"Quality is not an accident; it is always the result of high intention, sincere effort, intelligent direction and skillful execution; it represents the wise choice of many alternatives."
Our Facility
Quality for manufacturing homeopathic medicines starts at the site location. Our shielded facility has 18-inch steel-reinforced concrete walls, protecting it from the elements and insulating it from electromagnetic disturbances. We also have an underground level, making it the ideal manufacturing site for the purest homeopathic remedies. We are one hour and fifteen minutes from Dallas/Fort Worth airport, in the countryside, in a pollution-free environment.
Our Practices
OHM provides homeopathic medicines made with individual care, using traditional methods complying with current Good Manufacturing Practices (cGMP). We implement high quality standards for manufacturing medicines in strict accordance with the Food and Drug Administration (FDA) and the Homeopathic Pharmacopoeia of the United States (HPUS).
OHM is registered and inspected by the FDA and registered with Health Canada as a Foreign Manufacturing site. Standardizing the manufacturing processes guarantees optimal reliability and reproducibility of the attenuations.
Testing Methods
All testing methods employed at OHM are based on established pharmacopeial standards. These include the Homeopathic Pharmacopoeia of the United States (HPUS), which is specifically tailored for homeopathic medicines, and the United States Pharmacopeia/National Formulary (USP/NF), which provides comprehensive guidelines for pharmaceutical testing. In cases where additional specificity is required, we refer to other reputable pharmacopeia monographs, ensuring that our testing methods align with the highest industry standards and regulatory requirements.
Also, other testing is performed as needed.
Water Testing
- TOC (Total Organic Compound) analyzer for in-line continuous testing.
- pH meter and conductivity meter for daily water testing.
- Microbial Limit Tests according to the USP requirements, including Burkholderia cepacia complex.
Raw Material Testing in Incoming Process
- Identification test using FT-IR (Fourier transform infrared spectroscopy).
- Identification test using UV-VIS (Ultraviolet-visible spectrophotometry).
- Identification test using HPTLC (High-performance thin-layer chromatography).
- Identification and assay test using HPLC (High-performance liquid chromatography).
- Heavy metals test using ICP-MS (Inductively coupled plasma mass spectrometry).
- Pesticides test using LC-MS/MS, GC MS/MS, GC-MS (Triple quadrupole mass spectrometers, Triple quadrupole gas chromatography-mass spectroscopy, Gas chromatography-mass spectroscopy).
- Alcohol testing: each incoming lot of alcohol used in production is tested for methanol impurities by GC (Gas chromatography).
- Glycerin testing: each incoming lot of glycerin is tested for a limit of diethylene glycol and ethylene glycol using GC (Gas chromatography).
Finish Product Testing
- Microbial Limit Tests applicable for each dosage form (Total Anaerobic Plate Count, Total Yeast and Mold Count, E. coli, Salmonella, Staphylococcus, Pseudomonas, Burkholderia cepacia complex).
- Suitability testing.
- Physical testing (organoleptic tests, pH, specific gravity, alcohol content, viscosity, disintegration, breaking force, weight, size and thickness, friability).
- Heavy metals test using ICP-MS (Inductively coupled plasma mass spectrometry).
- Pesticides test using LC-MS/MS, GC MS/MS, GC-MS (Triple quadrupole mass spectrometers, Triple quadrupole gas chromatography-mass spectroscopy, Gas chromatography-mass spectroscopy).
- Stability testing in environmental chambers (accelerated and long-term storage conditions).
- Identification test when detectable using HPTLC (High-performance thin-layer chromatography).
- Identification and assay test when detectable using HPLC (High-performance liquid chromatography).
Homeopathic medicines are manufactured in strict accordance with cGMP, FDA and HPUS.
