Quality and Compliance

Aspen Pharmacare has an established Compliance Program that reflects our commitment to providing high quality products and to complying with all of the laws and regulations governing pharmaceutical manufacture, marketing, distribution and sales.

To support this program Aspen employs an extensive team of professional staff across Australia and participates in regular inspections of our manufacturing sites by authorities, as well as quality audits initiated by existing and potential customers.

Our program consists of three main functional areas:

Quality Control and Quality Assurance - covers all practices that influence the quality of every product, with the goal of ensuring each product, is of the quality required for its intended use, and has been manufactured according to the Australian code of Good Manufacturing Practice (GMP) for Medicinal products. Quality Assurance is a wide ranging concept which covers all matters which influence the quality of each product and embraces Quality Control and GMP using up-to-date quality management systems.

Regulatory & Medical Affairs - Our Regulatory & Medical Affairs Department (RMAD) is the primary interface between Aspen and the regulatory bodies and ensures products meet the regulatory and relevant compendium requirements. RMAD manages pharmacovigilance activities, product enquiries, customer complaints, adverse drug reactions and adverse events.

Technical Compliance - provides technical support to ensure product quality and Good Manufacturing Practice adherence, particularly in the areas of product stability, validation and quality release for sale systems.

About the industry

The Australian Pharmaceutical Industry is governed by the Therapeutic Goods Act 1989. The Therapeutic Goods Administration (TGA) is the government department responsible for administering the Act. Any product for which therapeutic claims are made must be either listed or registered in the Australian Register of Therapeutic Goods (ARTG) before it can be supplied in Australia.

The Act, Regulations and Orders set out the requirements for inclusion of therapeutic goods in the ARTG.

Further information on the regulations and industry can be located by clicking on the following links:

 

 

Scientific Affairs

Aspen Pharmacare has an established Compliance Program that reflects our commitment to providing high quality products and to complying with all of the laws and regulations governing pharmaceutical manufacture, marketing, distribution and sales.