N.D. Admin Code 33-44-01-55 - Manufacturing facility quality control and quality assurance program

1. A manufacturing facility shall develop and follow a written quality control and quality assurance program. The program must be established to protect qualifying patient health and implemented in a manner to assist in complying with testing required in sections 33-44-01-42, 33-44-01-43, and 33-44-01-44. A manufacturing facility is not prohibited by these rules to test marijuana and usable marijuana as part of a quality control and quality assurance program.

2. A quality control and quality assurance program must include an assessment of the profile of the active ingredients, including expiration date, and the presence of inactive ingredients and contaminants. Testing results must be used to determine appropriate conditions and expiration dates.

3. A manufacturing facility shall develop and follow written procedures for sampling marijuana and usable marijuana. Procedures must be developed related to sampling methods, sample collection, and documentation of sampling. Test results from random samples must be retained for at least three years.

4. The manufacturing facility shall develop and follow written procedures for performing stability testing of usable marijuana to determine product expiration date. Once an expiration date has been determined through testing described in subsection 5, a manufacturing facility must perform periodic stability testing to verify expiration dates.

5. If stability testing has not been completed within one year of production, a manufacturing facility may assign a tentative expiration date based on available stability information. Stability testing is to include, at a minimum, an assessment of microbiological contaminants and mycotoxins, heavy metals, and concentration. When applicable, the stability testing must include water activity and moisture content or solvents. If an expiration date is one year or less, at a minimum, a stability test must be performed once before fifty percent of the period has expired and at the end of the expiration date. If an expiration date is more than one year, at a minimum, a stability test must be performed at no less than six-month intervals and at the end of the expiration date. After the manufacturing facility verifies the tentative expiration date, or determines the appropriate expiration date, the manufacturing facility shall include the expiration date on each batch of marijuana or usable marijuana.

6. A manufacturing facility shall retain a uniquely labeled reserve sample representing each harvest lot, process lot of cannabinoid concentrate to be packaged in a container for transfer to a dispensary, and process lot of medical cannabinoid product for at least one year following the expiration date. The reserve sample must be stored in the same immediate container-closure system the usable marijuana is packaged in for dispensaries, or in one that has similar characteristics. The reserve sample must consist of at least twice the quantity necessary to perform all required tests.

Notes

N.D. Admin Code 33-44-01-55

Adopted by Administrative Rules Supplement 368, April 2018, effective 4/1/2018. Amended by Administrative Rules Supplement 374, October 2019, effective 10/1/2019.

General Authority: NDCC 19-24.1-36

Law Implemented: NDCC 19-24.1-36