Quality & Compliance

Compliance and Quality Assurance

Gaylord Chemical Company, LLC is committed to meeting and exceeding both international and domestic standards for quality, reliability, and compliance. Gaylord is dedicated to a process of continuous improvement and is always in pursuit of increased efficiency and efficacy of our quality management systems.

Gaylord Chemical manufactures DMSO and supports the production of DMS under the ISO 9001:2015 Quality Management system.

Procipient® (Dimethyl Sulfoxide USP, PhEur) is manufactured according to Current Good Manufacturing Practices (cGMP) following ICH Q7 guidelines.

Gaylord Chemical is committed to the highest level of Quality and Compliance for its Products and Services in alignment with international standards:

  • ISO 9001:2015
  • cGMP for Procipient® per ICH Q7 guidelines
  • Kosher Parve
  • Halal Guidelines
  • Stringent Quality Control

ISO 9001:2015

Gaylord Chemical Company’s entire corporate structure is certified to the ISO 9001:2015 Quality System.

This Quality System encompasses all service and support functions as well as the manufacturing of DMSO at our Tuscaloosa, Alabama, USA production facility.

Please contact us to request Gaylord’s ISO 9001:2015 for all grades of DMSO.

The manufacturing of Procipient® (Dimethyl Sulfoxide USP, Ph.Eur) is excluded from Gaylord’s ISO 9001:2015 Quality system.

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Current Good Manufacturing Practice (cGMP)

Procipient® (Dimethyl Sulfoxide USP, Ph. Eur) is manufactured and packaged according to Current Good Manufacturing Practices (cGMP) following ICH Q7 Guidelines for API production. Procipient meets and exceeds both the U.S. Pharmacopoeia and the European Pharmacopoeia.

Procipient®(Dimethyl Sulfoxide USP, Ph.Eur) is supported by a Type II Drug Master File (DMF) with the FDA, a CEP granted by EDQM and a Type I DMF with Health Canada.

Our Procipient®(Dimethyl Sulfoxide USP, Ph.Eur) manufacturing facility is inspected by the US FDA with a remarkable inspection history.

 

 

Quality Control

Gaylord Chemical Company utilizes the most up-to-date analytical instrumentation to analyze our products and guarantee it meets its required specification.

If you need assistance with DMSO analytical methods, contact us for more information.

REACH Compliance

DMSO is fully compliant with REACH (Registration, Evaluation, Authorisation, and Restriction of Chemicals) regulations established in the European Union under Regulation (EC) No 1907/2006. DMSO is not on the list of ‘Substances of Very High Concern’ (SVHC) and is not carcinogenic, mutagenic, toxic for reproduction, or bioaccumulative.

Additional Certifications

Kosher Parve Certified

Halal Certified Facility

Please contact us for more information and to request any of these certificates.

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