Standardized Testing Policy
For ISO 17025 Laboratories
This document outlines the testing standards and protocols required by XPharms Xchange for ISO/IEC 17025-accredited laboratories performing medicinal cannabis analysis. It ensures all results are standardized and compliant with global import requirements, including Australia (TGO 93), EU (Ph. Eur.), UK (MHRA), Israel (IMC-GMP), South Africa (SAHPRA), and Germany (DAB).
Policy Statement
To be recognized and approved by XPharms Xchange, all laboratories must:
- •Be ISO/IEC 17025 accredited with scope relevant to medicinal cannabis.
- •Follow validated, harmonized methods aligned with official pharmacopoeias (e.g., Ph. Eur., USP, DAB) and global regulatory standards (e.g., ICH Q3D, EU SANTE, TGO 93).
- •Perform testing using specific analytical techniques and method references as outlined below—these must not be substituted without prior written approval from XPharms technical oversight.
- •Demonstrate method suitability through inter-laboratory validation, appropriate system suitability checks, and consistent proficiency test results.
- •Submit Certificate of Analysis (COA) in the XPharms Xchange standard format, clearly indicating method references, units, quantitation values, pass/fail criteria, and analyst signature.
Note:
ISO/IEC 17025 accreditation ensures competence in laboratory operations, but does not prescribe exact testing methods. Therefore, XPharms Xchange mandates all approved labs adopt standardized test procedures to meet the global import specifications that apply across all destination markets.
Mandatory Test Panel and Methodology Requirements
| Test | Method Name | Reference | Limits / Requirements | Applicability |
|---|---|---|---|---|
| Cannabinoid Assay | HPLC-UV (C18 column) | Ph. Eur. monograph 3028 | Quantitative assay of THC, THCA, CBD, CBDA, etc. Must meet 90–110% of label claim. Use external standard or calibration curve. | Global (AUS, EU, UK, US, ISR) |
| Moisture Content | Loss on Drying | Ph. Eur. 2.2.32 | ≤12% moisture (dried under vacuum at 40°C) | Global |
| Foreign Matter | Visual & Microscopic Inspection | Ph. Eur. 2.8.2 | ≤2% extraneous matter, no fragments >10 mm | Global |
| Heavy Metals | ICP-MS | Ph. Eur. 2.4.27 / ICH Q3D | Pb ≤ 5.0 µg/g, Cd ≤ 1.0 µg/g, Hg ≤ 0.1 µg/g, As ≤ 1.5 µg/g. Applicable to flower and extracts. | TGO 93, EU-GMP, IMC-GMP, SAHPRA |
| Microbial Contamination | Culture & PCR (Harmonized) | Ph. Eur. 2.6.12 / 2.6.13 / USP <61>, <62> | TAMC ≤ 100,000 CFU/g, TYMC ≤ 10,000 CFU/g, Pathogens absent in 1–10g, BTGNB (oral) ≤ 100 CFU/g | TGO 93/100, EU-GMP, IMC-GMP, Annex 7 |
| Mycotoxins | LC-MS/MS with IAC cleanup | Ph. Eur. 2.8.18 | Aflatoxin B1 ≤ 2 µg/kg; Total ≤ 4 µg/kg; Ochratoxin A ≤ 20 µg/kg | Global |
| Pesticides | LC-MS/MS / GC-MS (Multi-Residue) | Ph. Eur. 2.8.13 / TGO 93 Schedule 1 | Compliant with: Aldrin + Dieldrin ≤ 0.02 mg/kg; DDT (total) ≤ 0.05 mg/kg; Endrin ≤ 0.01 mg/kg; Chlordane ≤ 0.05 mg/kg; Permethrin ≤ 1.0 mg/kg; Israel: ≤ 0.01 mg/kg or 10% Codex MRLs, others ND | TGO 93, EU, Israel, SAHPRA |
| Residual Solvents | GC-FID | USP <467> / Ph. Eur. | Class I–III solvents. Ethanol ≤ 5,000 ppm; Hexane ≤ 290 ppm; Benzene = ND | Global |
Approved Laboratory Network
| Laboratory Name | Country | Accreditation | Website | Contact Details |
|---|
Global Laboratory Network
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