18-691 C.M.R. ch. 4, § 5 - Registered Manufacturing Facility Policies and Procedures

5.1 - Standard Operating Procedures

A. Each registered manufacturing facility must maintain written standard operating procedures that are easily accessible to on-site personnel for each product or concentrate it manufactures.

(1) Standard operating procedures must be available for review on-site when requested by the Department.

(2) Those procedures that the facility considers a trade secret must be clearly identified by the facility. The Department may consider specified trade secrets confidential if it determines such procedures meet the definition of trade secrets in 10 MRS §1542(4), except procedures or practices that are determined hazardous to public health and safety and violate authorizations of the Act are not trade secrets.

B. The standard operating procedures must, at minimum, include the following:

(1) Detailed step-by-step instructions of each required process to manufacture marijuana products or concentrate, including but not limited to methods, use of equipment in accordance with manufacturer's instructions, and applicable sanitary rules and safety measures.

(2) For extraction involving inherently hazardous substances, additional detailed instructions to:

(a) Conduct all necessary safety checks prior to commencing production;

(b) Prepare marijuana for manufacturing;

(c) Extract cannabinoids and other essential components of marijuana;

(d) Purge any solvent or other unwanted components from a marijuana concentrate; and

(e) Clean all equipment, counters and surfaces thoroughly;

(3) Policies or procedures developed in accordance with the security requirements in Section 6 of these rules;

(4) Emergency response procedures, including in case of a fire, chemical spill or other emergency;

(5) Inventory control procedures for preventing unlawful diversion of marijuana and for tracking the amount of marijuana in possession of the facility;

(6) Waste management procedures in compliance with Section 13 of these rules;

(7) Policies and procedures for taking marijuana samples for required testing specified in Section 10 of these rules; and

(8) Procedures for organizing tracking batches of marijuana product and concentrates , which includes tracking and reporting weight and/or count.

5.2 - Record Keeping and Audits

5.2.1 Record Keeping.

A. A manufacturing facility must maintain records of all transfers, inventory, transactions and chain of custody forms for a minimum of one year. All records must be made available to the Department upon request.

B. The Department, at its sole discretion, may require a registered manufacturing facility to account for all inventory through a centralized track and trace software system. A manufacturing facility must comply with all reporting requirements of the designated electronic data system.

C. All personnel records must be current and complete.

5.2.2. Internal Audit. The registered manufacturing facility must conduct an internal audit at least once per year.

A. The internal audit must at a minimum:

(1) Examine the manufacturing facility's compliance with the requirements of this rule and identify required updates to, including but not limited to, standard operating procedures, employee records, and training records that must be updated;

(2) Report and reconcile any discrepancies in surplus or unaccounted marijuana held in inventory; and

(3) Immediately report any material deficiencies and non-compliant findings to the Department along with a plan for correcting deficiencies ("corrective action plan") and gaining compliance.

B. The Department may take administrative or disciplinary action based on the findings of the audit or place additional reporting requirements as part of a corrective action plan to ensure compliance is obtained.

C. If no material deficiencies or non-compliant findings are discovered, then the registered manufacturing facility will report the findings of the audit to the Department at the time of application or request.

Notes

18-691 C.M.R. ch. 4, § 5