Commitment to Quality

Commitment to Quality

Commitment to Quality and Compliance

At Australian Alkaloids, we are dedicated to providing our customers with the highest quality Hyoscine products. This commitment extends beyond our innovative manufacturing processes and encompasses a rigorous approach to quality control and assurance.

Stringent Quality Assurance:

We maintain a robust quality assurance system that encompasses all aspects of our operations, from raw material sourcing to product distribution. This system ensures that all our processes comply with the highest quality standards and regulations.

Rigorous Quality Control:

Our commitment to quality is further demonstrated by our comprehensive quality control measures implemented throughout the entire production process. We employ extensive analytical testing at every stage of production, from the initial extraction of Hyoscine from Duboisia leaves to the final packaged product. This ensures the consistent quality and purity of our products.

A TGA Manufacturing License, is issued by the Therapeutic Goods Administration (TGA) of Australia. This license authorizes manufacturing sites in Australia to produce therapeutic goods for supply within or export from the country.

Australian Alkaloids holds a TGA manufacturing license for the manufacture of API’s, demonstrating that the facility meets the TGA’s strict quality and safety standards, ensuring the manufactured products are compliant with GMP guidelines.

A GMP certificate (Good Manufacturing Practice certificate) is a document issued by an accredited certification body to a manufacturer, signifying that their facility, processes, and systems comply with established Good Manufacturing Practice (GMP) guidelines.

Australian Alkaloids holds a current GMP certification, demonstrating compliance to the Guide of Good Manufacturing Practices for Medicinal Products Part II.

GMP certification has been issued by both the Therapeutic Goods Administration (TGA) of Australia and the Brazilian Health Regulatory Agency (ANVISA).

EP compliance refers to adhering to the standards set forth in the European Pharmacopoeia (EP), a compendium of quality standards for medicines published by the European Directorate for the Quality of Medicines & HealthCare (EDQM).

Australian Alkaloids maintains EP compliance for both the Hyoscine Butylbromide API and the Hyoscine Hydrobromide Intermediate. Certificates of analysis are issued for both products with EP compliance.

A CEP is a certificate issued by the European Directorate for the Quality of Medicines & HealthCare (EDQM) to manufacturers of Active Pharmaceutical Ingredients (APIs) or pharmaceutical ingredients. The certificate confirms that the API or ingredient complies with the standards set out in the European Pharmacopoeia (EP), a quality standard book for medicines in Europe.

Australian Alkaloids maintains a CEP for Hyoscine Butylbromide, which has been in place since 2016.

An Active Substance Master File (ASMF) is a technical document created and maintained by the manufacturer of an Active Pharmaceutical Ingredient (API). It essentially serves as a comprehensive dossier containing all the necessary information about the API, allowing for a streamlined review process for marketing authorization applications.

Australian Alkaloids holds a current ASMF for Hyoscine Butylbromide. The Applicants part is available on request.