GMP is a requirement to obtain a manufacturing/processing license for cannabis. New York State is the first state in the nation that created a regulatory structure to oversee the licensure, cultivation, production, distribution, sale, and taxation of medical, and adult-use cannabinoid hemp. The Marijuana Regulation and Taxation act was signed into law on March 31, 2021, legalizing adult-use cannabis. The legislation created a new office of Cannabis Management, which will be responsible for issuing and regulating this new industry. .
Industries manufacturing or processing cannabinoid hemp products for human consumption are required to obtain a license from the New York State Cannabis Management. Proof of this Good Manufacturing Practice audit is a requirement for Cannabinoid Hemp Processor Application, referred to as GMP for New York Cannabis Management. LMG New York offers GMP consulting services for the New York State Cannabis Management program.
GMP for New York Cannabis Management is a quality management system that ensures that the products are consistently produced and controlled in accordance with 21 CFR Parts 111 or 117 developed by the US FDA described in Title 21 of the code of federal regulations.
SECTIONS IN 21 CFR 111
Important sections in Part 111 Current Good Manufacturing Practice in manufacturing, packaging, labeling, or holding operations for dietary supplements are as follows:
- Subpart A – General Provisions
- Subpart B – Personnel
- Subpart C – Physical Plant and Grounds
- Subpart D – Equipment and Utensils
- Subpart E – Requirement to Establish a Production and Process Control System
- Subpart F – Production and Process Control System: Requirements for Quality Control
- Subpart G – Production and Process Control System: Requirements for Components, Packaging, and Labels and for Product That You Receive for Packaging or Labeling as a Dietary Supplement
- Subpart H – Production and Process Control System: Requirements for the Master Manufacturing Record
- Subpart I – Production and Process Control System: Requirements for the Batch Production Record
- Subpart J – Production and Process Control System: Requirements for Laboratory Operations
- Subpart K – Production and Process Control System: Requirements for Manufacturing Operations
- Subpart L – Production and Process Control System: Requirements for Packaging and Labeling Operations
- Subpart M – Holding and Distributing
- Subpart N – Returned Dietary Supplements
- Subpart O – Product Complaints
- Subpart P – Records and Recordkeeping
Licensed processors are required to retain records of the following:
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- Extraction and manufacturing process
- Source of hemp or hemp extract
- Calibration and inspection of all equipment or instruments
- Disposal of hemp extract or hemp by-product
- Tracking and documentation of Δ9-Tetrahydrocannabinol (THC)
- Testing records of samples from lots or batches of products.
GMP Audit for New York Cannabis Management Program
In order to obtain the license for cannabinoid hemp processing or manufacturing, processors are required to obtain a Good Manufacturing Practice (GMP) audit of their processing facilities. This GMP Audit for New York Cannabis Management Program is a third-party audit for your facility by an approved GMP auditor by the New York State Department of Cannabis Management.
GMP Consultant for New York Cannabis Management Program
Liberty Management Group (LMG) is a leading GMP consultant for New York State Cannabis Management program. Our consultation service includes:
- GMP GAP analysis: Analyzing your existing Quality Management System related to requirements of Title 21 CFR 111.
- GMP Documentation & Records: Developing all the mandatory documents such as quality manual, procedures and providing assistance with necessary forms and templates to create required records.
- GMP for New York Cannabis Management Awareness: Training of your employees about the various aspects of the quality management system.
- SOP: Providing assistance with creating and reviewing your Standard Operating Procedures.
- GMP for New York Cannabis Management Implementation: Implementing a well-documented Quality Management System throughout your organization.
- GMP Internal Audit: identifying non-conformities related to GMP for New York Cannabis Management requirements.
- MRM: Management Review Meetings
- CAPA: Corrective and preventive actions /Root cause analysis addressing non-conformities identified by the customers or internal audit.
- GMP Audit: Assistance and support with third-party audit required by GMP for New York Cannabis Management.
- Non-Conformities: Closing of any non-conformities identified by the internal and certification auditors.
- Certification: Referral to approved Cannabinoid Hemp Third Party GMP Auditor approved by the New York State Cannabis Management.
FREE GMP CONSULTATION: Liberty Management Group (LMG) offers a free, onsite GMP consultation. Whether you are just starting out on building a quality management system from scratch or need to evaluate your existing system for GMP certification, our experienced consultants will be able to give advice and guide you through the entire process of implementation and certification of Good Manufacturing Practice.
After the initial onsite visit, we will provide you with an estimate of the cost and time frame of the GMP implementation and certification process. No contract or commitment is required unless LMG is selected to provide any further service.
