N.Y. Comp. Codes R. & Regs. tit. 9 § 130.10

Current through Register Vol. 46, No. 43, October 23, 2024

Section 130.10 - Laboratory Regulatory Audit

(a) A cannabis laboratory shall maintain an ISO/IEC 17025 accreditation, or accreditation that is based on ISO/IEC 17025 accreditation by any other laboratory accreditation authority approved by the Office.

(b) A cannabis laboratory shall have a laboratory regulatory audit every two (2) years during a cannabis laboratory's normal business hours.

(c) The factors to be considered during a laboratory regulatory audit shall include, but not be limited to, the competence and qualifications of staff as specified in this Part, adequacy of facilities and equipment, appropriateness of sampling protocols, use of approved methods, and a cannabis laboratory's quality system, including, but not limited to, quality assurance and quality control procedures, and record keeping and reporting practices.

(d) A cannabis laboratory shall demonstrate effective implementation of its quality system for planning and assessing work performed by a laboratory regulatory audit, and for conducting required quality assurance and quality control procedures to promote and maintain the accuracy and reliability of test results.

(e) A cannabis laboratory, following a laboratory regulatory audit, shall obtain an audit report which shall set forth any recommendations of the audit and any findings to be corrected.

(f) If findings are found during a laboratory regulatory audit, a cannabis laboratory may be granted a grace period not to exceed ninety (90) calendar days from the date of audit report to correct the findings, provided that, within thirty (30) calendar days of such audit report, a cannabis laboratory shall submit, within thirty (30) days of the laboratory regulatory audit to the Office or another laboratory accreditation authority as approved by the Office performing the audit a written plan of correction to be implemented within ninety (90) calendar days from the date of audit report to correct the findings. If at the end of the grace period any of the findings remain uncorrected, the affected analyte or group of analytes pursuant to this Part will be unapproved.

(g) If the findings do not have an effect or do not have an immediate effect on either the accuracy or reliability of results, and if a cannabis laboratory demonstrates in writing that corrections of findings have been delayed for reasons beyond its control, the grace period granted pursuant to this subsection may be extended further for a period not to exceed ninety (90) calendar days. Such extension may not be extended further.

N.Y. Comp. Codes R. & Regs. Tit. 9 § 130.10

Adopted New York State Register March 22, 2023/Volume XLV, Issue 12, eff. 3/22/2023