom guidance, a class 100 cleanroom or critical area is one in which the sterilized drug product, containers, and closures are exposed to environmental conditions that must be designed to maintain product sterility. Activities conducted in such areas include manipulations of sterile materials prior to and during filling and closing operations.

Cannabis cleanroom environments are becoming the norm for medical grade marijuana and CBD producers. Complying with CGMP standards by operating in a cannabis cleanroom will ensure that your production environments meet the standards for quality and safety, increasing your product value and safeguarding your people and customers from safety issues.

Cannabis Cleanroom

 

Production in a Cannabis Cleanroom – A path to safety and compliance

In the future, through enhanced regulation and control, the medical marijuana industry will begin operating like the pharmaceutical industry, adhering to strict aseptic production standards, product testing, and conforming to environmental protocol and operational standards. Cannabis cleanroom environments are the new norm that will allow the medical marijuana producers to operate with safety and control, increasing the value of their products and paving a long sustainable road for growth and wellbeing.

As the legalization of medical marijuana expands across the United States there is an increase of federal regulation for the cultivation, production and packaging of medical marijuana and CBD. Precision Cleanrooms specializes in the design and construction of mission-critical cleanroom environments, designed and built to eliminate cross-contamination and bio-growth by using the highest quality materials for the cannabis industry.

Precision Cleanrooms is a leader of cleanroom design and construction for food and beverage, pharmaceutical and medical device industries, we design and construct turnkey modular cannabis cleanroom environments that comply with FDA, USDA, cGMP, USP 797 and USP 800 standards. Contact us today to learn more about our cannabis cleanrooms.

Where to go next?

Contact us for an assessment of your production process with the goal of ensuring that bioburden and sterility requirements are met in your cleanroom. We offer turnkey design and construction services, providing the perfect levels of cleanliness for the manufacturing and packaging of pharmaceutical products.

About CGMP Guidance for the Cannabis Cleanroom

Guidance for Industry Sterile Drug Products Produced by Aseptic Processing — Current Good Manufacturing Practice

This guidance is intended to help manufacturers meet the requirements in the Agency’s current good manufacturing practice (CGMP) regulations (2l CFR parts 210 and 211) when manufacturing sterile drug and biological products using aseptic processing. This guidance replaces the 1987 Industry Guideline on Sterile Drug Products Produced by Aseptic Processing (Aseptic Processing Guideline). This revision updates and clarifies the 1987 guidance.

For sterile drug products subject to a new or abbreviated drug application (NDA or ANDA) or a biologic license application (BLA), this guidance document should be read in conjunction with the guidance on the content of sterile drug applications entitled Guideline for the Submission of Documentation for Sterilization Process Validation in Applications for Human and Veterinary Drug Products (Submission Guidance). The Submission Guidance describes the types of information and data that should be included in drug applications to demonstrate the efficacy of a manufacturer’s sterilization process. This guidance compliments the Submission Guidance by describing procedures and practices that will help enable a sterile drug manufacturing facility to meet CGMP requirements relating, for example, to facility design, equipment suitability, process validation, and quality control.

FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.

For more information, visit: https://www.fda.gov/drugs/pharmaceutical-quality-resources/current-good-manufacturing-practice-cgmp-regulations

To learn more about our cannabis cleanroom environments, contact us.

1 This guidance was developed by the Office of Compliance in the Center for Drug Evaluation and Research (CDER) in cooperation with the Center for Biologics Evaluation and Research (CBER) and the Office of Regulatory Affairs (ORA).
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