GMP FOR NEW YORK CANNABINOID HEMP PROGRAM

On October 28, 2020, New York State Governor Andrew Cuomo announced that the New York State Department of Health (DOH) has filed proposed regulations to regulate the cannabinoid hemp industry.  This program is expected to set quality control standards that all cannabinoid hemp processors and retailers will be required to meet to license their products called “GMP for New York Cannabinoid Hemp Program.” 

Manufacturers and processors of cannabinoid hemp products in the New York State must go through a third-party audit to obtain and maintain Good Manufacturing Practice (GMP) Certification. This is a requirement to obtain New York State licensure for cannabis, CBD, and hemp companies.

Currently, the U.S. Food and Drug Administration (FDA) does not qualify CBD to be used in food or dietary supplements. New York’s proposed regulations are expected to fill the regulatory gap left by the lack of a national standard by the FDA.

GMP CERTIFICATION FOR NEW YORK CANNABINOID, HEMP PROGRAM

GMP is the mandatory quality management system for producers of pharmaceuticals, medical devices, foods, beverages, dietary supplements, cosmetics, and other industries.  It requires companies to meet the hygienic quality requirements in accordance with relevant national regulations in terms of raw materials, personnel, facilitates, equipment production processes, packaging, transportation, and quality control.  

GMP for New York Cannabinoid Hemp Program will form an operable quality management and inspection system to ensure that the quality of the final product meets the requirements of the law. 

GMP AUDIT FOR NEW YORK CANNABINOID, HEMP PROGRAM

Evidence that GMP will be used in the extraction and manufacturing of cannabis, CBD, and hemp products shall include one of the following:

    1. Proof of a qualified third-party GMP audit of the applicant’s extraction and manufacturing processes
    2. A detailed plan for obtaining GMP audit within six months of approval of the application and before beginning operations.
GMP for New York Cannabinoid Hemp Program

GMP PROCESS FOR NEW YORK CANNABINOID, HEMP PROGRAM

New regulation imposes security and sanitary standards to create products for human consumption. Intermediate sales of hemp extract containing up to 3.0% THC are authorized, provided that the sale is between licensed processors. They must retain records of the following: 

    1. Extraction and manufacturing process
    2. Source of hemp or hemp extract
    3. Calibration and inspection of all equipment or instruments
    4. Disposal of hemp extract or hemp by-product
    5. Tracking and documentation of Δ9-Tetrahydrocannabinol (THC)
    6. Testing records of samples from lots or batches of product.

IMPORTANT SECTIONS OF PART 1005 TO TITLE 10 (HEALTH)

According to the proposed regulation, amendments add a new Part 1005 to Title 10 (Health) of the Official Compilation of Codes, Rules and Regulations of the State of New York, regulating the processing and retail sale of Cannabis, CBD, and Hemp in the State of New York.

The following are important sections of the New York State, Department of Health (DOH) Cannabinoid Hemp Regulation Part 1005 to Title 10 (Health):

Section 1005.1:  Defines terms  “cannabinoid hemp product,” “cannabinoid hemp processor,” “cannabinoid hemp retailer,” “hemp extract,” and “used for human consumption.”

Section 1005.2: Licensure and application requirements for cannabinoid hemp processors in New York State which includes requirements of Good Manufacturing Practices. (GMP for New York Cannabinoid Hemp Program)

Section 1005.3: Requirements to apply as a cannabinoid hemp retailer in New York State.

Section 1005.4: Criteria for licensure approval

Section 1005.5: Requirements for license renewal. 

Section 1005.6: Rules around transfers and amendments to licenses.

Section 1005.7: Requirements for cannabinoid hemp processors.

Section 1005.8: Requirements for cannabinoid hemp product to be sold at retail.

Section 1005.9:  Requirements for packaging and labeling of cannabinoid hemp products.

Section 1005.10: Requirements for laboratory testing of cannabinoid hemp products.

Section 1005.11: Requirements for cannabinoid hemp retailers.

Section 1005.12: Requirements for advertising cannabinoid hemp processors and retailers.

Section 1005.13 Additional standards and requirements to certify a product as a New York Hemp Product.

Section 1005.14: Requirements for manufacturing or selling cannabinoid hemp products.

Section 1005.15: Requirements related to product testing.

Section 1005.16: Describes specific prohibitions for cannabinoid hemp retailers.

 Section 1005.17: Penalties for non-compliance

 Section 1005.18 Requirements for distribution and delivery of out-of-state cannabinoid hemp products.

GMP CONSULTANTS FOR NEW YORK CANNABINOID HEMP PROGRAM 

Liberty Management Group (LMG) is a leading Quality Management System Consultant in the United States with over 14 years of experience in GMP, ISO 9001, ISO 13485, and CE Marking

Our GMP for New York Cannabinoid Hemp Program consultation service includes:

  • GAP analysis: Evaluation of your existing Quality Management System related to requirements of Title 21 CFR and Part 1005 to Title 10.
  • Documentation & Records: Development of documents such as quality manual, procedures, forms, templates, etc.
  • GMP for New York Cannabinoid Hemp Program Awareness: Training of your staff and management teams
  • SOP: Review of your Standard Operating Procedures
  • Implementation: Implementing a well-documented Quality Management System throughout your organization.
  • Internal Audit: identifying non-conformities related to GMP requirements.
  • MRM: Management Review Meetings
  • CAPA: Corrective and preventive actions /Root cause analysis addressing non-conformities.
  • External Audit: FDA / New York State Department of Health (DOH) audit support
  • Non-Conformities: Closing of any non-conformities found.
  • Certification: Referral for Third-Party GMP Certification for New York Cannabinoid Hemp Program.
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