N.J. Admin. Code § 17:30-11.12

Current through Register Vol. 56, No. 17, September 3, 2024

Section 17:30-11.12 - Manufacturing personnel: manufacturing supervisor

(a) A cannabis manufacturer shall designate a manufacturing supervisor who will be responsible for ensuring compliance with this subchapter, including ensuring that:

1. Cannabis products have been properly prepared, labeled, controlled, stored, sold, and distributed in accordance with the provisions of this standard;

2. All aspects of the manufacturing process are documented and that accurate manufacturing records for all cannabis products prepared by the cannabis manufacturer are maintained;

3. Manufacturing personnel are capable of, and qualified to perform, their assigned duties;

4. Ingredients used in manufacturing have their expected identity, strength, quality, and purity consistent with the requirements in this standard;

5. Cannabis products are manufactured with acceptable strength, quality, and purity, are packaged with appropriate packaging and labeling, and are prepared in accordance with good manufacturing practices;

6. Critical processes are recorded and validated to ensure that procedures will consistently result in the expected strength, quality, and purity in the finished cannabis products;

7. The manufacturing environment is suitable for its intended purpose;

8. Appropriate stability testing pursuant to N.J.A.C. 17:30-19.5 is performed, or is determined from literature, for establishing reliable expiration dating to ensure that the finished cannabis products have their expected strength, quality, and purity, at least until the labeled expiration date;

9. Manufacturing conditions and standard operating procedures are in place to minimize the potential for errors; and

10. Adequate procedures and records exist for investigating and correcting failures or problems in manufacturing, quality control, or in the cannabis product itself.

(b) Personnel employed by the cannabis manufacturer shall have appropriate education and/or experience to assume responsibility for positions that would affect compliance with this subchapter.

(c) The manufacturing supervisor shall report any confirmed failure of a cannabis product to meet the standard of acceptable strength, quality, purity, packaging, and labeling to the Commission within 24 hours of incident confirmation.

N.J. Admin. Code § 17:30-11.12

Adopted by 53 N.J.R. 1583(a), effective 8/19/2021

Amended by 55 N.J.R. 402(a), effective 3/6/2023